Annex4
Toebvh认证

生命是永恒不断的创造,因为在它内部蕴含着过剩的精力,它不断流溢,越出时间和空间的界限,它不停地追求,以形形色色的自我表现的形式表现出来。
--泰戈尔认证百科名片认证,按照国际标准化组织(ISO)和国际电工委员会(IEC)的定义,是指由国家认可的认证机构证明一个组织的产品、服务、管理体系符合相关标准、技术规范(TS)或其强制性要求的合格评定活动。
目录定义中国认证机构分类计算机认证机械CE认证定义中国认证机构分类计算机认证机械CE认证定义工作和生活中,我们经常遇到“认证”二字,但是很多人并不十分清楚什么是认证。
作为质量管理体系(Q MS)高级审核员、环境管理体系(EMS)审核员、职业健康安全管理体系(OHSMS)高级审核员,我原意向大家介绍一些这方面的知识,希望能够对大家有所帮助。
认证是指由认证机构证明产品、服务、管理体系符合相关技术规范、相关技术规范的强制性要求或者标准的合格评定活动。
此处的认证包括体系认证和产品认证两大类,体系认证一般的企业都可以做,也是一个让客户对自己的企业或公司放心的认证,比如说ISO9001质量体系认证,一般价格以企业或公司人数的多少来决定;产品认证相对来说比较广泛,各种不同规格的产品和不同的产品认证价格都不一样,当然他们的用途也不一样,比如说CCC国家强制性认证和CE欧盟安全认证。
另外,同一类产品做不同的产品认证价格也不相同,比如说空调,如果出口的话就要做国外的相关产品认证。
认证的作用1.指导消费者选购满意的商品2.给销售者带来信誉和更多的利润3.帮助生产企业建立健全存效的质量体系4.节约大量检验费用5.国家可以将推行产品认证制度作为提高产品质量的重要手段6.实行强制性的安全认证制度是国家保护消费者人身安全和健康的有效手段7.提高产品在国际市场上的竞争能力中国认证机构中国认证机构认可机构是中国合格评定国家认可中心(CNAS),CNAS由原中国认证机构国家认可委员会(CNAB)和中国实验室国家认可委员会(CNAL)合并而来。
ECE R6-2001

*/Former title of the Agreement:Agreement Concerning the Adoption of Uniform Conditions of Approval and Reciprocal Recognition of Approval for Motor Vehicle Equipment and Parts, done at Geneva on 20 March 1958.GE.01-E/ECE/324 Add.5/Rev.3E/ECE/TRANS/505A10 July 2001AGREEMENTCONCERNING THE ADOPTION OF UNIFORM TECHNICAL PRESCRIPTIONSFOR WHEELED VEHICLES, EQUIPMENT AND PARTS WHICH CAN BE FITTED AND/ORBE USED ON WHEELED VEHICLES AND THE CONDITIONS FOR RECIPROCAL RECOGNITIONOF APPROVALS GRANTED ON THE BASIS OF THESE PRESCRIPTIONS */(Revision 2, including the amendments entered into force on 16 October 1995)__________Addendum 5: Regulation No. 6Revision 3Incorporating all valid text up to:Supplement 4 to the 01 series of amendments - Date of entry into force: 2 December 1992Supplement 5 to the 01 series of amendments - Date of entry into force: 13 January 1993Corrigendum 2 to the 01 series of amendments subject of depositary notification C.N.115.1992.TREATIES-11 dated 1 July 1992Supplement 6 to the 01 series of amendments - Date of entry into force: 11 February 1996Supplement 7 to the 01 series of amendments - Date of entry into force: 3 September 1997Supplement 8 to the 01 series of amendments - Date of entry into force: 24 July 2000Supplement 9 to the 01 series of amendments - Date of entry into force: 26 December 2000UNIFORM PROVISIONS CONCERNING THE APPROVAL OF DIRECTION INDICATORSFOR MOTOR VEHICLES AND THEIR TRAILERS__________UNITED NATIONSE/ECE/324Add.5/Rev.3E/ECE/TRANS/505ARegulation No. 6page 3Regulation No. 6UNIFORM PROVISIONS CONCERNING THE APPROVAL OF DIRECTION INDICATORSFOR MOTOR VEHICLES AND THEIR TRAILERSCONTENTSREGULATION Page1.Definitions (5)2.Application for approval (5)3.Markings (6)4.Approval (6)5.General specifications (9)6.Intensity of light emitted (9)7.Test procedure (12)8.Colour of light emitted (13)9.Modifications of a type of direction indicatorfor motor vehicles and their trailers andextension of approval (13)10.Conformity of production (13)11.Penalties for non-conformity of production (14)12.Production definitely discontinued (14)s and addresses of technical servicesresponsible for conducting approval tests,and of administrative departments (14)14.Transitional provisions (14)E/ECE/324Add.5/Rev.3E/ECE/TRANS/505ARegulation No. 6page 4ANNEXESAnnex 1 -Categories of direction indicators: Minimum angles required for light distribution in space of these categories of directionindicatorsAnnex 2 -Communication concerning the approval or extension or refusal or withdrawal of approval or production definitely discontinued of atype of direction indicator pursuant to Regulation No. 6Annex 3 -Arrangement of the approval markAnnex 4 -Photometric measurementsAnnex 5 -Colour of amber lights - Trichromatic co-ordinatesAnnex 6 -Minimum requirements for conformity of production controlproceduresAnnex 7 -Minimum requirements for sampling by an inspector* * *E/ECE/324Add.5/Rev.3E/ECE/TRANS/505ARegulation No. 6page 51.DEFINITIONSFor the purposes of this Regulation:1.1."Direction indicator" means a device mounted on a motor vehicle ortrailer which, when operated by the driver, signals the latter'sintention to change the direction in which