1998-37-EC_-_Machinery_Directive
国际食品机械设备卫生安全标准与重要法规
➢ Determining limits for safe food ➢ Food safety criteria for best before date (BBD) ➢ Process hygiene criteria during manufacturing
Annex II (food business operators)
Surfaces (including surfaces of equipment) … will require the use of smooth, washable, corrosion resistant and non-toxic materials, …(Chapter II)
Basic hygiene principles Food & feed business operator: legal
responsibility for ensuring product safety Unsafe foodstuffs may not be placed on
the market Traceability Consideration of long-term, cumulative
HACCP based on principles of Codex Alimentarius
Control and documentation requirement during the whole production process
Registration is mandatory for all food
2006_42_EC Machinery Safety
DIRECTIVE2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof17May2006on machinery,and amending Directive95/16/EC(recast)(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-PEAN UNION,Having regard to the Treaty establishing the European Com-munity,and in particular Article95thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article251of the Treaty(3),Whereas:(1)Directive98/37/EC of the European Parliament and ofthe Council of22June1998on the approximation ofthe laws of the Member States relating to machinery(4)codified Directive89/392/EEC(5).Now that newsubstantial amendments are being made to Directive98/37/EC,it is desirable,in order to clarify matters,thatthat Directive should be recast.(2)The machinery sector is an important part of the engi-neering industry and is one of the industrial mainstaysof the Community economy.The social cost of the largenumber of accidents caused directly by the use ofmachinery can be reduced by inherently safe design andconstruction of machinery and by proper installationand maintenance.(3)Member States are responsible for ensuring the healthand safety on their territory of persons,in particular ofworkers and consumers and,where appropriate,ofdomestic animals and goods,notably in relation to therisks arising out of the use of machinery.(4)In order to ensure legal certainty for users,the scope ofthis Directive and the concepts relating to its applicationshould be defined as precisely as possible.(5)The Member States'mandatory provisions governingconstruction site hoists intended for lifting persons orpersons and goods,which are often supplemented by defacto compulsory technical specifications and/or byvoluntary standards,do not necessarily lead to differentlevels of health and safety but,because of their dispari-ties,do nevertheless constitute barriers to trade withinthe Community.Moreover,the national systems for theconformity assessment and certification of thesemachines diverge considerably.It is therefore desirablenot to exclude from the scope of this Directive construc-tion site hoists intended for lifting persons or personsand goods.(6)It is appropriate to exclude from the scope of this Direc-tive weapons,including firearms,that are subject toCouncil Directive91/477/EEC of18June1991oncontrol of the acquisition and possession of weapons(6);the exclusion of firearms should not apply to portablecartridge-operated fixing and other impact machinerydesigned for industrial or technical purposes only.It isnecessary to provide for transitional arrangementsenabling Member States to authorise the placing on themarket and putting into service of such machinerymanufactured in accordance with national provisions inforce upon adoption of this Directive,including thoseimplementing the Convention of1July1969on theReciprocal Recognition of Proofmarks on Small Arms.Such transitional arrangements will also enable the Euro-pean standardisation organisations to draft standardsensuring the safety level based on the state of the art.(7)This Directive does not apply to the lifting of persons bymeans of machines not designed for the lifting ofpersons.However,this does not affect the right ofMember States to take national measures,in accordancewith the Treaty,with respect to such machines,with aview to implementing Council Directive89/655/EEC of30November1989concerning the minimum safety andhealth requirements for the use of work equipment byworkers at work(second individual Directive within themeaning of Article16(1)of Directive89/391/EEC)(7).(1)OJ C154E,29.5.2001,p.164.(2)OJ C311,7.11.2001,p.1.(3)Opinion of the European Parliament of4July2002(OJ C271E,12.11.2003,p.491),Council Common Position of18July2005(OJ C251E,11.10.2005,p.1)and Position of the European Parlia-ment of15December2005(not yet published in the OfficialJournal).Council Decision of25April2006.(4)OJ L207,23.7.1998,p. 1.Directive as amended by Directive98/79/EC(OJ L331,7.12.1998,p.1).(6)OJ L256,13.9.1991,p.51.(8)In relation to agricultural and forestry tractors,the provi-sions of this Directive concerning the risks currently notcovered by Directive2003/37/EC of the European Parlia-ment and of the Council of26May2003on type-approval of agricultural or forestry tractors,their trailersand interchangeable towed machinery,together withtheir systems,components and separate technicalunits(1)should no longer apply when such risks arecovered by Directive2003/37/EC.(9)Market surveillance is an essential instrument inasmuchas it ensures the proper and uniform application ofDirectives.It is therefore appropriate to put in place thelegal framework within which market surveillance canproceed harmoniously.(10)Member States are responsible for ensuring that thisDirective is effectively enforced on their territory andthat the safety of the machinery concerned is,as far aspossible,improved in accordance with its provisions.Member States should ensure their capacity to carry outeffective market surveillance,taking account of guide-lines developed by the Commission,in order to achievethe proper and uniform application of this Directive.(11)In the context of market surveillance,a clear distinctionshould be established between the disputing of a harmo-nised standard conferring a presumption of conformityon machinery and the safeguard clause relating tomachinery.(12)The putting into service of machinery within themeaning of this Directive can relate only to the use ofthe machinery itself for its intended purpose or for apurpose which can reasonably be foreseen.This doesnot preclude the laying down of conditions of useexternal to the machinery,provided that it is not therebymodified in a way not specified in this Directive.(13)It is also necessary to provide for an adequatemechanism allowing for the adoption of specificmeasures at Community level requiring Member Statesto prohibit or restrict the placing on the market ofcertain types of machinery presenting the same risks tothe health and safety of persons either due to shortcom-ings in the relevant harmonised standard(s)or by virtueof their technical characteristics,or to make suchmachinery subject to special conditions.In order toensure the appropriate assessment of the need for suchmeasures,they should be taken by the Commission,assisted by a committee,in the light of consultationswith the Member States and other interested parties.Since such measures are not directly applicable toeconomic operators,Member States should take allnecessary measures for their implementation.(14)The essential health and safety requirements should besatisfied in order to ensure that machinery is safe;theserequirements should be applied with discernment to takeaccount of the state of the art at the time of constructionand of technical and economic requirements.(15)Where the machinery may be used by a consumer,thatis to say,a non-professional operator,the manufacturershould take account of this in the design and construc-tion.The same applies where a machine is normallyused to provide a service to a consumer.(16)Although the requirements of this Directive do notapply to partly completed machinery in their entirety,itis nevertheless important that the free movement ofsuch machinery be guaranteed by means of a specificprocedure.(17)For trade fairs,exhibitions and such like,it should bepossible to exhibit machinery which does not satisfy therequirements of this Directive.However,interestedparties should be properly informed that the machinerydoes not conform and cannot be purchased in thatcondition.(18)This Directive defines only the essential health and safetyrequirements of general application,supplemented by anumber of more specific requirements for certain cate-gories of machinery.In order to help manufacturers toprove conformity to these essential requirements,and toallow inspection of conformity to the essential require-ments,it is desirable to have standards that are harmo-nised at Community level for the prevention of risksarising out of the design and construction of machinery.These standards are drawn up by private-law bodies andshould retain their non-binding status.(19)In view of the nature of the risks involved in the use ofmachinery covered by this Directive,procedures forassessing conformity to the essential health and safetyrequirements should be established.These proceduresshould be devised in the light of the extent of the dangerinherent in such machinery.Consequently,each categoryof machinery should have its appropriate procedure inconformity with Council Decision93/465/EEC of22July1993concerning the modules for the various phases ofthe conformity assessment procedures and the rules forthe affixing and use of the CE conformity marking,which are intended to be used in the technical harmoni-sation directives(2),taking account of the nature of the(20)Manufacturers should retain full responsibility for certi-fying the conformity of their machinery to the provi-sions of this Directive.Nevertheless,for certain types ofmachinery having a higher risk factor,a stricter certifica-tion procedure is desirable.(21)The CE marking should be fully recognised as being theonly marking which guarantees that machineryconforms to the requirements of this Directive.All othermarkings which are likely to mislead third parties as tothe meaning or the form of the CE marking,or both,should be prohibited.(22)In order to ensure the same quality for the CE markingand the manufacturer's mark,it is important that they beaffixed according to the same techniques.In order toavoid confusion between any CE markings which mightappear on certain components and the CE markingcorresponding to the machinery,it is important that thelatter marking be affixed alongside the name of theperson who has taken responsibility for it,namely themanufacturer or his authorised representative.(23)The manufacturer or his authorised representativeshould also ensure that a risk assessment is carried outfor the machinery which he wishes to place on themarket.For this purpose,he should determine which arethe essential health and safety requirements applicable tohis machinery and in respect of which he must takemeasures.(24)It is essential that,before drawing up the EC declarationof conformity,the manufacturer or his authorised repre-sentative established in the Community should prepare atechnical construction file.However,it is not essentialthat all documentation should be permanently availablein material form,but it must be possible to make itavailable on request.It need not include detailed plans ofsubassemblies used for the manufacture of machinery,unless knowledge of such plans is essential in order toascertain conformity with the essential health and safetyrequirements.(25)The addressees of any decision taken under this Directiveshould be informed of the reasons for such a decisionand of the legal remedies open to them.(26)Member States should provide for penalties applicable toinfringements of the provisions of this Directive.Thosepenalties should be effective,proportionateand dissuasive.with respect to those covered by Directive95/16/EC ofthe European Parliament and of the Council of29June1995on the approximation of the laws of the MemberStates relating to lifts(1).A redefinition of the scope ofthe latter Directive is thus deemed necessary.Direc-tive95/16/EC should therefore be amended accordingly.(28)Since the objective of this Directive,namely,to laydown the essential health and safety requirements inrelation to design and manufacture in order to improvethe safety of machinery placed on the market,cannot besufficiently achieved by the Member States and can bebetter achieved at Community level,the Communitymay adopt measures,in accordance with the principle ofsubsidiarity as set out in Article5of the Treaty.Inaccordance with the principle of proportionality,as setout in that Article,this Directive does not go beyondwhat is necessary in order to achieve that objective.(29)In accordance with point34of the InterinstitutionalAgreement on better law-making(2),Member States areencouraged to draw up,for themselves and in the inter-ests of the Community,their own tables illustrating,asfar as possible,the correlation between this Directiveand the transposition measures,and to make thempublic.(30)The measures necessary for the implementation of thisDirective should be adopted in accordance with CouncilDecision1999/468/EC of28June1999laying downthe procedures for the exercise of implementing powersconferred on the Commission(3),HAS ADOPTED THIS DIRECTIVE:Article1Scope1.This Directive applies to the following products:(a)machinery;(b)interchangeable equipment;(c)safety components;(d)lifting accessories;(e)chains,ropes and webbing;(f)removable mechanical transmission devices;(g)partly completed machinery.(1)OJ L213,7.9.1995,p.1.Directive as amended by Regulation(EC)2.The following are excluded from the scope of this Direc-tive:(a)safety components intended to be used as spare parts toreplace identical components and supplied by the manufac-turer of the original machinery;(b)specific equipment for use in fairgrounds and/or amuse-ment parks;(c)machinery specially designed or put into service for nuclearpurposes which,in the event of failure,may result in an emission of radioactivity;(d)weapons,including firearms;(e)the following means of transport:—agricultural and forestry tractors for the risks covered by Directive2003/37/EC,with the exclusion ofmachinery mounted on these vehicles,—motor vehicles and their trailers covered by Council Directive70/156/EEC of6February1970on theapproximation of the laws of the Member Statesrelating to the type-approval of motor vehicles andtheir trailers(1),with the exclusion of machinerymounted on these vehicles,—vehicles covered by Directive2002/24/EC of the Euro-pean Parliament and of the Council of18March2002relating to the type-approval of two or three-wheelmotor vehicles(2),with the exclusion of machinerymounted on these vehicles,—motor vehicles exclusively intended for competition, and—means of transport by air,on water and on rail networks with the exclusion of machinery mounted onthese means of transport;(f)seagoing vessels and mobile offshore units and machineryinstalled on board such vessels and/or units;(g)machinery specially designed and constructed for militaryor police purposes;(h)machinery specially designed and constructed for researchpurposes for temporary use in laboratories;(i)mine winding gear;(j)machinery intended to move performers during artistic performances;(k)electrical and electronic products falling within the following areas,insofar as they are covered by Council Directive73/23/EEC of19February1973on the harmoni-sation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits(3):—household appliances intended for domestic use,—audio and video equipment,—information technology equipment,—ordinary office machinery,—low-voltage switchgear and control gear,—electric motors;(l)the following types of high-voltage electrical equipment:—switch gear and control gear,—transformers.Article2DefinitionsFor the purposes of this Directive,‘machinery’designates the products listed in Article1(1)(a)to(f).The following definitions shall apply:(a)‘machinery’means:—an assembly,fitted with or intended to be fitted with a drive system other than directly applied human oranimal effort,consisting of linked parts or components,at least one of which moves,and which are joinedtogether for a specific application,—an assembly referred to in the first indent,missing only the components to connect it on site or to sources ofenergy and motion,—an assembly referred to in the first and second indents, ready to be installed and able to function as it standsonly if mounted on a means of transport,or installed ina building or a structure,—assemblies of machinery referred to in the first,second and third indents or partly completed machineryreferred to in point(g)which,in order to achieve thesame end,are arranged and controlled so that theyfunction as an integral whole,—an assembly of linked parts or components,at least one of which moves and which are joined together,intended for lifting loads and whose only power sourceis directly applied human effort;(1)OJ L42,23.2.1970,p.1.Directive as last amended by Commission(b)‘interchangeable equipment’means a device which,afterthe putting into service of machinery or of a tractor,is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function,in so far as this equipment is not a tool;(c)‘safety component’means a component:—which serves to fulfil a safety function,—which is independently placed on the market,—the failure and/or malfunction of which endangers the safety of persons,and—which is not necessary in order for the machinery to function,or for which normal components may besubstituted in order for the machinery to function.An indicative list of safety components is set out in Annex V,which may be updated in accordance with Article8(1)(a);(d)‘lifting accessory’means a component or equipment notattached to the lifting machinery,allowing the load to be held,which is placed between the machinery and the load or on the load itself,or which is intended to constitute an integral part of the load and which is independently placed on the market;slings and their components are also regarded as lifting accessories;(e)‘chains,ropes and webbing’means chains,ropes andwebbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;(f)‘removable mechanical transmission device’means a remo-vable component for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing.When it is placed on the market with the guard it shall be regarded as one product;(g)‘partly completed machinery’means an assembly which isalmost machinery but which cannot in itself perform a specific application.A drive system is partly completed machinery.Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment,thereby forming machinery to which this Directive applies;(h)‘placing on the market’means making available for the firsttime in the Community machinery or partly completed machinery with a view to distribution or use,whether for reward or free of charge;(i)‘manufacturer’means any natural or legal person whopartly completed machinery with this Directive with a view to its being placed on the market,under his own name or trademark or for his own use.In the absence of a manufac-turer as defined above,any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer;(j)‘authorised representative’means any natural or legal person established in the Community who has received a written mandate from the manufacturer to perform on his behalf all or part of the obligations and formalities connected with this Directive;(k)‘putting into service’means the first use,for its intended purpose,in the Community,of machinery covered by this Directive;(l)‘harmonised standard’means a non-binding technical speci-fication adopted by a standardisation body,namely the European Committee for Standardisation(CEN),the Euro-pean Committee for Electrotechnical Standardisation (CENELEC)or the European Telecommunications Standards Institute(ETSI),on the basis of a remit issued by the Commission in accordance with the procedures laid down in Directive98/34/EC of the European Parliament and of the Council of22June1998laying down a procedure for the provision of information in the field of technical stan-dards and regulations and of rules on Information Society services(1).Article3Specific DirectivesWhere,for machinery,the hazards referred to in Annex I are wholly or partly covered more specifically by other Community Directives,this Directive shall not apply,or shall cease to apply,to that machinery in respect of such hazards from the date of implementation of those other Directives.Article4Market surveillance1.Member States shall take all appropriate measures to ensure that machinery may be placed on the market and/or put into service only if it satisfies the relevant provisions of this Directive and does not endanger the health and safety of persons and,where appropriate,domestic animals or property, when properly installed and maintained and used for its intended purpose or under conditions which can reasonably be foreseen.2.Member States shall take all appropriate measures to ensure that partly completed machinery can be placed on the market only if it satisfies the relevant provisions of this Direc-tive.3.Member States shall institute or appoint the competent authorities to monitor the conformity of machinery and partly completed machinery with the provisions set out in para-graphs1and2.4.Member States shall define the tasks,organisation and powers of the competent authorities referred to in paragraph3 and shall notify the Commission and other Member States thereof and also of any subsequent amendment.Article5Placing on the market and putting into service1.Before placing machinery on the market and/or putting it into service,the manufacturer or his authorised representative shall:(a)ensure that it satisfies the relevant essential health andsafety requirements set out in Annex I;(b)ensure that the technical file referred to in Annex VII,part A is available;(c)provide,in particular,the necessary information,such asinstructions;(d)carry out the appropriate procedures for assessing confor-mity in accordance with Article12;(e)draw up the EC declaration of conformity in accordancewith Annex II,part1,Section A and ensure that it accom-panies the machinery;(f)affix the CE marking in accordance with Article16.2.Before placing partly completed machinery on the market,the manufacturer or his authorised representative shall ensure that the procedure referred to in Article13has been completed.3.For the purposes of the procedures referred to in Article12,the manufacturer or his authorised representative shall have,or shall have access to,the necessary means of ensuring that the machinery satisfies the essential health and safety requirements set out in Annex I.4.Where machinery is also the subject of other Directives relating to other aspects and providing for the affixing of the CE marking,the marking shall indicate that the machinery also conforms to the provisions of those other Directives.a transitional period,the system to be applied,the CE marking shall indicate conformity only to the provisions of those Direc-tives applied by the manufacturer or his authorised representa-tive.Particulars of the Directives applied,as published in the Official Journal of the European Union,shall be given on the EC declaration of conformity.Article6Freedom of movement1.Member States shall not prohibit,restrict or impede the placing on the market and/or putting into service in their terri-tory of machinery which complies with this Directive.2.Member States shall not prohibit,restrict or impede the placing on the market of partly completed machinery where the manufacturer or his authorised representative makes a declaration of incorporation,referred to in Annex II,part1, Section B,stating that it is to be incorporated into machinery or assembled with other partly completed machinery to form machinery.3.At trade fairs,exhibitions,demonstrations,and such like, Member States shall not prevent the showing of machinery or partly completed machinery which does not conform to this Directive,provided that a visible sign clearly indicates that it does not conform and that it will not be made available until it has been brought into conformity.Furthermore,during demon-strations of such non-conforming machinery or partly completed machinery,adequate safety measures shall be taken to ensure the protection of persons.Article7Presumption of conformity and harmonised standards1.Member States shall regard machinery bearing the CE marking and accompanied by the EC declaration of conformity, the content of which is set out in Annex II,part1,Section A, as complying with the provisions of this Directive.2.Machinery manufactured in conformity with a harmo-nised standard,the references to which have been published in the Official Journal of the European Union,shall be presumed to comply with the essential health and safety requirements covered by such a harmonised standard.3.The Commission shall publish in the Official Journal of the European Union the references of the harmonised standards.4.Member States shall take the appropriate measures toArticle8Specific measures1.The Commission,acting in accordance with the proce-dure referred to in Article22(3),may take any appropriate measure to implement the provisions relating to the following points:(a)updating of the indicative list of safety components inAnnex V referred to in point(c)in Article2;(b)restriction of the placing on the market of machineryreferred to in Article9.2.The Commission,acting in accordance with the proce-dure referred to in Article22(2),may take any appropriate measure connected with the implementation and practical application of this Directive,including measures necessary to ensure cooperation of Member States with each other and with the Commission,as provided for in Article19(1).Article9Specific measures to deal with potentially hazardousmachinery1.When,in accordance with the procedure referred to in Article10,the Commission considers that a harmonised stand-ard does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex I, the Commission may,in accordance with paragraph3of this Article,take measures requiring Member States to prohibit or restrict the placing on the market of machinery with technical characteristics presenting risks due to the shortcomings in the standard or to make such machinery subject to special condi-tions.When,in accordance with the procedure referred to in Article11,the Commission considers that a measure taken by a Member State is justified,the Commission may,in accordance with paragraph3of this Article,take measures requiring Member States to prohibit or restrict the placing on the market of machinery presenting the same risk by virtue of its technical characteristics or to make such machinery subject to special conditions.2.Any Member State may request the Commission to examine the need for the adoption of the measures referred to in paragraph1.3.In the cases referred to in paragraph1,the Commission shall consult the Member States and other interested parties Taking due account of the results of this consultation,it shall adopt the necessary measures in accordance with the procedure referred to in Article22(3).Article10Procedure for disputing a harmonised standardWhere a Member State or the Commission considers that a harmonised standard does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex I,the Commission or the Member State shall bring the matter before the committee set up by Directive98/ 34/EC,setting out the reasons therefor.The committee shall deliver an opinion without delay.In the light of the commit-tee's opinion,the Commission shall decide to publish,not to publish,to publish with restriction,to maintain,to maintain with restriction or to withdraw the references to the harmo-nised standard concerned in the Official Journal of the European Union.Article11Safeguard clause1.Where a Member State ascertains that machinery covered by this Directive,bearing the CE marking,accompanied by the EC declaration of conformity and used in accordance with its intended purpose or under conditions which can reasonably be foreseen,is liable to compromise the health and safety of persons and,where appropriate,domestic animals or property, it shall take all appropriate measures to withdraw such machinery from the market,to prohibit the placing on the market and/or putting into service of such machinery or to restrict free movement thereof.2.The Member State shall immediately inform the Commis-sion and the other Member States of any such measure,indi-cating the reasons for its decision and,in particular,whether the non-conformity is due to:(a)failure to satisfy the essential requirements referred to inArticle5(1)(a);(b)incorrect application of the harmonised standards referredto in Article7(2);(c)shortcomings in the harmonised standards themselvesreferred to in Article7(2).3.The Commission shall enter into consultation with the parties concerned without delay.The Commission shall consider,after this consultation,whether or not the measures taken by the Member State are justified,。
DIRECTIVE 2001-81-EC
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
(3)
Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission (1), Having regard to the Opinion of the Economic and Social Committee (2),
(5)
The general approach and strategy of the Fifth Environmental Action Programme was approved by the Resolution of 1 February 1993 of the Council and the Representatives of the Governments of the Member States meeting within the Council on a Community programme of policy and action in relation to the environment and sustainable development (5) and it sets as objectives that critical loads and levels for acidification in the Community are not to be exceeded. The programme requires that all people should be effectively protected against health risks from air pollution and that permitted levels of pollution should take account of the protection of the environment. The programme also requires that guideline values from the World Health Organisation (WHO) should become mandatory at Community level. The Member States have signed the Gothenburg Protocol of 1 December 1999 to the United Nations Economic Commission for Europe (UNECE) Convention on long-range transboundary air pollution to abate acidification, eutrophication and ground-level ozone.
(CE认证用)欧盟体外诊断医疗器械指令 IVDD Directive 98_79_EC (2009年最新修订版-包括了所有的修订)
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents►B DIRECTIVE98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof27October1998on in vitro diagnostic medical devices(OJ L331,7.12.1998,p.1)Amended by:Official JournalNo page dateL284131.10.2003►M1Regulation(EC)No1882/2003of the European Parliament and of theCouncil of29September2003L1881418.7.2009►M2Regulation(EC)No596/2009of the European Parliament and of theCouncil of18June2009Corrected by:►C1Corrigendum,OJ L22,29.1.1999,p.75(98/79/EC)►C2Corrigendum,OJ L6,10.1.2002,p.70(98/79/EC)DIRECTIVE98/79/EC OF THE EUROPEAN PARLIAMENTAND OF THE COUNCILof27October1998on in vitro diagnostic medical devicesTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community,and in particular Article100a thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article189b of the Treaty(3),(1)Whereas measures should be adopted for the smooth operation ofthe internal market;whereas the internal market is an area without internal frontiers in which the free movement of goods, persons,services and capital is ensured;(2)Whereas the content and scope of the laws,regulations andadministrative provisions in force in the Member States with regard to the safety,health protection and performance,charac-teristics and authorisation procedures for in vitro diagnostic medical devices are different;whereas the existence of such disparities creates barriers to trade,and whereas the need to establish harmonised rules has been confirmed by a comparative survey of national legislations carried out on behalf of the Commission;(3)Whereas the harmonisation of national legislation is the onlymeans of removing such barriers to free trade and of preventing new barriers from arising;whereas this objective cannot be achieved in a satisfactory manner by other means by the indi-vidual Member States;whereas this Directive lays down only such requirements as are necessary and sufficient to ensure, under the best safety conditions,free movement of the in vitro diagnostic medical devices to which it applies;(4)Whereas the harmonised provisions must be distinguished frommeasures adopted by the Member States to manage the funding of public health and sickness insurance schemes relating directly or indirectly to such devices;whereas,therefore,the harmonised provisions do not affect the ability of the Member States to implement such measures provided that they comply with Community law;(5)Whereas in vitro diagnostic medical devices should providepatients,users and third parties with a high level of health protection and attain the performance levels originally attributed to them by the manufacturer;whereas,therefore,maintenance or improvement of the level of health protection attained in the Member States is one of the main objectives of this Directive;(6)Whereas,in accordance with the principles set out in the Councilresolution of7May1985on a new approach to technical harmo-nisation and standards(4),rules regarding the design,manufacture(1)OJ C172,7.7.1995,p.21and OJ C87,18.3.1997,p.9.(2)OJ C18,22.1.1996,p.12.(3)Opinion of the European Parliament of12March1996(OJ C96,1.4.1996,p.31),Council common position of23March1998(OJ C178,10.6.1998, p.7)and Decision of the European Parliament of18June1998(OJ C210,6.7.1998).Council Decision of5October1998.(4)OJ C136,4.6.1985,p.1.and packaging of relevant products must be confined to the provisions required to meet the essential requirements;whereas, because they are essential,such requirements should replace the corresponding national provisions;whereas the essential requirements,including requirements to minimise and reduce risks,should be applied with discretion,taking into account the technology and practice at the time of design and technical and economic considerations compatible with a high level of protection of health and safety;(7)Whereas the major part of medical devices are covered by CouncilDirective90/385/EEC of20June1990on the approximation of laws relating to active implantable medical devices(1)and Council Directive93/42/EEC of14June1993concerning medical devices(2)with the exclusion of in vitro diagnostic medical devices;whereas this Directive seeks to extend the harmo-nisation to in vitro diagnostic medical devices and whereas,in the interest of uniform Community rules,this Directive is based largely on the provisions of the said two Directives;(8)Whereas instruments,apparatus,appliances,materials or otherarticles,including software,which are intended to be used for research purposes,without any medical objective,are not regarded as devices for performance evaluation;(9)Whereas,although internationally certified reference materialsand materials used for external quality assessment schemes are not covered by this Directive,calibrators and control materials needed by the user to establish or verify performances of devices are in vitro diagnostic medical devices;(10)Whereas,having regard to the principle of subsidiarity,reagentswhich are produced within health-institution laboratories for use in that environment and are not subject to commercialtransactions are not covered by this Directive;(11)Whereas,however,devices that are manufactured and intended tobe used in a professional and commercial context for purposes of medical analysis without being marketed are subject to this Directive;(12)Whereas mechanical laboratory equipment especially designed forin vitro diagnostic examinations falls within the scope of this Directive and whereas,therefore,in order to harmonise the relevant directives,Directive98/37/EC of the European Parliament and of the Council of22June1998on the approx-imation of the laws of the Member States relating to machinery(3),should be appropriately amended to bring it into line with this Directive;(13)Whereas this Directive should include requirements regarding thedesign and manufacture of devices emitting ionizing radiation;whereas this Directive does not affect the application of Council Directive96/29/Euratom of13May1996laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation(4); (14)Whereas,since electromagnetic compatibility aspects form anintegral part of the essential requirements of this Directive, Council Directive89/336/EEC of2May1989on the approxi-mation of the laws of the Member States relating to electro-magnetic compatibility(5)does not apply;(1)OJ L189,20.7.1990,p.17.Directive as last amended by Directive93/68/EEC(OJ L220,30.8.1993,p.1).(2)OJ L169,12.7.1993,p.1.(3)OJ L207,23.7.1998,p.1.(4)OJ L159,29.6.1996,p.1.(5)OJ L139,23.5.1989,p.19.Directive as last amended by Directive93/68/EEC(OJ L220,30.8.1993,p.1).(15)Whereas,in order to ease the task of proving conformity with theessential requirements and to enable conformity to be verified,it is desirable to have harmonised standards in respect of the prevention of risks associated with the design,manufacture and packaging of medical devices;whereas such harmonised standards are drawn up by private-law bodies and should retain their status as non-mandatory texts;whereas,to this end,the European Committee for Standardisation(CEN)and the European Committee for Electrotechnical Standardisation (Cenelec)are recognised as the competent bodies for the adoption ofharmonised standards in accordance with the general guidelines on cooperation between the Commission and those two bodies signed on13November1984;(16)Whereas,for the purpose of this Directive,a harmonised standardis a technical specification(European standard of harmonisation document)adopted,on a mandate from the Commission,by CEN or Cenelec or by both of those bodies in accordance with Directive98/34/EC of the European Parliament and of the Council of22June1998laying down a procedure for the provision of information in the field of technical standards and regulations(1),and pursuant to the abovementioned general guidelines;(17)Whereas,by way of exception to the general principles,thedrawing up of common technical specifications takes account of a current practice in some Member States whereby for selected devices mainly used for the evaluation of the safety of blood supply and of organ donation,such specifications are adopted by the public authorities;whereas it is appropriate that these particular specifications should be replaced by common technical specifications;whereas these common technical specifi-cations can be used for performance evaluation and reevaluation;(18)Whereas scientific experts from various interested parties couldbe involved in the drafting of common technical specifications and in the examination of other specific or general questions; (19)Whereas manufacturing,as covered by this Directive,alsoincludes the packaging of the medical device,insofar as such packaging is related to the safety and performance aspects of this device;(20)Whereas certain devices have a limited life owing to the declinein their performance over time,which is related,for example,to the deterioriation in their physical or chemical properties, including the sterility or integrity of the packaging;whereas the manufacturer should determine and indicate the period during which the device will perform as intended;whereas the labelling should indicate the date until which the device or one of its components can be used with complete safety;(21)Whereas,in Decision93/465/EEC of22July1993concerningthe modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking,which are intended to be used in the technical harmonisation directives(2),the Council laid down harmonised conformity assessment procedures;whereas the details added to these modules are justified by the nature of the verification required for in vitro diagnostic medical devices and by the need for consistency with Directives90/385/EEC and 93/42/EEC;(22)Whereas it is necessary,essentially for the purpose of theconformity assessment procedures,to group in vitro diagnostic(1)OJ L204,21.7.1998,p.37.Directive as last amended by Directive98/48/EC(OJ L217,5.8.1998,p.18).