the vehicle isproceeding. The present Regulation applies solely tofixed-position flashing light devices whose flashing is obtainedby the intermittent supply of electric current to the lamp.1.2.The definitions given in Regulation No. 48 and its series ofamendments in force at the time of application for type approvalshall apply to this Regulation.1.3."Direction indicators of different 'types'" are differentindicators which differ in such essential respects as:The trade name or mark,The characteristics of the optical system (levels of intensity,light distribution angles, etc.),The category of direction indicators,The colour of the filament lamp.2.APPLICATION FOR APPROVAL2.1.The application for approval of a type of direction indicatorshall be submitted by the holder of the trade name or mark or byhis duly accredited representative. It shall specify to whichcategory or to which of the categories 1, 1a, 1b, 2a, 2b, 3, 4, 5or 6 according to annex 1, the direction indicator belongs and, ifit belongs to category 2, whether it has one level of intensity(category 2a) or two levels of intensity (category 2b) and whetherthe direction indicator may also be used in an assembly of twolamps of the same category.2.2.For each type of direction indicator the application shall beaccompanied by the following:2.2.1.Drawings, in triplicate, sufficiently detailed to permitidentification of the type and category and showing geometricallyin what position the direction indicator is mounted on thevehicle; the axis of observation to be taken as the axis ofreference in the tests (horizontal angle H = O°, vertical angleV = 0°); and the point to be taken as the centre of reference inthe said tests. The drawings shall show the position intended forthe approval number and the additional symbols in relation to thecircle of the approval mark;2.2.2. A brief technical description stating in particular the categoriesof filament lamps prescribed, with the exception of lamps withnon-replaceable light sources; each filament lamp category shallbe one or other of those contained in Regulation No. 37;E/ECE/324Add.5/Rev.3E/ECE/TRANS/505ARegulation No. 6page 62.2.3.For a direction indicator of category 2b, an arrangement diagramand a specification of the characteristics of the system ensuringthe two levels of intensity;2.2.4.Two samples; if the approval is applied for devices which are notidentical but are symmetrical and suitable for mounting one on theleft and one on the right side of the vehicle, the two samplessubmitted may be identical and be suitable for mounting only onthe right or only on the left side of the vehicle; for adirection indicator of category 2b, the application shall also beaccompanied by two samples of the parts constituting the systemwhich ensures the two levels of intensity.3.MARKINGSDevices submitted for approval shall:3.1.bear the trade name or mark of the applicant; this marking shallbe clearly legible and indelible;3.2.bear a clearly legible and indelible marking indicating thecategory or categories of filament lamps prescribed; this is notvalid for lamps with non-replaceable light sources;prise a space of sufficient size for the approval marking andthe additional symbols prescribed in paragraph 4.2. below; thisspace shall be shown in the drawings mentioned in paragraph 2.2.1.above;3.4.in the case of lamps with non-replaceable light sources, bear themarking of rated voltage and rated wattage.4.APPROVAL4.1.General4.1.1.If the two devices submitted for approval in pursuance ofparagraph 2.2.4. above meet the requirements of this Regulation,approval shall be granted.4.1.2.Where grouped, combined or reciprocally incorporated lamps havebeen found to comply with the requirements of several Regulationsannexed to the 1958 Agreement, a single international approvalmark may be applied provided that such lamps are not grouped,combined or reciprocally incorporated with a lamp or lamps notsatisfying any one of these Regulations.4.1.3.An approval number shall be assigned to each type approved. Itsfirst two digits (at present 01, corresponding to the 01 series ofamendments which entered into force on 27 June 1987) shallindicate the series of amendments incorporating the most recentmajor technical amendments made to the Regulation at the time ofissue of the approval. The same Contracting Party shall notassign the same number to another type of device covered by thisRegulation. Direction indicators of different categories may bemarked with a single approval number when they form one assembly.E/ECE/324 Add.5/Rev.3E/ECE/TRANS/505ARegulation No. 6page 71/ 1 for Germany, 2 for France, 3 for Italy, 4 for the Netherlands,5 for Sweden, 6 for Belgium, 7 for Hungary, 8 for the Czech Republic, 9 for Spain, 10 for Yugoslavia, 11 for the United Kingdom, 12 for Austria, 13 for Luxembourg, 14 for Switzerland, 15 (vacant), 16 for Norway, 17 for Finland,18 for Denmark, 19 for Romania, 20 for Poland, 21 for Portugal, 22 for the Russian Federation, 23 for Greece, 24 for Ireland, 25 for Croatia, 26 for Slovenia, 27 for Slovakia, 28 for Belarus, 29 for Estonia, 30 (vacant), 31 for Bosnia and Herzegovina, 32 for Latvia, 33 (vacant), 34 for Bulgaria,35-36 (vacant), 37 for Turkey, 38-39 (vacant), 40 for The former Yugoslav Republic of Macedonia, 41 (vacant), 42 for the European Community (Approvals are granted by its Member States using their respective ECE symbol), 43 for Japan, 44 (vacant), 45 for Australia, 46 for Ukraine and 47 for South Africa. Subsequent numbers shall be assigned to other countries in the chronological order in which they ratify or accede to the Agreement Concerning the Adoption of Uniform Technical Prescriptions for Wheeled Vehicles, Equipment and Parts which can be Fitted and/or be Used on Wheeled Vehicles and the Conditions for Reciprocal Recognition of Approvals Granted on the Basis of these Prescriptions, and the numbers thus assigned shall be communicated by the Secretary-General of the United Nations to the Contracting Parties to the Agreement.4.1.4.Notice of approval or of extension or refusal or withdrawal ofapproval or production definitely discontinued of a type of devicepursuant to this Regulation shall be communicated to the Partiesto the 1958 Agreement which apply this Regulation, by means of aform conforming to the model in annex 2 to this Regulation.4.1.5.Every device conforming to a type approved under this Regulationshall bear in the space referred to in paragraph 3.3. above, andin addition to the markings prescribed in paragraphs 3.1. and 3.2.or 3.4. respectively, an approval mark as described inparagraphs 4.2. and 4.3. below.position of the approval markThe approval mark shall consist of:4.2.1.an international approval marking, comprising 4.2.1.1.A circle surrounding the letter "E" followed by the distinguishing number of the country which has granted approval; 1/ 4.2.1.2.The approval number prescribed in paragraph 4.1.3. above.4.2.2.The following additional symbol (or symbols):4.2.2.1.One or more of the numbers: 1, 1a, 1b, 2a, 2b, 3, 4, 5 or 6,according to whether the device belongs to one or more categories1, 1a, 1b, 2a, 2b, 3, 4, 5 or 6 for which approval is sought inaccordance with paragraph 2.1;4.2.2.2.On devices which cannot be mounted on either side of the vehicle indiscriminately, a horizontal arrow showing in which position the device is to be mounted (the arrow shall be directed outwards from the vehicle in the case of devices of categories 1, 1a, 1b, 2a and 2b and towards the front of the vehicle in the case of devices of categories 3, 4, 5 and 6). In addition, for devices of category 6E/ECE/324Add.5/Rev.3E/ECE/TRANS/505ARegulation No. 6page 8an indication "R" or "L" shall in this case be shown on thedevice, indicating the right or left side of the vehicle.4.2.2.3.On devices which may be used as part of an assembly of two lamps,the additional letter "D" to the right side of the symbolmentioned in paragraph 4.2.2.1.;4.2.2.4.On devices with reduced light distribution in conformity toparagraph 2.1.3. of annex 4 to this Regulation a vertical arrowstarting from a horizontal segment and