(2)OJ L220,30.8.1993,p.23.medical devices into two main product classes;whereas,since the large majority of such devices do not constitute a direct risk to patients and are used by competently trained professionals,and the results obtained can often be confirmed by other means,the conformity assessment procedures can be carried out,as a general rule,under the sole responsibility of the manufacturer;whereas, taking account of existing national regulations and of notifi-cations received following the procedure laid down in Directive 98/34/EC,the intervention of notified bodies is needed only for defined devices,the correct performance of which is essential to medical practice and the failure of which can cause a serious risk to health;(23)Whereas,among the in vitro diagnostic medical devices forwhich intervention of a notified body is required,the groups of products used in blood transfusion and the prevention of AIDS and certain types of hepatitis require a conformity assessment guaranteeing,with a view to their design and manufacture,an optimum level of safety and reliability;(24)Whereas the list of in vitro diagnostic medical devices to besubjected to third-party conformity assessment needs updating, taking account of technological progress and of developments in the field of health protection;whereas such updating measures must be taken in line with procedure III(a)as laid down in Council Decision87/373/EEC of13July1987laying down the procedures for the exercise of implementing powers conferred on the Commission(1);(25)Whereas an agreement on a modus vivendi between the EuropeanParliament,the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article189b of the Treaty was reached on20December1994(2);(26)Whereas medical devices should,as a general rule,bear the CEmarking indicating their conformity with the provisions of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose;(27)Whereas manufacturers will be able,when the intervention of anotified body is required,to choose from a list of bodies published by the Commission;whereas,although Member States do not have an obligation to designate such notified bodies,they must ensure that bodies designated as notified bodies comply with the assessment criteria laid down in this Directive;(28)Whereas the director and staff of the notified bodies should not,themselves or through an intermediary,have any interest in the establishments subject to assessment and verification which is likely to compromise their independence;(29)Whereas the competent authorities in charge of marketsurveillance should be able,particularly in emergencies,to contact the manufacturer or his authorised representative estab-lished in the Community,in order to take any protection measures that should prove necessary;whereas cooperation and exchange of information between Member States are necessary with a view to uniform application of this Directive,in particular for the purpose of market surveillance;whereas to that end it is necessary to establish and manage a database containing data on manufacturers and their authorised representatives,on devices placed on the market,on certificates issued,suspended or withdrawn,and on the vigilance procedure;whereas a system(1)OJ L197,18.7.1987,p.33.(2)OJ C102,4.4.1996,p.1.of adverse incident reporting(vigilance procedure)constitutes a useful tool for surveillance of the market,including the performance of new devices;whereas information obtained from the vigilance procedure as well as from external quality assessment schemes is useful for decision-making on classifi-cation of devices;(30)Whereas it is essential that manufacturers notify the competentauthorities of the placing on the market of‘new products’with regard both to the technology used and the substances to be analysed or other parameters;whereas this is true in particular of high-density DNA probe devices(known as micro-chips)used in genetic screening;(31)Whereas,when a Member State considers that,as regards a givenproduct or group of products,it is necessary,in order to protect health and safety and/or ensure compliance with the imperatives of public health,in accordance with Article36of the Treaty,to prohibit or restrict their availability or to subject it to special conditions,it may take any transitional measures that are necessary and justified;whereas,in such cases,the Commission consults the interested parties and the Member States and,if the national measures are justified,adopts the necessary Community measures,in accordance with procedure III(a)as laid down in Decision87/373/EEC;(32)Whereas this Directive covers in vitro diagnostic medical devicesmanufactured from tissues,cells or substances of human origin;whereas it does not refer to the other medical devices manu-factured using substances of human origin;whereas,therefore, work will have to continue in this connection in order to produce Community legislation as soon as possible;(33)Whereas,in view of the need to protect the integrity of thehuman person during the sampling,collection and use of substances derived from the human body,it is appropriate to apply the principles laid down in the Convention of the Council of Europe for the protection of human rights and dignity of the human being with regard to the application of biology and medicine;whereas,furthermore,national regulations relating to ethics continue to apply;(34)Whereas,in the interests of overall consistency betweendirectives on medical devices,some of the provisions of this Directive should be incorporated into Directive93/42/EEC, which needs to be amended accordingly;(35)Whereas it is necessary to draw up as quickly as possible thelegislation which is lacking on medical devices manufactured using substances of human origin,HAVE ADOPTED THIS DIRECTIVE:Article1Scope,definitions1.This Directive shall apply to in vitro diagnostic medical devices and their accessories.For the purposes of this Directive,accessories shall be treated as in vitro diagnostic medical devices in their own right.Both in vitro diagnostic medical devices and accessories shall hereinafter be termed devices.2.For the purposes of this Directive,the following definitions shall apply:(a)‘medical device’means any instrument,apparatus,appliance,material or other article,whether used alone or in combination,including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:—diagnosis,prevention,monitoring,treatment or alleviation of disease,—diagnosis,monitoring,treatment,alleviation or compensation for an injury or handicap,—investigation,replacement or modification of the anatomy or of a physiological process,—control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological,immunological or metabolic means,but which may be assisted in its function by such means;(b)‘in vitro diagnostic medical device’means any medical devicewhich is a reagent,reagent product,calibrator,control material, kit,instrument,apparatus,equipment,or system,whether used alone or in combination,intended by the manufacturer to be used in vitro for the examination of specimens,including blood and tissue donations,derived from the human body,solely or principally for the purpose of providing information:—concerning a physiological or pathological state,or—concerning a congenital abnormality,or—to determine the safety and compatibility with potential reci-pients,or—to monitor therapeutic measures.Specimen receptacles are considered to be in vitro diagnostic medical devices.‘Specimen receptacles’are those devices, whether vacuum-type or not,specifically intended by their manu-facturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.Products for general laboratory use are not in vitro diagnostic medical devices unless such products,in view of their character-istics,are specifically intended by their manufacturer to be used for in vitro diagnostic examination;(c)‘accessory’means an article which,whilst not being an in vitrodiagnostic medical device,is intended specifically by its manu-facturer to be used together with a device to enable that device to be used in accordance with its intended purpose.For the purposes of this definition,invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive93/42/EEC shall not be considered to be accessories to in vitro diagnostic medical devices;(d)‘device for self-testing’means any device intended by the manu-facturer to be able to be used by lay persons in a home envir-onment;(e)‘device for performance evaluation’means any device intendedby the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises;(f)‘manufacturer’means the natural or legal person with responsi-bility for the design,manufacture,packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles,packages, processes,fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own name.This subparagraph does not apply to the person who,while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devicesalready on the market to their intended purpose for an individual patient;(g)‘authorised representative’means any natural or legal personestablished in the Community who,explicitly designated by the manufacturer,acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;(h)‘intended purpose’means the use for which the device isintended according to the data supplied by the manufacturer on the labelling,in the instructions for use and/or in promotional materials;(i)‘placing on the market’means the first making available in returnfor payment or free of charge of a device other than a device intended for performance evaluation with a view to distribution and/or use on the Community market,regardless of whether it is new or fully refurbished;(j)‘putting into service’means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose.3.For the purposes of this Directive,calibration and control materials refer to any substance,material or article intended by their manufacturer either to establish measurement relationships or to verify the performance characteristics of a device in conjunction with the intended use of that device.4.For the purposes of this Directive,the removal,collection and use of tissues,cells and substances of human origin shall be governed,in relation to ethics,by the principles laid down in the Convention of the Council of Europe for the protection of human rights and dignity of the human being with regard to the application of biology and medicine and by any Member States regulations on this matter.5.This Directive shall not apply to devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity.This does not affect the right of Member State to subject such activities to appropriate protection requirements.6.This Directive shall not affect national laws which provide for the supply of devices by a medical prescription.7.This Directive is a specific directive within the meaning of Article2(2)of Directive89/336/EEC,which shall cease to apply to devices which have complied with this Directive.Article2Placing on the market and putting into service Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed,maintained and used in accordance with their intended purpose.This involves the obligation of Member States to monitor the security and quality of these devices.This Article applies also to devices made available for performance evaluation.Article3Essential requirementsDevices must meet the essential requirements set out in Annex I which apply to them,taking account of the intended purpose of the devices concerned.Article4Free movement1.Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article16if these devices have undergone conformity assessment in accordance with Article9.2.Member States shall not create any obstacle to devices intended for performance evaluation being made available for that purpose to the laboratories or other institutions listed in the statement referred to in Annex VIII if they meet the conditions laid down in Article9(4)and Annex VIII.3.At trade fairs,exhibitions,demonstrations,scientific or technical gatherings,etc.Member States shall not create any obstacle to the showing of devices which do not conform to this Directive,provided that such devices are not used on specimens taken from the participants and that a visible sign clearly indicates that such devicescannot be marketed or put into service until they have been made to comply.4.Member States may require the information to be supplied pursuant to Annex I,part B,section8to be in their official language (s)when a device reaches the final user.Provided that safe and correct use of the device is ensured,Member States may authorise the information referred to in the first subpar-agraph to be in one or more other official Community language(s).In the application of this provision,Member States shall take into account the principle of proportionality and,in particular:(a)whether the information can be supplied by harmonised symbols orrecognised codes or other measures;(b)the type of user anticipated for the device.5.Where the devices are subject to other directives concerning other aspects which also provide for the affixing of the CE marking,the latter shall indicate that the devices also fulfil the provisions of the other directives.However,should one or more of these directives allow the manu-facturer,during a transitional period,to choose which arrangements to apply,the CE marking shall indicate that the devices fulfil the provisions only of those directives applied by the manufacturer.In this case,the particulars of these directives,as published in the Official Journal of the European Communities,must be given in the documents,notices or instructions required by the directives and accom-panying such devices.Article5Reference to standards1.Member States shall presume compliance with the essential requirements referred to in Article3in respect of devices which are in conformity with the relevant national standards transposing the harmonised standards the reference numbers of which have been published in the Official Journal of the European Communities;Member States shall publish the reference numbers of such nationalstandards.2.If a Member State or the Commission considers that theharmonised standards do not entirely meet the essential requirementsreferred to in Article3,the measures to be taken by the MemberStates with regard to these standards and the publication referred to inparagraph1of this Article shall be adopted by the procedure defined inArticle6(2).3.Member States shall presume compliance with the essentialrequirements referred to in Article3in respect of devices designedand manufactured in conformity with common technical specificationsdrawn up for the devices in List A of Annex II and,where necessary,the devices in List B of Annex II.These specifications shall establishappropriate performance evaluation and re-evaluation criteria,batchrelease criteria,reference methods and reference materials.The common technical specifications shall be adopted in accordancewith the procedure mentioned in Article7(2)and be published in theOfficial Journal of the European Communities.Manufacturers shall as a general rule be required to comply with thecommon technical specifications;if for duly justified reasons manufac-turers do not comply with those specifications they must adopt solutionsof a level at least equivalent thereto.Where,in this Directive,reference is made to harmonised standards,thisis also meant to refer to the common technical specifications.▼M1Article6Committee on Standards and Technical Regulations1.The Commission shall be assisted by the Committee set up byArticle5of Directive98/34/EC(hereinafter referred to as‘theCommittee’).2.Where reference is made to this Article,Articles3and7ofDecision1999/468/EC(1)shall apply,having regard to the provisionsof Article8thereof.3.The Committee shall adopt its rules of procedure.▼M2Article71.The Commission shall be assisted by the Committee set up byArticle6(2)of Directive90/385/EEC.2.Where reference is made to this paragraph,Articles5and7ofCouncil Decision1999/468/EC(2)shall apply,having regard to theprovisions of Article8thereof.The period laid down in Article5(6)of Decision1999/468/EC shall beset at three months.3.Where reference is made to this paragraph,Article5a(1)to(4)andArticle7of Decision1999/468/EC shall apply,having regard to theprovisions of Article8thereof.4.Where reference is made to this paragraph,Article5a(1),(2),(4)and(6)and Article7of Decision1999/468/EC shall apply,havingregard to the provisions of Article8thereof.(1)Council Decision1999/468/EC of28June1999laying down the proceduresfor the exercise of implementing powers conferred on the Commission(OJL184,17.7.1999,p.23).(2)OJ L184,17.7.1999,p.23.。
伍德沃德 GS16 配备 On-board 驱动的气体阀 产品规格 03284 (Rev. F)说明
the gas valve in response to the 4–20 mA or DeviceNet input command signal • Actual valve position feedback via 4–20 mA or DeviceNet • Independent remote shutdown input • Valve/Driver fault output
All faults indications are available through the DeviceNet connection or through an RS-232 connection when using an analog control interface.
FUEL FLOW
The GS16 is an electrically actuated fuel valve with an on-board electronic position controller. Highly accurate flow control is achieved by the use of a spherical fuel metering element with a precision machined fuel metering port. A seal shoe
• Highly accurate fuel flow metering
• Single moving part for reliable performance
CE认证Machinery directive
机械指令的定义
a) 机械是指： - 已安装或计划安装于驱动系统，而非直接施加人力或兽力的总成件。 该驱动系统包含多个联结零件或组件、至少一个零件或组件运动，且 各零件或组件为特定用途而相互连接； - 上述第一项所称之总成件，但仅缺乏将其连接至现场或能量及动力源 的组件； - 上述第一或第二项所称之总成件，已准备好随时安装，且必须安装在 运输工具、建筑物或结构体才能发挥功能； - 上述第一、第二及第三项所称之机器总成件，或(g)项所称之部分完 成的机器，经安排或控制后可发挥整合功能，进而达成相同目的； - 联结零件或组件之总成件，其中至少有一个零件或组件进行动作、相 互连接以举升装载物，且以直接施加人力作为动力的来源 b) ―可互换的设备”系指一种装置，在机器或牵引机投入服务后，即由作 业员将其与该机器或牵引机组装在一起，以改变其功能或赋予其新的 功能。但若此设备为一种工具，即不使用此定义。
ቤተ መጻሕፍቲ ባይዱ
谢 谢
THANKS!