directed downwards.4.2.2.5.The two digits of the approval number which indicate the series ofamendments in force at the time of issue of the approval and, ifnecessary, the required arrow may be marked close to the aboveadditional symbols;4.2.2.6.The marks and symbols referred to in paragraphs 4.2.1. and 4.2.2.above shall be clearly legible and be indelible even when thedevice is fitted in the vehicle.4.3.Arrangement of the approval mark4.3.1.Independent lampsAnnex 3, figure 1, to this Regulation gives an example ofarrangement of the approval mark with the above-mentionedadditional symbols.4.3.2.Grouped, combined or reciprocally incorporated lamps4.3.2.1.Where grouped, combined or reciprocally incorporated lamps havebeen found to comply with the requirements of several Regulations,a single international approval mark may be applied consisting ofa circle surrounding the letter "E" followed by the distinguishingnumber of the country which has granted the approval, and anapproval number. This approval mark may be located anywhere onthe grouped, combined or reciprocally incorporated lamps, providedthat:4.3.2.1.1.it is visible after the installation of the lamps;4.3.2.1.2.no part of the grouped, combined or reciprocally incorporatedlamps that transmits light can be removed without at the same timeremoving the approval mark.4.3.2.2.an identification symbol for each lamp appropriate to eachRegulation under which approval has been granted, together withthe corresponding series of amendments incorporating the mostrecent major technical amendments to the Regulation at the time ofissue of the approval and, if necessary, the required arrow shallbe marked:4.3.2.2.1.either on the appropriate light-emitting surface;4.3.2.2.2.or in a group, in such a way that each lamp of the grouped,combined or reciprocally incorporated lamps may be clearlyE/ECE/324Add.5/Rev.3E/ECE/TRANS/505ARegulation No. 6page 9identified.4.3.2.3.The size of the components of a single approval mark shall not beless than the minimum size required for the smallest of theindividual marks by the Regulation under which approval has beengranted.4.3.2.4.An approval number shall be assigned to each type approved. Thesame Contracting Party may not assign the same number to anothertype of grouped, combined or reciprocally incorporated lampscovered by this Regulation.4.3.2.5.Annex 3, figure 2, to this Regulation gives examples of thearrangement of the approval marks for grouped, combined orreciprocally incorporated lamps with all the above-mentionedadditional symbols.mps reciprocally incorporated with other lamps, of which thelens may also be used for other types of headlampsThe provisions laid down in paragraph 4.3.2. above are applicable.4.3.3.1.In addition, where the same lens is used, the latter may bear thedifferent approval marks relating to the different types ofheadlamps or units of lamps, provided that the main body of theheadlamp, even if it cannot be separated from the lens, alsocomprises the space described in paragraph 3.3. above and bearsthe approval marks of the actual functions.If different types of headlamps comprise the same main body, thelatter may bear the different approval marks.4.3.3.2.Annex 3, figure 3, to this Regulation gives examples of approvalmarks for lamps reciprocally incorporated with a headlamp.4.4.The approval marking shall be clearly legible and indelible. Itmay be placed on an inner or outer part (transparent or not) ofthe device which cannot be separated from the transparent part ofthe device emitting the light. In any case the marking shall bevisible when the device is fitted on the vehicle or when a movablepart such as the hood or boot lid or a door is opened.5.GENERAL SPECIFICATIONS5.1.Each device supplied shall conform to the specifications set forthin paragraphs 6. and 8. below.5.2.The devices must be so designed and constructed that under normalconditions of use and notwithstanding the vibrations to which theymay be subjected in such use, their satisfactory operation remainsassured and they retain the characteristics prescribed by thisRegulation.E/ECE/324Add.5/Rev.3E/ECE/TRANS/505ARegulation No. 6page 106.INTENSITY OF LIGHT EMITTED6.1.The light emitted by each of the two devices supplied must be inthe case of direction indicators of categories 1, 1a, 1b, 2a, 2b,3 or4 in the reference axes, in the case of direction indicatorsof categories 5 or 6 in direction A according to annex 1 of notless than the minimum intensity and of not more than the maximumintensity specified below:E/ECE/324Add.5/Rev.3E/ECE/TRANS/505A Regulation No. 6page 112/The installation of front direction indicators of the variouscategories in power-driven vehicles and their trailers is provided for in the Regulations concerning the installation of lighting and light-signalling devices (Regulations Nos. 48 and 53).3/The total value of maximum intensity for an assembly of two lamps isgiven by multiplying by 1.4 the value prescribed for a single lamp.When an assembly of two lamps having the same function is deemed to be,for the purpose of installation on a vehicle, a "single lamp" (following the definition of Regulation No. 48 and its series of amendments in force at the time of application for type approval) each individual lamp constituting the "single lamp" shall comply with the minimum intensity required and the two lamps together shall not exceed the admissible maximum intensity (last column of the table).In the case of a single lamp containing more than one light source:the lamp shall comply with the minimum intensity required when any one light source has failed,however, for front or rear direction indicator lamps 50 per cent of the minimum intensity in the axis of reference of the lamp shall be considered sufficient, provided that a note in the communication form states that the lamp is only for use on a vehicle fitted with an operating tell-tale, which indicates when any one or more light source(s) has (have) failed, andwhen all light sources are illuminated, the maximum intensity specified for a single lamp may be exceeded, provided that the single lamp is not marked "D" and the maximum intensity specified for an assembly of two lamps (last column of the table) is not exceeded.Direction indicator 2/of category Minimum intensities cd Maximum values in cd when used asSingle lamp Lamp (single) marked "D"(see paragraph 4.2.2.3.)Total for the assembly of two lamps (see paragraph 4.2.2.3.)1175700 3/490 3/980 3/1a 250800 3/560 3/ 1 120 3/1b 400860 3/600 3/ 1 200 3/2a 503503503502b by day 175700 3/490 3/980 3/ by night 40120 3/84 3/168 3/3 towards the front 175700 3/490 3/980 3/ towards the rear 502001402804 towards the front 175700 3/490 3/980 3/ towards the rear 0.620014028050.6200140280650200140280E/ECE/324Add.5/Rev.3E/ECE/TRANS/505ARegulation No. 6page 126.2.Outside the reference axis, within the angular fields specified inthe arrangement diagrams in annex 1 to this Regulation, theintensity of the light emitted by each of the two devices suppliedmust:6.2.1.In each direction corresponding to the points in the relevanttable of luminous-intensity distribution reproduced in annex 4 tothis Regulation, be not less than the minimum specified inparagraph 6.1. above multiplied by the percentage specified in thesaid table for the direction in question;6.2.1.1.In divergence from paragraphs 6.2. and 6.2.1., for categories 4and 5 direction indicators, to the rear, a minimum value of 0.6 cdis required throughout the fields specified in annex 1;6.2.2.In no direction within the area from which the indicator lamp isvisible, exceed the maximum specified in paragraph 6.1. above;6.2.3.Moreover,6.2.3.1.Throughout the fields defined in the diagrams in annex 1, theintensity of the light emitted must be not less than 0.7 cd fordevices of category 1b, not less than 0.3 cd for devices ofcategories 1, 1a, 2a, 3, 4 towards the front and for those ofcategory 2b by day; it shall not be less than 0.07 cd for devicesof category 2b by night;6.2.3.2.For devices of categories 1 and 2b by night and, to the front, fordevices of categories 3 and 4, the intensity of