自我声明新要求
• Annex II 1.A.2 name and address of the person authorised to compile the technical file, who must be established in the Community; 欧盟授权人的姓名和地址 AVT不承认土耳其人作为欧盟授权代表
98_37_EC
NOTICES FROM MEMBER STATESCommission communication in the framework of the implementation of the Directive98/37/EC of the European Parliament and of the Council on the approximation of the laws of the Member Statesrelating to machinery(Text with EEA relevance)(Publication of titles and references of harmonised standards under the directive)(2009/C74/03)ESO(1)Reference and title of the harmonised standard(and reference document)First publicationOJReference of supersededstandardDate of cessationof presumptionof conformity ofsupersededstandard(Note1)CEN EN81-3:2000+A1:2008Safety rules for the construction and installation of lifts—Part3:Electricand hydraulic service lifts28.1.2009EN81-3:200028.12.2009CEN EN81-40:2008Safety rules for the construction and installation of lifts—Special liftsfor the transport of persons and goods—Part40:Stairlifts and inclinedlifting platforms intended for persons with impaired mobility This is the firstpublication—CEN EN115-1:2008Safety of escalators and moving walks—Part1:Construction and instal-lation28.1.2009EN115:199528.12.2009CEN EN201:1997Rubber and plastics machines—Injection moulding machines—Safetyrequirements4.6.1997—EN201:1997/A1:200020.5.2000Note3Date expired(31.8.2000)EN201:1997/A2:200531.12.2005Note3Date expired(31.1.2006)CEN EN280:2001Mobile elevating work platforms—Design calculations—Stabilitycriteria—Construction—Safety—Examinations and tests14.6.2002—EN280:2001/A1:2004 2.8.2006Note3Date expired(2.8.2006)CEN EN289:2004+A1:2008Plastics and rubber machines—Presses—Safety requirements28.1.2009EN289:200428.12.2009CEN EN349:1993+A1:2008Safety of machinery—Minimum gaps to avoid crushing of parts of thehuman body 22.8.2008EN349:199328.12.2009ESO(1)Reference and title of the harmonised standard(and reference document)First publicationOJReference of supersededstandardof presumptionof conformity ofsupersededstandard(Note1)CEN EN378-2:2008Refrigerating systems and heat pumps—Safety and environmentalrequirements—Part2:Design,construction,testing,marking and docu-mentation22.8.2008—CEN EN415-1:2000Packaging machines safety—Part1:Terminology and classification ofpackaging machines and associated equipment14.6.2002—CEN EN415-2:1999Packaging machines safety—Part2:Pre-formed rigid container packa-ging machines20.5.2000—CEN EN415-3:1999Safety of packaging machines—Part3:Form,fill and seal machines27.11.2001—CEN EN415-4:1997Safety of packaging machines—Part4:Palletisers and depalletisers4.6.1997—CEN EN415-5:2006Safety of packaging machines—Wrapping machines8.5.2007—CEN EN415-6:2006Safety of packaging machines—Part6:Pallet wrapping machines8.5.2007—CEN EN415-7:2006+A1:2008Safety of packaging machines—Part7:Group and secondary packagingmachines28.1.2009EN415-7:200628.12.2009CEN EN415-8:2008Safety of packaging machines—Part8:Strapping machines24.6.2008—CEN EN422:1995Rubber and plastics machines—Safety—Blow moulding machinesintended for the production of hollow articles—Requirements for thedesign and construction8.8.1996—CEN EN453:2000Food processing machinery—Dough mixers—Safety and hygienerequirements10.3.2001—CEN EN454:2000Food processing machinery—Planetary mixers—Safety and hygienerequirements10.3.2001—CEN EN474-1:2006Earth-moving machinery—Safety—Part1:General requirements 8.5.2007EN474-1:1994Date expired(30.11.2008)CEN EN474-2:2006+A1:2008Earth-moving machinery—Safety—Part2:Requirements for tractor-dozers This is the firstpublicationEN474-2:200628.12.2009CEN EN474-3:2006Earth-moving machinery—Safety—Part3:Requirements for loaders 8.5.2007EN474-3:1996Date expired(30.11.2008)ESO(1)Reference and title of the harmonised standard(and reference document)First publicationOJReference of supersededstandardof presumptionof conformity ofsupersededstandard(Note1)CEN EN474-4:1996Earth-moving machinery—Safety—Part4:Requirements for backhoeloaders15.10.1996—CEN EN474-5:1996Earth-moving machinery—Safety—Part5:Requirements for hydraulicexcavators15.10.1996—EN474-5:1996/AC:1997CEN EN474-6:2006Earth-moving machinery—Safety—Part6:Requirements for dumpers 8.5.2007EN474-6:1996Date expired(30.11.2008)CEN EN474-7:2006Earth-moving machinery—Safety—Part7:Requirements for scrapers 8.5.2007EN474-7:1998Date expired(30.11.2008)CEN EN474-8:2006Earth-moving machinery—Safety—Part8:Requirements for graders 8.5.2007EN474-8:1998Date expired(30.11.2008)CEN EN474-9:2006Earth-moving machinery—Safety—Part9:Requirements for pipelayers 8.5.2007EN474-9:1998Date expired(30.11.2008)CEN EN474-10:2006Earth-moving machinery—Safety—Part10:Requirements for tren-chers 8.5.2007EN474-10:1998Date expired(30.11.2008)CEN EN474-11:2006+A1:2008Earth-moving machinery—Safety—Part11:Requirements for earthand landfill compactors This is the firstpublicationEN474-11:200628.12.2009CEN EN474-12:2006+A1:2008Earth-moving machinery—Safety—Part12:Requirements for cableexcavators This is the firstpublicationEN474-12:200628.12.2009CEN EN500-1:2006Mobile road construction machinery—Safety—Part1:Commonrequirements 8.5.2007EN500-1:1995Date expired(30.11.2008)CEN EN500-2:2006+A1:2008Mobile road construction machinery—Safety—Part2:Specific require-ments for road-milling machines This is the firstpublicationEN500-2:200628.12.2009CEN EN500-3:2006+A1:2008Mobile road construction machinery—Safety—Part3:Specific require-ments for soil-stabilising machines and recycling machines This is the firstpublicationEN500-3:200628.12.2009CEN EN500-4:1995Mobile road construction machinery—Safety—Part4:Specific require-ments for compaction machines14.2.1996—CEN EN500-6:2006+A1:2008Mobile road construction machinery—Safety—Part6:Specific require-ments for paver-finishers This is the firstpublicationEN500-6:200628.12.2009CEN EN528:2008Rail dependent storage and retrieval equipment—Safety requirements This is the firstpublicationEN528:199631.12.2009ESO(1)Reference and title of the harmonised standard(and reference document)First publicationOJReference of supersededstandardof presumptionof conformity ofsupersededstandard(Note1)CEN EN536:1999Road construction machines—Asphalt mixing plants—Safety require-ments5.11.1999—CEN EN547-1:1996+A1:2008Safety of machinery—Human body measurements—Part1:Principlesfor determining the dimensions required for openings for whole bodyaccess into machinery28.1.2009EN547-1:199628.12.2009CEN EN547-2:1996+A1:2008Safety of machinery—Human body measurements—Part2:Principlesfor determining the dimensions required for access openings28.1.2009EN547-2:199628.12.2009CEN EN547-3:1996+A1:2008Safety of machinery—Human body measurements—Part3:Anthropo-metric data28.1.2009EN547-3:199628.12.2009CEN EN574:1996+A1:2008Safety of machinery—Two-hand control devices—Functional aspects—Principles for design22.8.2008EN574:199628.12.2009CEN EN609-1:1999Agricultural and forestry machinery—Safety of log splitters—Part1:Wedge splitters11.6.1999—EN609-1:1999/A1:200331.12.2005Note3Date expired(31.12.2005)CEN EN609-2:1999Agricultural and forestry machinery—Safety of log splitters—Part2:Screw splitter15.4.2000—CEN EN614-1:2006Safety of machinery—Ergonomic design principles—Part1:Termi-nology and general principles 8.5.2007EN614-1:1995Date expired(8.5.2007)CEN EN614-2:2000+A1:2008Safety of machinery—Ergonomic design principles—Part2:Interac-tions between the design of machinery and work tasks28.1.2009EN614-2:200028.12.2009CEN EN617:2001Continuous handling equipment and systems—Safety and EMC require-ments for the equipment for the storage of bulk materials in silos,bunkers,bins and hoppers14.6.2002—CEN EN618:2002Continuous handling equipment and systems—Safety and EMC require-ments for equipment for mechanical handling of bulk materials exceptfixed belt conveyors24.6.2003—CEN EN619:2002Continuous handling equipment and systems—Safety and EMC require-ments for equipment for mechanical handling of unit loads14.8.2003—CEN EN620:2002Continuous handling equipment and systems—Safety and EMC require-ments for fixed belt conveyors for bulk materials24.6.2003—ESO(1)Reference and title of the harmonised standard(and reference document)First publicationOJReference of supersededstandardof presumptionof conformity ofsupersededstandard(Note1)CEN EN626-1:1994+A1:2008Safety of machinery—Reduction of risks to health from hazardoussubstances emitted by machinery—Part1:Principles and specificationsfor machinery manufacturers28.1.2009EN626-1:199428.12.2009CEN EN626-2:1996+A1:2008Safety of machinery—Reduction of risk to health from hazardoussubstances emitted by machinery—Part2:Methodology leading to veri-fication procedures22.8.2008EN626-2:199628.12.2009CEN EN627:1995Specification for data logging and monitoring of lifts,escalators andpassenger conveyors28.11.1996—CEN EN632:1995Agricultural machinery—Combine harvesters and forage harvesters—Safety8.8.1996—CEN EN690:1994Agricultural machinery—Manure spreaders—Safety1.7.1995—CEN EN692:2005Machine tools—Mechanical presses—Safety 2.8.2006EN692:1996Date expired(2.8.2006)CEN EN693:2001Machine tools—Safety—Hydraulic presses27.11.2001—CEN EN703:2004Agricultural machinery—Silage loading,mixing and/or chopping anddistributing machines—Safety 31.12.2005EN703:1995Date expired(31.12.2005)CEN EN704:1999Agricultural machinery—Pick-up balers—Safety11.6.1999—CEN EN706:1996Agricultural machinery—Vine shoot tipping machines—Safety22.3.1997—CEN EN707:1999Agricultural machinery—Slurry tankers—Safety5.11.1999—CEN EN708:1996Agricultural machinery—Soil working machines with powered tools—Safety8.5.1997—EN708:1996/A1:200016.6.2000Note3Date expired(30.9.2000)CEN EN709:1997Agricultural and forestry machinery—Pedestrian controlled tractorswith mounted rotary cultivators,motor hoes,motor hoes with drivewheel(s)—Safety23.10.1997—EN709:1997/A1:199915.4.2000Note3Date expired(15.4.2000)CEN EN710:1997Safety requirements for foundry moulding and coremaking machineryand plant associated equipment13.3.1998—CEN EN741:2000Continuous handling equipment and systems—Safety requirements forsystems and their components for pneumatic handling of bulk materials27.11.2001—ESO(1)Reference and title of the harmonised standard(and reference document)First publicationOJReference of supersededstandardof presumptionof conformity ofsupersededstandard(Note1)CEN EN745:1999Agricultural machinery—Rotary mowers and flail-mowers—Safety11.6.1999—CEN EN746-1:1997Industrial thermoprocessing equipment—Part1:Common safetyrequirements for industrial thermoprocessing equipment4.6.1997—CEN EN746-2:1997Industrial thermoprocessing equipment—Part2:Safety requirements forcombustion and fuel handling systems4.6.1997—CEN EN746-3:1997Industrial thermoprocessing equipment—Part3:Safety requirements forthe generation and use of atmosphere gases4.6.1997—CEN EN746-4:2000Industrial thermoprocessing equipment—Part4:Particular safetyrequirements for hot dip galvanising thermoprocessing equipment16.6.2000—CEN EN746-5:2000Industrial thermoprocessing equipment—Part5:Particular safetyrequirements for salt bath thermoprocessing equipment27.11.2001—CEN EN746-8:2000Industrial thermoprocessing equipment—Part8:Particular safetyrequirements for quenching equipment27.11.2001—CEN EN774:1996Garden equipment—Hand held,integrally powered hedge trimmers—Safety15.10.1996—EN774:1996/A1:19978.5.1997Note3Date expired(31.8.1997)EN774:1996/A2:199723.10.1997Note3Date expired(31.12.1997)EN774:1996/A3:200127.11.2001Note3Date expired(27.11.2001)CEN EN786:1996Garden equipment—Electrically powered walk-behind and hand-heldlawn trimmers and lawn edge trimmers—Mechanical safety15.10.1996—EN786:1996/A1:200127.11.2001Note3Date expired(27.11.2001)EN786:1996/AC:1996CEN EN791:1995Drill rigs—Safety8.8.1996—CEN EN792-1:2000+A1:2008Hand-held non-electric power tools—Safety requirements—Part1:Assembly power tools for non-threaded mechanical fasteners28.1.2009EN792-1:200028.12.2009CEN EN792-2:2000+A1:2008Hand-held non-electric power tools—Safety requirements—Part2:Cutting-off and crimping power tools28.1.2009EN792-2:200028.12.2009ESO(1)Reference and title of the harmonised standard(and reference document)First publicationOJReference of supersededstandardof presumptionof conformity ofsupersededstandard(Note1)CEN EN792-3:2000+A1:2008Hand-held non-electric power tools—Safety requirements—Part3:Drills and tappers28.1.2009EN792-3:200028.12.2009CEN EN792-4:2000+A1:2008Hand-held non-electric power tools—Safety requirements—Part4:Non-rotary percussive power tools28.1.2009EN792-4:200028.12.2009CEN EN792-5:2000+A1:2008Hand-held non-electric power tools—Safety requirements—Part5:Rotary percussive drills28.1.2009EN792-5:200028.12.2009CEN EN792-6:2000+A1:2008Hand-held non-electric power tools—Safety requirements—Part6:Assembly power tools for threaded fasteners28.1.2009EN792-6:200028.12.2009CEN EN792-7:2001+A1:2008Hand-held non-electric power tools—Safety requirements—Part7:Grinders28.1.2009EN792-7:200128.12.2009CEN EN792-8:2001+A1:2008Hand-held non-electric power tools—Safety requirements—Part8:Sanders and polishers28.1.2009EN792-8:200128.12.2009CEN EN792-9:2001+A1:2008Hand-held non-electric power tools—Safety requirements—Part9:Diegrinders28.1.2009EN792-9:200128.12.2009CEN EN792-10:2000+A1:2008Hand-held non-electric power tools—Safety requirements—Part10:Compression power tools28.1.2009EN792-10:200028.12.2009CEN EN792-11:2000+A1:2008Hand-held non-electric power tools—Safety requirements—Part11:Nibblers and shears28.1.2009EN792-11:200028.12.2009CEN EN792-12:2000+A1:2008Hand-held non-electric power tools—Safety requirements—Part12:Small circular,small oscillating and reciprocating saws28.1.2009EN792-12:200028.12.2009CEN EN792-13:2000+A1:2008Hand-held non-electric power tools—Safety requirements—Part13:Fastener driving tools28.1.2009EN792-13:200028.12.2009CEN EN809:1998Pumps and pump units for liquids—Common safety requirements15.10.1998—EN809:1998/AC:2001CEN EN815:1996+A2:2008Safety of unshielded tunnel boring machines and rodless shaft boringmachines for rock—Safety requirements28.1.2009EN815:199628.12.2009CEN EN818-1:1996+A1:2008Short link chain for lifting purposes—Safety—Part1:General condi-tions of acceptance22.8.2008EN818-1:199628.12.2009CEN EN818-2:1996+A1:2008Short link chain for lifting purposes—Safety—Part2:Medium toler-ance chain for chain slings—Grade822.8.2008EN818-2:199628.12.2009ESO(1)Reference and title of the harmonised standard(and reference document)First publicationOJReference of supersededstandardof presumptionof conformity ofsupersededstandard(Note1)CEN EN818-3:1999+A1:2008Short link chain for lifting purposes—Safety—Part3:Medium toler-ance chain for chain slings—Grade422.8.2008EN818-3:199928.12.2009CEN EN818-4:1996+A1:2008Short link chain for lifting purposes—Safety—Part4:Chain slings—Grade822.8.2008EN818-4:199628.12.2009CEN EN818-5:1999+A1:2008Short link chain for lifting purposes—Safety—Part5:Chain slings—Grade422.8.2008EN818-5:199928.12.2009CEN EN818-6:2000+A1:2008Short link chain for lifting purposes—Safety—Part6:Chain slings—Specification for information for use and maintenance to be provided bythe manufacturer22.8.2008EN818-6:200028.12.2009CEN EN818-7:2002+A1:2008Short link chain for lifting purposes—Safety—Part7:Fine tolerancehoist chain,Grade T(Types T,DAT and DT)22.8.2008EN818-7:200228.12.2009CEN EN836:1997Garden equipment—Powered lawnmowers—Safety4.6.1997—EN836:1997/A1:199713.3.1998Note3Date expired(30.4.1998)EN836:1997/A2:200127.11.2001Note3Date expired(27.11.2001)EN836:1997/A3:200431.12.2005Note3Date expired(31.12.2005)EN836:1997/AC:2006CEN EN842:1996+A1:2008Safety of machinery—Visual danger signals—General requirements,design and testing28.1.2009EN842:199628.12.2009CEN EN848-1:2007Safety of woodworking machines—One side moulding machines withrotating tool—Part1:Single spindle vertical moulding machines 6.11.2007EN848-1:1998Date expired(31.8.2008)CEN EN848-2:2007Safety of woodworking machines—One side moulding machines withrotating tool—Part2:Single spindle hand fed/integrated fed routingmachines 6.11.2007EN848-2:1998Date expired(31.8.2008)CEN EN848-3:1999Safety of woodworking machines—One side moulding machines withrotating tool—Part3:Numerical control(NC)boring machines androuting machines15.4.2000—Warning:With regard to the characteristics of and the choice of materials for curtain guards,especially strip curtains,this publication does