the light emittedoutside the zone defined by the measuring points + 10°H and +10°V (10°-field) must not exceed the following values:Direction indicator of categoryMaximum values in cd outside the 10°-fieldSingle lamp Lamp (single)marked "D" (seeparagraph 4.2.2.3.)Total for theassembly of twolamps (seeparagraph 4.2.2.3.)2b by night 100 70 1401, 3 and 4 400 280 560Between the boundaries of the 10°-field (+ 10°H and + 10°V) andthe 5°-field (± 5°H and ± 5°V), the maximum admissible values ofthe intensities are linearly increased up to the values as definedin paragraph 6.1.;6.2.3.3.For devices of category 1a and 1b, the intensity of the lightemitted outside the zone defined by the measuring points + 15°Hand + 15°V (15°-field) shall not exceed the following values:E/ECE/324Add.5/Rev.3 E/ECE/TRANS/505ARegulation No. 6page 13Direction indicator of categoryMaximum values in cd outside the 15°-field Single lamp Lamp (single)marked "D"(see paragraph4.2.2.3.)Total for the assemblyof two lamps (seeparagraph 4.2.2.3.)1a2501753501b400280560Between the boundaries of the 15°-field (+ 15°H and + 15°V) andthe 5°-field (+ 5°H and + 5°V), the maximum values are increasedlinearly up to the values as defined in paragraph 6.1.6.2.3.4.The provisions of paragraph 2.2. of annex 4 to this Regulation onlocal variations of intensity must be observed.6.3.The intensities shall be measured with the filament lamp(s)continuously alight.6.4.In the case of devices of category 2b the time that elapsesbetween electrical supply being switched on and the light outputmeasured on the reference axis to reach 90 per cent of the valuemeasured in accordance with paragraph 6.3. above shall be measuredfor both the day and the night conditions of use. The timemeasured for the night condition of use shall not exceed thatmeasured for the day condition of use.6.5.Annex 4, referred to in paragraph 6.2.1. above, gives particularsof the measurement methods to be used.7.TEST PROCEDURE7.1.All measurements shall be made with an uncoloured or amber-coloured standard filament lamp of the category prescribed for thedevice, the supply voltage being so regulated as to produce thereference luminous flux prescribed for that category of lamp.7.1.1.All measurements on lamps equipped with non-replaceable lightsources (filament lamps and other) shall be made at 6.75 V, 13.5 Vor 28.0 V respectively.In the case of light sources supplied by a special power supply,the above test voltages shall be applied to the input terminals ofthat power supply. The test laboratory may require from themanufacturer the special power supply needed to supply the lightsources.E/ECE/324Add.5/Rev.3E/ECE/TRANS/505A Regulation No. 6page 144/ The functioning and installation conditions of this additionaldevice will be defined by special provisions.7.2.However, in the case of an indicator of category 2b for which an additional system 4/ is used to obtain the night-time intensity,the voltage applied to the system for measuring the night-timeintensity shall be that which was applied to the filament lamp for measuring the day-time intensity.7.3.The vertical and horizontal outlines of the illuminating surface of a light-signalling device shall be determined and measured in relation to the centre of reference.8.COLOUR OF LIGHT EMITTEDThe colour of the light emitted inside the field of the light distribution grid defined in paragraph 2 of annex 4 shall bewithin the limits of the coordinates prescribed in annex 5 to this Regulation. Outside this field, no sharp variation of colour shall be observed.9.MODIFICATIONS OF A TYPE OF DIRECTION INDICATOR FOR MOTOR VEHICLES AND THEIR TRAILERS AND EXTENSION OF APPROVAL9.1.Every modification of a type of direction indicator shall benotified to the administrative department which approved the type. The department may then either:9.1.1.Consider that the modifications made are unlikely to have anappreciable adverse effect and that in any case the device still complies with the requirements; or9.1.2.Require a further test report from the technical service responsible for conducting the tests.9.2.Confirmation or refusal of approval, specifying the alterations,shall be communicated by the procedure specified inparagraph 4.1.4. above to the Parties to the Agreement applying this Regulation.9.3.The competent authority issuing the extension of approval shall assign a series number for such an extension and inform thereof the other Parties to the 1958 Agreement applying this Regulation by means of a communication form conforming to the model in annex 2 to this Regulation. 