not concern clauses5.2.7.1.2(b),paragraphs1to6,of this standard,the application of which does not confer a presumption of conformity to the essential health and safety requirements1.3.2,1.3.3and1.4.1of Annex I to Directive98/37/EC in conjunction with essential health and safety requirement1.1.2(a)of that Annex.ESO(1)Reference and title of the harmonised standard(and reference document)First publicationOJReference of supersededstandardof presumptionof conformity ofsupersededstandard(Note1)CEN EN859:2007Safety of woodworking machines—Hand fed surface planing machines 24.6.2008EN859:1997Date expired(31.12.2008)CEN EN860:2007Safety of woodworking machines—One side thickness planingmachines6.11.2007EN860:199730.6.2010CEN EN861:2007Safety of woodworking machines—Surface planing and thicknessingmachines6.11.2007EN861:199730.6.2010CEN EN869:2006Safety of machinery—Safety requirements for pressure metal diecastingunits 8.5.2007EN869:1997Date expired(8.5.2007)CEN EN894-1:1997+A1:2008Safety of machinery—Ergonomics requirements for the design ofdisplays and control actuators—Part1:General principles for humaninteractions with displays and control actuators This is the firstpublicationEN894-1:199728.12.2009CEN EN894-2:1997+A1:2008Safety of machinery—Ergonomics requirements for the design ofdisplays and control actuators—Part2:Displays This is the firstpublicationEN894-2:199728.12.2009CEN EN894-3:2000+A1:2008Safety of machinery—Ergonomics requirements for the design ofdisplays and control actuators—Part3:Control actuators This is the firstpublicationEN894-3:200028.12.2009CEN EN907:1997Agricultural and forestry machinery—Sprayers and liquid fertilizerdistributors—Safety23.10.1997—CEN EN908:1999Agricultural and forestry machinery—Reel machines for irrigation—Safety11.6.1999—CEN EN909:1998Agricultural and forestry machinery—Centre pivot and moving lateraltypes irrigation machines—Safety11.6.1999—CEN EN930:1997Footwear,leather and imitation leather goods manufacturing machines—Roughing,scouring,polishing and trimming machines—Safety require-ments13.3.1998—EN930:1997/A1:200431.12.2005Note3Date expired(31.12.2005)CEN EN931:1997Footwear manufacturing machines—Lasting machines—Safety require-ments13.3.1998—EN931:1997/A1:200431.12.2005Note3Date expired(31.12.2005)ESO(1)Reference and title of the harmonised standard(and reference document)First publicationOJReference of supersededstandardof presumptionof conformity ofsupersededstandard(Note1)CEN EN940:1997Safety of woodworking machines—Combined woodworking machines23.10.1997—EN940:1997/AC:1997CEN EN953:1997Safety of machinery—Guards—General requirements for the designand construction of fixed and movable guards13.3.1998—CEN EN972:1998Tannery machines—Reciprocating roller machines—Safety require-ments15.10.1998—CEN EN981:1996+A1:2008Safety of machinery—System of auditory and visual danger and infor-mation signals28.1.2009EN981:199628.12.2009CEN EN982:1996+A1:2008Safety of machinery—Safety requirements for fluid power systems andtheir components—Hydraulics28.1.2009EN982:199628.12.2009CEN EN983:1996+A1:2008Safety of machinery—Safety requirements for fluid power systems andtheir components—Pneumatics28.1.2009EN983:199628.12.2009CEN EN996:1995Piling equipment—Safety requirements15.10.1996—EN996:1995/A1:199911.6.1999Note3Date expired(31.7.1999)EN996:1995/A2:200320.4.2004Note3Date expired(20.4.2004)EN996:1995/A1:1999/AC:1999CEN EN999:1998+A1:2008Safety of machinery—The positioning of protective equipment inrespect of approach speeds of parts of the human body28.1.2009EN999:199828.12.2009CEN EN1005-1:2001+A1:2008Safety of machinery—Human physical performance—Part1:Termsand definitions This is the firstpublicationEN1005-1:200128.12.2009CEN EN1005-2:2003+A1:2008Safety of machinery—Human physical performance—Part2:Manualhandling of machinery and component parts of machinery This is the firstpublicationEN1005-2:200328.12.2009CEN EN1005-3:2002+A1:2008Safety of machinery—Human physical performance—Part3:Recom-mended force limits for machinery operation This is the firstpublicationEN1005-3:200228.12.2009CEN EN1005-4:2005+A1:2008Safety of machinery—Human physical performance—Part4:Evalua-tion of working postures and movements in relation to machinery This is the firstpublicationEN1005-4:200528.12.2009ESO(1)Reference and title of the harmonised standard(and reference document)First publicationOJReference of supersededstandardof presumptionof conformity ofsupersededstandard(Note1)CEN EN1010-1:2004Safety of machinery—Safety requirements for the design and construc-tion of printing and paper converting machines—Part1:Commonrequirements31.12.2005—CEN EN1010-2:2006Safety of machinery—Safety requirements for the design and construc-tion of printing and paper converting machines—Part2:Printing andvarnishing machines including pre-press machinery2.8.2006—CEN EN1010-3:2002Safety of machinery—Safety requirements for the design and construc-tion of printing and paper converting machines—Part3:Cuttingmachines14.8.2003—CEN EN1010-4:2004Safety of machinery—Safety requirements for the design and construc-tion of printing and paper converting machines—Part4:Bookbinding,paper converting and finishing machines31.12.2005—CEN EN1010-5:2005Safety of machinery—Safety requirements for the design and construc-tion of printing and paper converting machines—Part5:Machines forthe production of corrugated board and machines for the conversion offlat and corrugated board31.12.2005—CEN EN1012-1:1996Compressors and vacuum pumps—Safety requirements—Part1:Compressors15.10.1996—CEN EN1012-2:1996Compressors and vacuum pumps—Safety requirements—Part2:Vacuum pumps15.10.1996—CEN EN1028-1:2002+A1:2008Fire-fighting pumps—Fire-fighting centrifugal pumps with primer—Part1:Classification—General and safety requirements28.1.2009EN1028-1:200228.12.2009CEN EN1028-2:2002+A1:2008Fire-fighting pumps—Fire-fighting centrifugal pumps with primer—Part2:Verification of general and safety requirements22.8.2008EN1028-2:200228.12.2009CEN EN1032:2003+A1:2008Mechanical vibration—Testing of mobile machinery in order to deter-mine the vibration emission value This is the firstpublicationEN1032:200328.12.2009CEN EN1034-1:2000Safety of machinery—Safety requirements for the design and construc-tion of paper making and finishing machines—Part1:Commonrequirements31.12.2005—CEN EN1034-2:2005Safety of machinery—Safety requirements for the design and construc-tion of paper making and finishing machines—Part2:Barking drums2.8.2006—ESO(1)Reference and title of the harmonised standard(and reference document)First publicationOJReference of supersededstandardof presumptionof conformity ofsupersededstandard(Note1)CEN EN1034-3:1999Safety of machinery—Safety requirements for the design and construc-tion of paper making and finishing machines—Part3:Winders and slit-ters,plying machines20.5.2000—CEN EN1034-4:2005Safety of machinery—Safety requirements for the design and construc-tion of paper making and finishing machines—Part4:Pulpers and theirloading facilities2.8.2006—CEN EN1034-5:2005Safety of machinery—Safety requirements for the design and construc-tion of paper making and finishing machines—Part5:Sheeters2.8.2006—CEN EN1034-6:2005Safety of machinery—Safety requirements for the design and construc-tion of paper making and finishing machines—Part6:Calander2.8.2006—CEN EN1034-7:2005Safety of machinery—Safety requirements for the design and construc-tion of paper making and finishing machines—Part7:Chests31.12.2005—CEN EN1034-13:2005Safety of machinery—Safety requirements for the design and construc-tion of paper making and finishing machines—Part13:Machines forde-wiring bales and units2.8.2006—CEN EN1034-14:2005Safety of machinery—Safety requirements for the design and construc-tion of paper making and finishing machines—Part14:Reel splitter2.8.2006—CEN EN1034-22:2005Safety of machinery—Safety requirements for the design and construc-tion of paper making and finishing machines—Part22:Wood Grinders31.12.2005—CEN EN1035:1998Tannery machines—Moving platen machinery—Safety requirements31.12.2005—CEN EN1037:1995+A1:2008Safety of machinery—Prevention of unexpected start-up22.8.2008EN1037:199528.12.2009CEN EN1088:1995+A2:2008Safety of machinery—Interlocking devices associated with guards—Principles for design and selection28.1.2009EN1088:199528.12.2009CEN EN1093-1:2008Safety of machinery—Evaluation of the emission of airborne hazardoussubstances—Part1:Selection of test methods This is the firstpublicationEN1093-1:199828.12.2009ESO(1)Reference and title of the harmonised standard(and reference document)First publicationOJReference of supersededstandardof presumptionof conformity ofsupersededstandard(Note1)CEN EN1093-2:2006+A1:2008Safety of machinery—Evaluation of the emission of airborne hazardoussubstances—Part2:Tracer gas method for the measurement of theemission rate of a given pollutant22.8.2008EN1093-2:200628.12.2009CEN EN1093-3:2006+A1:2008Safety of machinery—Evaluation of the emission of airborne hazardoussubstances—Part3:Test bench method for the measurement of theemission rate of a given pollutant22.8.2008EN1093-3:200628.12.2009CEN EN1093-4:1996+A1:2008Safety of machinery—Evaluation of the emission of airborne hazardoussubstances—Part4:Capture efficiency of an exhaust system—Tracermethod22.8.2008EN1093-4:199628.12.2009CEN EN1093-6:1998+A1:2008Safety of machinery—Evaluation of the emission of airborne hazardoussubstances—Part6:Separation efficiency by mass,unducted outlet28.1.2009EN1093-6:199828.12.2009CEN EN1093-7:1998+A1:2008Safety of machinery—Evaluation of the emission of airborne hazardoussubstances—Part7:Separation efficiency by mass,ducted outlet28.1.2009EN1093-7:199828.12.2009CEN EN1093-8:1998+A1:2008Safety of machinery—Evaluation of the emission of airborne hazardoussubstances—Part8:Pollutant concentration parameter,test benchmethod28.1.2009EN1093-8:199828.12.2009CEN EN1093-9:1998+A1:2008Safety of machinery—Evaluation of the emission of airborne hazardoussubstances—Part9:Pollutant concentration parameter,room method28.1.2009EN1093-9:199828.12.2009CEN EN1093-11:2001+A1:2008Safety of machinery—Evaluation of the emission of airborne hazardoussubstances—Part11:Decontamination index28.1.2009EN1093-11:200128.12.2009CEN EN1114-1:1996Rubber and plastics machines—Extruders and extrusion lines—Part1:Safety requirements for extruders8.5.1997—CEN EN1114-2:1998+A1:2008Plastics and rubber machines—Extruders and extrusion lines—Part2:Safety requirements for die face pelletisers28.1.2009EN1114-2:199828.12.2009CEN EN1114-3:2001Rubber and plastics machines—Extruders and extrusion lines—Part3:Safety requirements for haul-offs27.11.2001—CEN EN1127-1:2007Explosive atmospheres—Explosion prevention and protection—Part1:Basic concepts and methodology24.6.2008EN1127-1:199728.12.2009CEN EN1127-2:2002+A1:2008Explosive atmospheres—Explosion prevention and protection—Part2:Basic concepts and methodology for mining22.8.2008EN1127-2:200228.12.2009。
manual pro(PERMA自动注油机)
perma PRO perma PRO Operating InstructionsPRO 250 / 500This operating manual is valid for the lubricator perma PRO with PRO LC-units 250 cc and 500 cc.©2003 perma-tec GmbH & Co. KGWithout the specific approval of perma-tec GmbH & Co. KG no part of this documentation can be copied or made available to third parties.We have taken great care when compiling all the details contained in this documentation. However, we cannot rule out discrepancies and we reserve the right to make technical changes to the product without giving advance notice.We do not assume any judicial responsibility or liability for damages which may ensue as a result.We will include any necessary changes in the next edition.Compiled and printed: 18 / 11 / 2005 ©K o n z e p t i o n & G e s t a l t u n g A r b e i t s s i c h e r h e i t u n d D o k u m e n t a t i o n A R A , 4 8 1 6 7 M ün s t e r , w w w . a r a -m u e n s t e r . d eLubrication System perma PROQuick Reference Guide for the Lubrication Systemperma PROOn this page you will find some important information for quick and easy operation and setting of the perma PRO. Before the first installation of the perma PRO, and whenever you need detailed instructions, you should read the complete Operating Manual which contains information that must be observed. Make sure to follow the instructions given in the chapter “Safety Notes”.♦ Insert a new battery set into the battery compartment (follow directions of the arrows).♦ On the assembly plate, insert the contact pin in the correct slot for the PRO LC-unit that youintend to use (250 or 500).♦ Place the PRO LC-unit inside the cover and remove the plug of the PRO LC-unit. ♦ Push the PRO LC-unit into the cover until lubricant comes out of the opening. ♦ If necessary, mount the drive unit onto the mounting device and attach it with thethree pre-drilled holes. ♦ Place the PRO LC-unit with its cover on the drive-unit. Make sure that the catch locks and thatthe teeth of PRO LC-unit and drive unit interlock.♦ Turn the cover clockwise until the bayonet catch locks.♦ Hold down the ON/OFF/SELECT button until the …Remaining Volume“ appears in thedisplay and the green LED starts blinking.♦ Refer to the manufacturer’s guidelines about the lubrication point that you want to lubricate,in order to determine the required lubricant amount in cc per one hundred operating hours. ♦ Refer to chart 3 (chapter 6.7) and find your required lubrication amount. Based on that, thechart will show you the required PRO LC-unit size, the setting of the discharge period, and the setting mode.♦ You may also refer to our perma Select program which can be downloaded from our webpage free of charge. It helps you in selecting the correct settings.♦ Keep the MODE/SAVE button pressed until you have reached the Configuration Menu. ♦ Push the MODE/SAVE button as many times as it takes to reach the desired setting(Days, Weeks or Months).♦ When the display shows the correct setting mode, push the ON/OFF/SELECT buttonas many times as it takes to reach the desired discharge period.♦ Keep the MODE/SAVE button pressed until the display shows the …remaining volume“.♦ Keep the ON/OFF/SELECT button pressed until the display shows ("–– ") .Protection coverWith bayonet catch for quick opening/closing.PRO LC – Unit(Lubrication Canister) Cartridge, piston, spindle filled with lubricant.Red LEDindication.TypeProduct type and size of PRO LC-unit.ContentDescription of the contained lubricant and the filling date.DisplayInforms about operating conditions, malfunctions, settings, and thelubricant volume left in the PRO LC-unit..Push Button: ON/OFF/SELECTUsed to turn the unit on and off, and also to gradually increase the discharge period.(Jumper) To set the size Battery – Set Assembly of the perma PRO // Exchange of PRO LC-unit (refer to chapters 4 and 7)Starting the perma PRO (refer to chapter 6.5)Determine Discharge Period (refer to chapter 6.7)Setting the Discharge Period (refer to chapter 6.8)Save Settings (refer to chapter 6.8)Stopping the perma PRO (refer to chapter. 6.6)Table of ContentsThe lubrication system perma PRO 1Quick reference guide 2Content31. Various41.1 Deliveries 1.2 Storage 1.3 Markings 1.4 Intended Usage 1.5 Legal Requirements2. Safety Instructions62.1 Persons responsible for safety 2.2 General Safety Instructions 2.3 Safety Information for perma PRO3. Technical Data73.1 Design of the perma PRO Lubricator4.Mounting and Assembly of the Lubrication System 94.1 Mounting the Drive Unit onto a Fixing Device for Wall-Mounting 4.2 Assembly of the Lubricator5.Display and Control Elements of the Lubrication System 125.1 Display Elements 5.2 Function Indication on the Display 5.3 Function Indication via the LEDs 5.4 Control Buttons6. Operation and Control 136.1 Preparations 6.2 Prior to Operation 6.3 Setting into Operation 6.4 During Operation 6.5 Switching the Lubrication System On 6.6 Switching the Lubrication System Off 6.7 Determining the Discharge Period 6.8 Setting the Discharge Period 6.9 Calculation of the Remaining Discharge Period7.Replacement of the PRO LC-Unit 197.1 Setting the Volume of the PRO LC-Unit 7.2 How to Replace the PRO LC-Unit8. Trouble Shooting 218.1 Error Messages on the Display 8.2 Trouble Shooting Guide9.Accessories and Spare Parts2210. Disposal2411. Service24perma-tecGmbH & Co. KGInternet: e-mail: info@1. VariousAbout this Operating Manual♦ This operating manual is intended for the safe operation of the perma PRO automatic lubricator.It contains safety instructions which must be adhered to.