10.CONFORMITY OF PRODUCTIONThe conformity of production procedures shall comply with those set out in the Agreement, Appendix 2 (E/ECE/324-E/ECE/TRANS/505/Rev.2), with the following requirements:10.1.Direction indicators approved under this Regulation shall be so manufactured as to conform to the type approved by meeting the requirements set forth in paragraphs 6 and 8 above.E/ECE/324Add.5/Rev.3E/ECE/TRANS/505ARegulation No. 6page 1510.2.The minimum requirements for conformity of production controlprocedures set forth in annex 6 to this Regulation shall becomplied with.10.3.The minimum requirements for sampling by an inspector set forth inannex 7 to this Regulation shall be complied with.10.4.The authority which has granted type approval may at any timeverify the conformity control methods applied in each productionfacility. The normal frequency of these verifications shall beonce every two years.11.PENALTIES FOR NON-CONFORMITY OF PRODUCTION11.1.The approval granted in respect of a device pursuant to thisRegulation may be withdrawn if the foregoing requirements are notmet.11.2.If a Contracting Party to the Agreement which applies thisRegulation withdraws an approval it has previously granted, itshall forthwith so notify the other Contracting Parties applyingthis Regulation, by means of a communication form conforming tothe model in annex 2 to this Regulation.12.PRODUCTION DEFINITELY DISCONTINUEDIf the holder of the approval completely ceases to manufacture adevice approved in accordance with this Regulation, he shall soinform the authority which granted the approval. Upon receivingthe relevant communication, that authority shall inform thereofthe other Parties to the 1958 Agreement applying this Regulationby means of a communication form conforming to the model inannex 2 to this Regulation.S AND ADDRESSES OF TECHNICAL SERVICES RESPONSIBLE FORCONDUCTING APPROVAL TESTS, AND OF ADMINISTRATIVE DEPARTMENTSThe Parties to the 1958 Agreement which apply this Regulationshall communicate to the United Nations Secretariat the names andaddresses of the technical services responsible for conductingapproval tests and of the administrative departments which grantapproval and to which forms certifying approval or extension orrefusal or withdrawal of approval, issued in other countries, areto be sent.14.TRANSITIONAL PROVISIONS14.1.As from the official date of entry into force of Supplement 8 tothe 01 series of amendments, no Contracting Party applying thisRegulation shall refuse to grant ECE approval under thisRegulation as amended by Supplement 8 to the 01 series ofamendments.14.2.As from 24 months after the date of entry into force, ContractingParties applying this Regulation shall grant ECE approvals only ifthe type of direction indicator to be approved meets therequirements of this Regulation as amended by Supplement 8 to the01 series of amendments.。
ECE R124 第1次修订

GE.11-AgreementConcerning the Adoption of Uniform Technical Prescriptions forWheeled Vehicles, Equipment and Parts which can be Fitted and/or be Used on Wheeled Vehicles and the Conditions for ReciprocalRecognition of Approvals Granted on the Basis of these Prescriptions *(Revision 2, including the amendments which entered into force on 16 October 1995)Addendum 123: Regulation No. 124Amendment 1Supplement 1 to the original version of the Regulation - Date of entry into force: 30 January 2011Uniform provisions concerning the approval of wheels for passenger cars andtheir trailersUNITED NATIONS* Former title of the Agreement: Agreement