♦ Everyone who works on or with the lubricator must have access to this operating manual during theirshift. They must also pay attention to all relevant instructions and notices.♦ The operating manual must always be kept complete and in easy to read condition.Terms Used♦ Lubricator perma PROIn the following text, the “lubricator“ will either be called “lubricator“ or by its name “perma PRO“.♦ Lubrication CanisterIn the following text, the “Lubrication Canister“ will be called PRO LC-unit. The user can order the PRO LC-unit with different lubricants and in size 250 cc and 500 cc.Usage of Safety InstructionsAll safety instructions in this operating manual are standardized.Danger SignsThis sign warns you of any danger to people’s health or to subjects.This sign alerts you to application tips which will help you in doing certain tasks quicker and safer.1.1 Delivery / Content♦ perma PRO will be delivered according to customer specifications in regards to type of grease and sizeof PRO LC-unit.The user must only assemble it and adjust the desired settings.♦Mounting device and screws included.♦ Operating instructions and EC Conformity Declaration included.Upon delivery, make sure to check if the delivered goods correspond to your order. perma-tec GmbH & Co. KG will not accept liability for subsequent claims of any shortcomings. ♦ Please immediately forward any claims:of noticeable transport damage: directly to the forwarder.of noticeable faults, shortcomings or defects: directly to your perma distributor.1.2 StorageWhen the lubricators are not immediately installed, you must ensure appropriate storage conditions in dry, dust free places with a temperature of +20°C ±5° C (+68°F ±9°F).Please make sure that the cover disc (2) with plug (3) on PRO / PRO C drive units (1) is never removed for a longer period since this will cause the internal support battery to empty prematurely.Remove the cover disc only right before you intend to use the lubricator.Extended storage periods without cover disc/plug or without an PRO LC unit should be avoided.12.Conformity Declaration for perma PROEC – Conformity DeclarationAccording to the Machinery Directive 98/37/EC and according to EMV (Electromagnetic Compatibility) – Directive 89/336/EWG.The manufacturerperma-tec GmbH & Co. KG Hammelburger Straße 21D – 97717 Euerdorfhereby declares that the product as described in the given statement conforms to the regulationsappertaining to the directives referred to above, including any amendments thereto which are in force at the time of the declaration.Product description: Automatic lubricator Product name: Lubricator perma PROType: perma PRO 250 and perma PRO 500The following harmonised standards were applied:EN 292 – 1: 1991 Safety of machinery – basic concepts, general terms of reference as regards design and construction– Section 1: Basic Terminology, MethodologyEN 292 – 2:1991Safety of machinery – basic concepts, general terms of reference as regards design and construction– Section 2: Technical terms of reference and specificationsEN 60204 – 1:1998 Machinery’s electrical equipmentEuerdorf, 09 December 2002perma-tec GmbH & Co. KGPeter Mayr, Managing Director Dr. Michael Weigand, Technical ManagementThis declaration certifies conformity to the directives referred to but it is not a warranty of qualities. The safety instructions of the operating manual are to be observed.(3(2)10. DisposalHelp us in protecting the environment and saving resources by recycling valuable raw material. Please follow your local waste disposal regulations.11.Service♦ Please contact your local supplier for availability and cost of the following:Returning of the empty lubricator for environmentally safe recycling or disposal.or:exchange of battery set. exchange of PRO LC-unit.setting the desired discharge period.1.3 Markings♦ The lubricator perma PRO is clearly marked with a label on the drive system and a label on the PROLC-unit.♦ CE mark on the drive unit and the PRO LC-unit.♦ Manufacturer:perma-tec GmbH & Co. KG Hammelburger Straße 21 D – 97717 EuerdorfInternet: e–mail: info@1.4 Intended UsageThe lubricator perma PRO♦ Immediately supplies all lubrication points with lubricant, at a pressure build-up of max. 25 bar (360psi.), permanently, precisely and independent of temperature.♦ Can be used for all lubrication points of sliding- and roller bearings, drive- and transport chains,sliding guideways, open gears and seals.♦ Should only be connected to/used with original lubrication tubes from perma-tec GmbH & Co. KG. ♦ Is intended for use on machinery and equipment.♦ Is only to be used for the ordered purpose and purposes confirmed by perma-tec. ♦ Is only to be used for operating conditions recommended in this operating manual. ♦ Is only to be used with settings and variations recommended in this operating manual.Any other usage, setting, addition, and variation is considered to be inappropriate!1.5 Legal RequirementsLiability♦ The information, data and tips stated in this operating manual were up-to-data as of the printing date.No claims for already delivered lubricators perma PRO can be made based on the information, pictures and descriptions♦ perma-tec GmbH & Co. KG can not be held liable for damages and malfunctions caused by:inappropriate usage;unauthorized alterations to the drive system or the PRO LC-unit; inappropriate operations on or with the lubricator; incorrect operation and settings of the lubricator; incorrect settings of time and size of the lubricator; ignoring the operating manual.Warranty♦ Warranty terms and conditions: see terms and conditions of sale and delivery appertaining to perma-tec GmbH & Co. KG.♦ Lodge any warranty claims with your local supplier immediately after the defect or error has beenidentified.♦ The warranty expires in all instances where no liability claims can be enforced.2.Safety Instructions2.1Persons responsible for safety♦ The operator or his safety officer must warrant,that all the relevant regulations, instructions and laws are adhered to; that only qualified personnel will work with and on the lubricator;that unauthorized personnel are not allowed to work with and on the lubricator;that the safety regulations are adhered to when mounting the lubricator or during maintenance.2.2 General Safety Instructions♦ We are not laying claim to completeness in regards to these safety instructions. Please contact perma-tec Customer Service if you have any questions or problems.♦ At the time of delivery the lubricator is in line with state-of-the-art technology and in principle isconsidered to be safe to operate.♦ Dangers emanate from the lubricator for persons, the lubricator itself and for other material assets of theoperator if:unqualified personnel operates the lubricator;the lubricator is used inappropriately and for operations that it was not intended to be used for; the lubricator setting / variation is incorrect;the lubricator is opened by force while in operation;the lubricator is not mounted with the perma mounting device;the tube connection to the lubrication point was not carried out and attached correctly; ♦ Operate the lubricator only when it is in perfect condition.♦ Retrofitting, changing, or reconstructing the lubricator is prohibited. perma-tec must be consulted first. ♦ Only original tube connections and connectors from perma-tec can be used on or with the lubricationsystem since these will withhold high pressures of up to 25 bar (360psi).♦ Ambient media, especially chemically aggressive substances, can attack seals and plastic.2.3 Safety information for perma PRO Safety during Installation and Maintenance♦ Ensure that all workstations and traffic routes are clean and safe!♦ Ensure that the relevant regulations and guidelines are adhered to when the installation or maintenancework is carried out in places where danger of falling exists.♦ Ensure that the relevant safety and operating instructions are observed when the lubricators are installedor serviced on machines or in factories (i.e. to Stop the machine).Safety When Handling the PRO LC-Unit♦ Avoid contact of lubricant with eyes, skin, and clothing! ♦ Avoid swallowing of lubricant!♦ Prevent lubricant from getting into soil or sewer system! ♦ Observe safety data sheets of lubricants!♦ Lubricant on traffic ways will increase the danger of slipping! Therefore, immediately clean lubricant fromfloors with special cleaner.♦ Only use original PRO LC-units from perma-tec!Safety when Handling Batteries!♦ Avoid contact of battery substances with eyes, skin and clothing! ♦ Avoid swallowing any leaking battery substances! ♦ Observe safety data sheets for batteries!♦Do not expose batteries to extreme heat and do not throw into open fire!♦ Do not recharge batteries!♦ Ensure that regulations for waste disposal of batteries are observed! ♦ Only use original battery sets from perma-tec!Table 5 bSpare partsPart No. Illustrationperma PRO mounting device27.008.007400 g grease cartridge for pre-lubrication with grease press filled with SF 04400 g grease cartridge for pre-lubrication with grease press filled with other lubricants on requeston requestStraight connecting piece G 1/8 for lubricant tubes27.008.010Angle G 1/8 for connecting a lubricant tube27.008.011Special lubricant tube with different lengths27.008.009Reducer G 3/8 – G 1/4on requestCD ROM with SELECT software (calculation of the lubricant amount), lubrication and maintenance schedule and operating instructions as PDF fileon request9.Accessories and Spare PartsDue to the high pressure of up to 25 bar, you should only use genuine spare parts and accessories from perma-tec in order to ensure a reliable operation of the lubrication system. This especially applies to lubricant tubes.Spare parts and accessories must meet the technical requirements!This is always guaranteed with genuine spare parts and accessories from perma-tec.3. Technical DataTable 1Application area for out of specification range standard grease No warranty!The dashed standard grease- and dotted low temperature-lines show the maximum values allowed.If your application is out of the specification range shown in this diagram, please contact your local distributor. perma-tec cannot be held liable for these applications. Example:1. The application temperature is +5°C / +41°F. What is the maximum tube length allowed for standard grease?Correct Answer: 3m max. tube length for standard grease, 5m max. tube length for low temp. grease (arrow 1 meets the dashed line of the standard grease range at 3m)2. You want to use a 4m tube. Up to which temperature can the system be used?Correct Answer: +10°C/50°F with standard grease -5°C/23°F with low temp. grease (arrow 3 meets the -20°C-10°C 0°C 10°C 20°C 30°C 40°C50°C60°C 0°F20°F 40°F 60°F 80°F100°F 120°F140°FPRO 250 PRO 500 Volume of the PRO LC-unit 250 cc 500 cc Length (L) 210 mm 260 mm Diameter (D) 92 mm 92 mm Weight, empty1.30 kg 1.37 kg Weight, filled with SF04 1.53 kg 1.82 kg Discharge period1 day to 24 months1 day to 12 monthsDischarged volume per lubrication impulse 0.5 ccApplication temperature -20° C to +60 °C / -4°F to +140°FMaximum pressure build-up25 bar / 360 psiMaximum tube length (inner-Ø 5mm) 5 mLubricantsGreases up to rated consistency NLGI 2C ombination of these Maximum-Values can only be realized by temperatures of ≥20°C/ 68°F. At lower temperatures, the application is limited accordingto the diagram below.Power supply (0° C to +60 °C / +32°F to +140 °F)Battery set PRO B (3 V alkaline manganese, not rechargeable)Power supply, low temperature (-20°C to +60°C / -4°F to +140°F) Battery set PRO B PLUS (3 V lithium, not rechargeable)Connection thread G 3/8 outside – G1/8 insideProtection class IP 54D LFigure 1T e m p e r a t u r e i n °Ctube length in meterT e m p e r a t u r e i n °FSpare partsArt. No. IllustrationPRO LC-unit (250 cc) filled with special lubricant SF 04PRO LC-unit (250 cc) filled with other lubricants2220004608on requestPRO LC-unit (500 cc) filled with special lubricant SF 04PRO LC-unit (500 cc) filled with other lubricants2230004609on requestProtection cover 250 cc made of transparent plasticProtection cover 250 cc made of aluminium for applications with ester-containing lubricants22991010002299102001Protection cover 500 cc made of transparent plasticProtection cover 500 cc made of aluminium for applications with ester-containing lubricants 22991020002299102002Battery set B(0° C to +60° C / 32°F to 140°F)2299001606Battery set B PLUS(-20° C to +60° C / -4°F to +140°F)22990026073.1 Design of the perma PRO LubricatorLubricators are available as 250 cc and 500 cc versions and they can be supplied with the lubricant requested by the customer. They consist of (refer to figure 2): 8. TroubleShooting8.1 Error Messages on the DisplayPossible errors of the lubrication system are detected by the electronic control system andare indicated on the display. If an error is displayed, the system is switched off until the cause of the error has been eliminated and the error message has been acknowledged.Error messages are acknowledged and reset by pushing the ON/OFF/SELECT button.8.2 Trouble shooting guideIf there are malfunctions during the operation of the lubrication system, please check for possible causes using the following table (refer to table 4). If you have to deal with a malfunction that is not listed in the table below, please contact your local supplier for technical support.Every time that an error message is displayed, the red LED is also blinking.Table4Indicationof thedisplayError Possible cause Remedial measuresE I Lubricator has been switchedoffExcess motor current of thelubricator motor due to ablocked outletBattery set is emptyClear the blockage andacknowledge the fault bypushing and holding down theON/OFF/SELECT button.Insert a new battery set anduse a full PRO LC-unit.E4 Lubricator has been switchedoffDrive mechanism is defective. Exchange the drive unit.LC System does not detectthe PRO LC-unitSignal of the jumper is notfoundNo PRO LC-unit installedJumper has not been insertedcorrectly or is missingInstall an PRO LC-unit.Insert the jumper in thecorrect slot for the PRO LC-unit size that you intend touse.L o No power supplied to thesystem from the batteryNo battery inserted or batteryset emptyInsert a new battery set anduse a full PRO LC-unit.7.2 How to Replace the PRO LC-Unita) Turn the protection cover on the drive unit counter-clockwise and remove it.b) Remove the empty PRO LC-unit. The display indicates “LC“ and the red LED is blinking.c) Remove the used battery set from the drive unit. The display indicates “L O“.d) Insert the new battery set into the drive unit. Follow the directions of the arrows. The displayindicates “LC“ again.e) Remove the plug of the PRO LC-unit.f) Push the PRO LC-unit into the protection cover until lubricant comes out of the opening.(refer to figure 6, chapter 4).g) Place the new PRO LC-unit on the drive unit, turn it until the catch locks and the teeth of the PRO LC-unit and the drive unit interlock. The control system automatically recognizes the new PRO LC-unit.The display indicates "–– " if the perma PRO was switched off prior to the replacement of thePRO LC-unit. Or it indicates "99 % Vol.“ if the perma PRO was switched on before the replacement.You should only use completely full perma-tec PRO LC-units, in order to guarantee a trouble-freeoperation.h) The lubrication system continues to operate with the previous setting of the discharge period.i) If necessary, change the discharge period of the lubricator (refer to chapter 6.8).The discharging process automatically starts using the previous settings of the discharge period if the lubricator was switched on prior to the replacement of the PRO LC-unit.If the lubricator was previously switched off, the discharging process must be started by pushing the ON/OFF/SELECT button. (refer to figure 13, chapter 6.5) 4. Mounting and Assembly of the Lubrication System4.1 Mounting the Drive Unit onto a Fixing Device for Wall-Mounting♦Attach the supplied mounting device to the drive unit using the two enclosed hex head bolts (M6 x 16) and the two washers.♦Screw the mounting device with the drive unit onto a support of your system.For the position of the bores of the three fixing screws (141.5 x 45) refer to figure 3 below. You haveto use at least three hexagon screws M6 x 25.♦Before you connect the outlet of the drive unit to the lubricant tube, you have to make sure that the lubrication points and the complete lubricant tube is pre-lubricated with the same lubricant that iscontained in the PRO LC-unit. For that, perma-tec offers a 400 g lubrication cartridge for manually-operated grease presses with the requested lubricant.♦Connect the lubricant tube (connection G 3/8 outside or G 1/8 inside) to the outlet of the drive unit and install the tube correctly between the outlet and the lubrication point. The lubricant tube must notbe longer than five meters.M ake sure that you assemble the connections and lubricant tubes correctly and tightly to avoid possible leakage.Figure32 hex head boltsM6 x 16, maximumtorque 3 Nm (suppliedfor attaching theperma PRO to themounting device)Hexagon screwsM6 x 25(for wall mounting)2 hexagon screwsM6 x 25(for wall mounting)4.2 Assembly of the Lubricatora)♦ Insert the battery set into the drive unit (according to the direction of the arrow on the label). ♦ Check the position of the jumper, which has to correspond to the size of the PRO LC-unit(refer to figure 4 and chapter 7.1).Figure 4b)♦ Place the PRO LC-unit inside the protection cover and remove the plug of the PRO LC-unit(refer to figure 5).7. Replacement of the PRO LC-UnitThe Following Must Always Be Taken into AccountIf the replacement of an empty PRO LC-unit becomes necessary, it will be indicated by a simultaneous blinking of the red and the green LED. Additionally, the display indicates that the PRO LC-unit is empty (refer to figure 21).Figure 21If you replace the PRO LC-unit, you also have to change the battery set. Otherwise, the correct operation of the lubricator cannot be guaranteed!If you replace the PRO LC-unit by an PRO LC-unit of a different size, a corresponding protection cover (refer to table 5a, chapter 9) must be used.After the installation of the new PRO LC-unit, the control system continues to operate using the previously valid setting of the discharge period.7.1Setting the Volume of the PRO LC-UnitYou have to set the size of the PRO LC-unit by inserting the contact pin (jumper) into the base plate ofFigure 22Since the drive unit and the control board must be protected against moisture, an exchange may only be carried out in dry conditions!Attention!If an PRO LC-unit has been removed from the lubricator and another PRO LC-unit has been installed, the control system always assumes that this PRO LC-unit is new and full. Therefore you should never use an PRO LC-unit if it is not completely full!Setting 250 ccSetting 500 ccCatchInterlocking teethJumperContact pin (jumper)Plugged-in jumper for size 250 ccJumperBattery setProtection cover PRO LC-unit PlugLow-Temperature Cut-Off of the Lubrication SystemThe temperature range from 0° C to -19° C ( 32°F to –2.2°F) is indicated by a blinking ice crystal symbol (refer to figure 20).In this temperature range the lubrication system perma PRO continues to operate without interruption. Please note, that in this temperature range an additional discharge is not possible!Figure 20 Display with a blinking ice crystal (in this example with 89 % Vol.)In order to protect the system from damage, the low-temperature cut-off of the lubrication system isautomatically carried out by the control system and the built-in temperature sensor.If the temperature reaches or falls below -20°C (-4°F), the lubricator is switched off by the low-temperaturecut-off and the ice crystal symbol is permanently indicated on the display. The remaining volume is stilldisplayed in % Vol.From this time onwards, the lubricant is no longer discharged. You have to take this fact intoaccount if your system continues to operate in order to prevent damages!As soon as the temperature rises and reaches -19° C (-2.2°F) or higher, the control systemswitches the lubrication system on again.The display shows the remaining volume and the blinking ice crystal symbol.All discharges (except additional discharges), accumulated during the shut-off, will be caught upwhen the system continues operation (at a max. of two additional discharges with every regulardischarge).6.9 Calculation of the Remaining Discharge PeriodPlease note, that in case of one or several additional discharges, the remaining discharge period of thelubrication system must be recalculated. This also applies in case of a cut-off of the lubrication systemdue to a long machine standstill (e.g. weekends or annual holidays) or in case of a low-temperaturecut-off carried out by the system if temperatures reach -20° C (-4°F).You should also note the result of your calculation of the remaining discharge period in your lubricationand maintenance schedule.Formula: R DP =100RV*SDPSDP: Set Discharge Period of the lubricator (days, weeks, months)RV: Remaining Volume (displayed in % Vol.)R DP: Remaining discharge period (days, weeks, months depending on SDP)Example of a Calculation of the Remaining Discharge PeriodThe perma PRO with a 250 cc PRO LC-unit was originally set to a discharge period (SDP) of eight months,since the lubrication point needs 4.3 cc lubricant /100 h. After two months, the perma PRO indicates aremaining volume (RV) of 75 % Vol. At this point, the lubricator is switched off for six weeks (e.g. machinestandstill). When it is switched on again, you would like to determine when the PRO LC-unit will be empty.R DP =100RV*SDP=10075*8=100600= 6This results in a remaining discharge period of six months. After these six months, the PRO LC-unit will beempty and must be replaced by a new one.c)♦Push the PRO LC-unit into the protection cover until lubricant comes out of the opening(refer to figure 6).Figure 6d)♦Place the PRO LC-unit with its protection cover on the drive-unit. Make sure that the catch locks andthat the teeth of the PRO LC-unit and the drive unit interlock (refer to figure 4 and figure 7).♦Turn the cover clockwise until the bayonet catch locks.F igure 7。
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I(Acts whose publication is obligatory)DIR ECTIVE 98/37/EC OF THE EUR OPEAN PAR LIAMENT AND OF THE COUNCILof 22 June 1998on the approximation of the laws of the Member States relating to machineryTHE EUROPEAN PARL IAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the Economic and Social Committee(1),Acting in accordance with the procedure laid down in Article 189b of the Treaty(2),(1)Whereas Council Directive 89/392/EEC of 14 June1989 on the approximation of the laws of theMember States relating to machinery(3) has beenfrequently and substantially amended; whereas forreasons of clarity and rationality the said Directiveshould be consolidated;(2)Whereas the internal market consists of an areawithout internal frontiers within which the freemovement of goods, persons, services and capital isguaranteed;(3)Whereas the machinery sector is an important partof the engineering industry and is one of theindustrial mainstays of the Community economy;(4)Whereas the social cost of the large number ofaccidents caused directly by the use of machinerycan be reduced by inherently safe design and(1)OJ C 133, 28.4.1997, p. 6.(2)Opinion of the European Parliament of 17 September 1997(OJ C 304, 6.10.1997, p. 79), Council common position of24 March 1998 (OJ C 161, 27.5.1998, p. 54) and Decisionof the European Parliament of 30 April 1998 (OJ C 152,18.5.1998). Council Decision of 25 May 1998.(3)OJ L 183, 29.6.1989, p. 9. Directive as last amended byDirective 93/68/EEC (OJ L 220, 30.8.1993, p. 1).construction of machinery and by proper installations and maintenance;(5)Whereas Member States are responsible forensuring the health and safety on their territory of persons and, where appropriate, of domestic animals and goods and, in particular, of workers, notably in relation to the risks arising out of the use of machinery;(6)Whereas, in the Member States, the legislativesystems regarding accident prevention are very different; whereas the relevant compulsory provisions, frequently supplemented by de facto mandatory technical specifications and/or voluntary standards, do not necessarily lead to different levels of health and safety, but nevertheless, owing to their disparities, constitute barriers to trade within the Community; whereas, furthermore, conformity certification and national certification systems for machinery differ considerably;(7)Whereas existing national health and safetyprovisions providing protection against the risks caused by machinery must be approximated to ensure free movement on the market of machinery without lowering existing justified levels of protection in the Member States; whereas the provisions of this Directive concerning the design and construction of machinery, essential for a safer working environment, shall be accompanied by specific provisions concerning the prevention of certain risks to which workers can be exposed at work, as well as by provisions based on the organisation of safety of workers in the working environment;(8)Whereas Community law, in its present form,provides — by way of derogation from one of the fundamental rules of the Community, namely the free movement of goods — that obstacles tomovement within the Community resulting fromdisparities in national legislation relating to themarketing of products must be accepted in so far asthe provisions concerned can be recognised as beingnecessary to satisfy imperative requirements;(9)Whereas paragraphs 65 and 68 of the White Paperon the completion of the internal market, approvedby the European Council in June 1985, provide fora new approach to legislative harmonisation;whereas, therefore, the harmonisation of laws inthis case must be limited to those requirementsnecessary to satisfy the imperative and essentialhealth and safety requirements relating tomachinery; whereas these requirements mustreplace the relevant national provisions becausethey are essential;(10)Whereas the maintenance or improvement of thelevel of safety attained by the Member Statesconstitutes one of the essential aims of thisDirective and of the principle of safety as definedby the essential requirements;(11)Whereas the field of application of this Directivemust be based on a general definition of the term‘machinery’ so as to allow the technicaldevelopment of products; whereas the developmentof complex installations and the risks they involveare of an equivalent nature and their expressinclusion in the Directive is therefore justified; (12)Whereas it is also necessary to deal with safetycomponents which are placed on the marketseparately and the safety function of which isdeclared by the manufacturer or his authorisedrepresentative established in the Community; (13)Whereas, for trade fairs, exhibitions, etc., it mustbe possible to exhibit machinery which does notconform to this Directive; whereas, however,interested parties should be properly informed thatthe machinery does not conform and cannot bepurchased in that condition;(14)Whereas the essential health and safetyrequirements must be observed in order to ensurethat machinery is safe; whereas these requirementsmust be applied with discernment to take accountof the state of the art at the time of constructionand of technical and economic requirements; (15)Whereas the putting into service of machinerywithin the meaning of this Directive can relate onlyto the use of the machinery itself as intended by themanufacturer; whereas this does not preclude thelaying-down of conditions of use external to themachinery, provided that it is not thereby modifiedin a way not specified in this Directive;(16)Whereas it is necessary not only to ensure the freemovement and putting into service of machinerybearing the ‘CE’ marking and having an ECconformity certificate but also to ensure freemovement of machinery not bearing the ‘CE’marking where it is to be incorporated into othermachinery or assembled with other machinery toform a complex installation;(17)Whereas, therefore, this Directive defines only theessential health and safety requirements of generalapplication, supplemented by a number of morespecific requirements for certain categories ofmachinery; whereas, in order to help manufacturersto prove conformity to these essential requirementsand in order to allow inspection for conformity tothe essential requirements, it is desirable to havestandards harmonised at European level for theprevention of risks arising out of the design andconstruction of machinery; whereas these standardsharmonised at European level are drawn up byprivate-law bodies and must retain theirnon-binding status; whereas for this purpose theEuropean Committee for Standardisation (CEN)and the European Committee for ElectrotechnicalStandardisation (Cenelec) are the bodies recognisedas competent to adopt harmonised standards inaccordance with the general guidelines forcooperation between the Commission and thesetwo bodies signed on 13 November 1984; whereas,within the meaning of this Directive, a harmonisedstandard is a technical specification (Europeanstandard or harmonisation document) adopted byeither or both of these bodies, on the basis of aremit from the Commission in accordance with theprovisions of Directive 83/189/EEC(1) and on thebasis of general guidelines referred to above; (18)Whereas it was found necessary to improve thelegislative framework in order to ensure an effectiveand appropriate contribution by employers andemployees to the standardisation process;(19)Whereas the Member States’ responsibility forsafety, health and the other aspects covered by theessential requirements on their territory must berecognised in a safeguard clause providing foradequate Community protection procedures;(1)Council Directive 83/189/EEC of 28 March 1983 layingdown a procedure for the provision of information in the field of technical standards and regulations (OJ L 109,26.4.1983, p. 8). Directive as last amended by CommissionDecision 96/139/EC (OJ L 32, 10.2.1996, p. 31).(20)Whereas, as is currently the practice in MemberStates, manufacturers should retain theresponsibility for certifying the conformity of theirmachinery to the relevant essential requirements;whereas conformity to harmonised standardscreates a presumption of conformity to the relevantessential requirements; whereas it is left to the solediscretion of the manufacturer, where he feels theneed, to have his products examined and certifiedby a third party;(21)Whereas, for certain types of machinery having ahigher risk factor, a stricter certification procedureis desirable; whereas the EC type-examinationprocedure adopted may result in an EC declarationbeing given by the manufacturer without anystricter requirement such as a guarantee of quality,EC verification or EC supervision;(22)Whereas it is essential that, before issuing an ECdeclaration of conformity, the manufacturer orhis authorised representative established in theCommunity should provide a technical constructionfile; whereas it is not, however, essential that alldocumentation be permanently available in amaterial manner, but it must be made availableon demand; whereas it need not include detailedplans of the sub-assemblies used in manufacturingthe machines, unless knowledge of these isindispensable in order to ascertain conformity withessential safety requirements;(23)Whereas, in its communication of 15 June 1989 ona global approach to certification and testing(1), theCommission proposed that common rules be drawnup concerning a ‘CE’ conformity marking with asingle design; whereas, in its resolution of21 December 1989 on a global approach toconformity assessment(2), the Council approved asa guiding principle the adoption of a consistentapproach such as this with regard to the use of the‘CE’ marking; whereas the two basic elements ofthe new approach which must be applied aretherefore the essential requirements and theconformity assessment procedures;(24)Whereas the addressees of any decision taken underthis Directive must be informed of the reasons forsuch a decision and the legal remedies open tothem;(25)Whereas this Directive must not affect theobligations of the Member States concerning thedeadlines for transposition and application of theDirectives set out in Annex VIII, part B,(1)OJ C 231, 8.9.1989, p. 3, and OJ C 267, 19.10.1989,p. 3.(2)OJ C 10, 16.1.1990, p. 1.HAVE ADOPTED THIS DIRECTIVE:CHAPTER ISCOPE, PLACING ON THE MAR KET AND FR EEDOM OFMOVEMENTArticle 11.This Directive applies to machinery and lays down the essential health and safety requirements therefor, as defined in Annex I.It shall also apply to safety components placed on the market separately.2.For the purposes of this Directive:(a)‘machinery’ means:—an assembly of linked parts or components, at least one of which moves, with the appropriateactuators, control and power circuits, etc., joinedtogether for a specific application, in particularfor the processing, treatment, moving orpackaging of a material,—an assembly of machines which, in order to achieve the same end, are arranged andcontrolled so that they function as an integralwhole,—interchangeable equipment modifying the function of a machine, which is placed on themarket for the purpose of being assembled with amachine or a series of different machines or witha tractor by the operator himself in so far as thisequipment is not a spare part or a tool;(b)‘safety components’ means a component, providedthat it is not interchangeable equipment, which the manufacturer or his authorised representative established in the Community places on the market to fulfil a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons.3.The following are excluded from the scope of this Directive:—machinery whose only power source is directly applied manual effort, unless it is a machine used for lifting or lowering loads,—machinery for medical use used in direct contact with patients,—special equipment for use in fairgrounds and/or amusement parks,—steam boilers, tanks and pressure vessels,—machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity,—radioactive sources forming part of a machine,—firearms,—storage tanks and pipelines for petrol, diesel fuel, inflammable liquids and dangerous substances,—means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or on road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, on public road or rail networks or on water. Vehicles used in the mineral extraction industry shall not be excluded,—seagoing vessels and mobile offshore units together with equipment on board such vessels or units,—cableways, including funicular railways, for the public or private transportation of persons,—agricultural and forestry tractors, as defined in Article 1(1) of Directive 74/150/EEC(1),—machines specially designed and constructed for military or police purposes,—lifts which permanently serve specific levels of buildings and constructions, having a car moving between guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and designed for the transport of:(i)persons;(ii)persons and goods;(iii)goods alone if the car is accessible, that is to say,a person may enter it without difficulty, andfitted with controls situated inside the car orwithin reach of a person inside,—means of transport of persons using rack and pinion rail mounted vehicles,(1)Council Directive 74/150/EEC of 4 March 1974 on theapproximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors (OJ L 84, 28.3.1974, p. 10). Directive as last amended by Decision 95/1/EC, Euratom, ECSC (OJ L 1.1.1995, p. 1).—mine winding gear,—theatre elevators,—construction site hoists intended for lifting persons or persons and goods.4.Where, for machinery or safety components, the risks referred to in this Directive are wholly or partly covered by specific Community Directives, this Directive shall not apply, or shall cease to apply, in the case of such machinery or safety components and of such risks on the implementation of these specific Directives.5.Where, for machinery, the risks are mainly of electrical origin, such machinery shall be covered exclusively by Directive 73/23/EEC(2).Article 21.Member States shall take all appropriate measures to ensure that machinery or safety components covered by this Directive may be placed on the market and put into service only if they do not endanger the health or safety of persons and, where appropriate, domestic animals or property, when properly installed and maintained and used for their intended purpose.2.This Directive shall not affect Member States’entitlement to lay down, in due observance of the Treaty, such requirements as they may deem necessary to ensure that persons and in particular workers are protected when using the machinery or safety components in question, provided that this does not mean that the machinery or safety components are modified in a way not specified in the Directive.3.At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of machinery or safety components which do not conform to the provisions of this Directive, provided that a visible sign clearly indicates that such machinery or safety components do not conform and that they are not for sale until they have been brought into conformity by the manufacturer or his authorised representative established in the Community. During demonstrations, adequate safety measures shall be taken to ensure the protection of persons.(2)Council Directive 73/23/EEC of 19 February 1973 on theharmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (OJ L 77, 26.3.1973, p. 29). Directive as last amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1).Article 3Machinery and safety components covered by this Directive shall satisfy the essential health and safety requirements set out in Annex I.Article 41.Member States shall not prohibit, restrict or impede the placing on the market and putting into service in their territory of machinery and safety components which comply with this Directive.2.Member States shall not prohibit, restrict or impede the placing on the market of machinery where the manufacturer or his authorised representative established in the Community declares in accordance with point B of Annex II that it is intended to be incorporated into machinery or assembled with other machinery to constitute machinery covered by this Directive, except where it can function independently.‘Interchangeable equipment’, as referred to in the third indent of Article 1(2)(a), must in all cases bear the CE marking and be accompanied by the EC declaration of conformity referred to in Annex II, point A.3.Member States may not prohibit, restrict or impede the placing on the market of safety components as defined in Article 1(2) where they are accompanied by an EC declaration of conformity by the manufacturer or his authorised representative established in the Community as referred to in Annex II, point C.Article 51.Member States shall regard the following as conforming to all the provisions of this Directive, including the procedures for checking the conformity provided for in Chapter II:—machinery bearing the CE marking and accompanied by the EC declaration of conformity referred to in Annex II, point A,—safety components accompanied by the EC declaration of conformity referred to in Annex II, point C.In the absence of harmonised standards, Member States shall take any steps they deem necessary to bring to the attention of the parties concerned the existing national technical standards and specifications which are regarded as important or relevant to the proper implementation of the essential safety and health requirements in Annex I.2.Where a national standard transposing a harmonised standard, the reference for which has been published in the Official Journal of the European Communities, covers one or more of the essential safety requirements, machinery or safety components constructed in accordance with this standard shall be presumed to comply with the relevant essential requirements.Member States shall publish the references of national standards transposing harmonised standards.3.Member States shall ensure that appropriate measures are taken to enable the social partners to have an influence at national level on the process of preparing and monitoring the harmonised standards.Article 61.Where a Member State or the Commission considers that the harmonised standards referred to in Article 5(2) do not entirely satisfy the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the committee set up under Directive 83/189/EEC, giving the reasons therefor. The committee shall deliver an opinion without delay.Upon receipt of the committee’s opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the published information referred to in Article 5(2).2. A standing committee shall be set up, consisting of representatives appointed by the Member States and chaired by a representative of the Commission.The standing committee shall draw up its own rules of procedure.Any matter relating to the implementation and practical application of this Directive may be brought before the standing committee, in accordance with the following procedure:The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account.Article 71.Where a Member State ascertains that:—machinery bearing the CE marking, or—safety components accompanied by the EC declaration of conformity,used in accordance with their intended purpose are liable to endanger the safety of persons, and, where appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such machinery or safety components from the market, to prohibit the placing on the market, putting into service or use thereof, or to restrict free movement thereof.Member States shall immediately inform the Commission of any such measure, indicating the reason for its decision and, in particular, whether non-conformity is due to: (a)failure to satisfy the essential requirements referredto in Article 3;(b)incorrect application of the standards referred to inArticle 5(2);(c)shortcomings in the standards themselves referred toin Article 5(2).2.The Commission shall enter into consultation with the parties concerned without delay. Where the Commission considers, after this consultation, that the measure is justified, it shall immediately so inform the Member State which took the initiative and the other Member States. Where the Commission considers, after this consultation, that the action is unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative established within the Community. Where the decision referred to in paragraph 1 is based on a shortcoming in the standards, and where the Member State at the origin of the decision maintains its position, the Commission shall immediately inform the committee in order to initiate the procedures referred to in Article 6(1).3.Where:—machinery which does not comply bears the CE marking,—a safety component which does not comply is accompanied by an EC declaration of conformity,the competent Member State shall take appropriate action against whom so ever has affixed the marking or drawn up the declaration and shall so inform the Commission and other Member States.4.The Commission shall ensure that Member States are kept informed of the progress and outcome of this procedure.CHAPTER IICONFOR MITY ASSESSMENT PR OCEDUR ESArticle 81.The manufacturer or his authorised representative established in the Community must, in order to certify that machinery and safety components are in conformity with this Directive, draw up for all machinery or safety components manufactured an EC declaration of conformity based on the model given in Annex II, point A or C as appropriate.In addition, for machinery alone, the manufacturer or his authorised representatives established in the Community must affix to the machine the CE marking.2.Before placing on the market, the manufacturer, or his authorised representative established in the Community, shall:(a)if the machinery is not referred to in Annex IV, drawup the file provided for in Annex V;(b)if the machinery is referred to in Annex IV and itsmanufacturer does not comply, or only partly complies, with the standards referred to in Article 5(2) or if there are no such standards, submit an example of the machinery for the EC type-examination referred to in Annex VI;(c)if the machinery is referred to in Annex IV and ismanufactured in accordance with the standards referred to in Article 5(2):—either draw up the file referred to in Annex VI and forward it to a notified body, which willacknowledge receipt of the file as soon aspossible and keep it,—submit the file referred to in Annex VI to the notified body, which will simply verify that thestandards referred to in Article 5(2) have beencorrectly applied and will draw up a certificate ofadequacy for the file,—or submit the example of the machinery for the EC type-examination referred to in Annex VI.3.Where the first indent of paragraph 2(c) of this Article applies, the provisions of the first sentence of paragraphs 5 and 7 of Annex VI shall also apply.Where the second indent of paragraph 2(c) of this Article applies, the provisions of paragraphs 5, 6 and 7 of Annex VI shall also apply.4.Where paragraph 2(a) and the first and second indents of paragraph 2(c) apply, the EC declaration of conformity shall solely state conformity with the essential requirements of the Directive.Where paragraph 2(b) and the third indent of paragraph 2(c) apply, the EC declaration of conformity shall state conformity with the example that underwent EC type-examination.5.Safety components shall be subject to the certification procedures applicable to machinery pursuant to paragraphs 2, 3 and 4. Furthermore, during EC type-examination, the notified body shall verify the suitability of the safety component for fulfilling the safety functions declared by the manufacturer.6.(a)Where the machinery is subject to otherDirectives concerning other aspects and whichalso provide for the affixing of the CE marking,the latter shall indicate that the machinery is alsopresumed to conform to the provisions of thoseother Directives.(b)However, where one or more of those Directivesallow the manufacturer, during a transitionalperiod, to choose which arrangements to apply,the CE marking shall indicate conformity only tothe Directives applied by the manufacturer. In thiscase, particulars of the Directives applied, aspublished in the Official Journal of the EuropeanCommunities, must be given in the documents,notices or instructions required by the directivesand accompanying such machinery.7.Where neither the manufacturer nor his authorised representative established in the Community fulfils the obligations of paragraphs 1 to 6, these obligations shall fall to any person placing the machinery or safety component on the market in the Community. The same obligations shall apply to any person assembling machinery or parts thereof or safety components of various origins or constructing machinery or safety components for his own use.8.The obligations referred to in paragraph 7 shall not apply to persons who assemble with a machine or tractor interchangeable equipment as provided for in Article 1, provided that the parts are compatible and each of the constituent parts of the assembled machine bears the CE marking and is accompanied by the EC declaration of conformity.Article 91.Member States shall notify the Commission and the other Member States of the approved bodies which they have appointed to carry out the procedures referred to in Article 8 together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.2.Member States shall apply the criteria laid down in Annex VII in assessing the bodies to be indicated in such notification. Bodies meeting the assessment criteria laid down in the relevant harmonised standards shall be presumed to fulfil those criteria.3. A Member State which has approved a body must withdraw its notification if it finds that the body no longer meets the criteria referred to in Annex VII. It shall immediately inform the Commission and the other Member States accordingly.CHAPTER IIICE MAR KINGArticle 101.The CE conformity marking shall consist of the initials ‘CE’. The form of the marking to be used is shown in Annex III.2.The CE marking shall be affixed to machinery distinctly and visibly in accordance with point 1.7.3 of Annex I.3.The affixing of markings on the machinery which are likely to deceive third parties as to the meaning and form of the CE marking shall be prohibited. Any other marking may be affixed to the machinery provided that the visibility and legibility of the CE marking is not thereby reduced.。