Concerning the Adoption of Uniform Conditions ofApproval and Reciprocal Recognition of Approval for Motor Vehicle Equipment and Parts, done at Geneva on 20 March 1958.E /ECE/324/Rev.2/Add.123/Amend.1−E /ECE/TRANS/505/Rev.2/Add.123/Amend.124 February 2011E/ECE/324/Rev.2/Add.123/Amend.1E/ECE/TRANS/505/Rev.2/Add.123/Amend.12The list of contents, amend to read:" …Annex 9 – Reserved… "The text of the RegulationParagraph 1., amend to read (including the existing footnote 1):"1. This Regulation covers new replacement wheels designed for vehicles of categories M1, M1G, N1, N1G,O1 and O21It does not apply…___________1Categories M, N, and O as defined in Annex 7 to the Consolidated Resolution on the Construction of Vehicles (R.E.3) (document TRANS/WP.29/78/Rev.1/Amend.2)."Insert a new paragraph 2.1.5., to read:"2.1.5. "PCD", means the pitch circle diameter of bolt holes."Insert a new paragraph 2.2.8., to read:"2.2.8. "Styling", the wheel’s geometric shape, including basic contour and ratio between voids and material."Paragraphs 2.4.3. and 2.4.4., amend to read:"2.4.3. "Replica … contour, dimensions, inset/outset, material…wheels;2.4.4. "Pattern … the design, inset/outset, rim designation…different." Paragraph 2.6., amend to read:"2.6. "Inset/outset /zeroset" means the distance from the attachment face of the disc to the centre line of the rim (positive for inset as shown in Figure 1below; negative for outset ; zero for zeroset)."Insert a new paragraph 2.12., to read:"2.12. "Wheel family", are in case of light alloy, wheels of the same type; however, with different inset/outset values, PCD and centre bore."Paragraph 3.1.2.2., amend to read:"3.1.2.2. rim contour designation - wheel inset/outset - wheel attachment details;" Paragraph 3.1.2.9., amend to read:"3.1.2.9. maximum load capacity at rolling circumference;"Paragraph 4.5., amend to read:"4.5. The approval mark shall be permanent, visible, and clearly legible on the outward facing side of the wheel, when the wheel is fitted on the vehicle." Paragraph 5.1.3., amend to read:"5.1.3. the wheel inset/outset (positive for inset; negative for outset);"Paragraph 5.1.5., amend to read:"5.1.5. part number of the wheel / rim (optional wheel type)."E/ECE/324/Rev.2/Add.123/Amend.1E/ECE/TRANS/505/Rev.2/Add.123/Amend.1Paragraph 6.5.2.2.(e), should be deleted.Paragraph 6.5.3.2.(e), should be deleted.Paragraph 6.6., amend to read:"6.6. Where a wheel manufacturer submits an application for type approval for awheel family, it is not necessary to carry out tests for each wheel version.Worst case selection ..."Paragraph 6.7.1, amend to read:"6.7.1. The nominal rim diameter, nominal rim width and nominal inset/outset ofECE-approved …"Insert a new paragraph 6.8., to read:"6.8. When the replacement wheel is mounted on the vehicle, the requirements ofparagraphs 5.2.1.11.2.1. or 5.2.2.8.2.1. of Regulation No. 13 orparagraph 5.2.11.2.1. of Regulation No. 13-H shall be fulfilled."Annex 1,Item 2.5., amend to read:"2.5. Wheel inset/outset:…………………………………………...………………"Item 2.7., amend to read:"2.7. Maximum wheel load and respective theoretical rolling circumference…….."Annex 3, amend the last sentence, to read:"The marking shall be at a position selected by the manufacturer. It shall be easily visibleand clearly legible after the tyre has been mounted to the wheel."Annex 4,The table, amend to read:"Material TestsAluminium alloy a, b, c, eMagnesium alloy a, b, c, eSteel a, b, d"Paragraphs (c) to (e), amend to read:"(c) Check of the material characteristics (Rp0,2 , Rm and A) of specimentaken from critical zones (such as the spoke, for example) as well asthe inner and the outer rim flange. The take-off points and position ofthe samples must be depicted in the drawing.(d) Analysis of the defects and of the new material structure.(e) Analysis of the metallurgic defects and structure taken from thetransition zone of the wheel disc and rim or from the fracture zone, ifapplicable."3E/ECE/324/Rev.2/Add.123/Amend.1E/ECE/TRANS/505/Rev.2/Add.123/Amend.14Annex 5,Paragraph 1.1., amend to read:"1.1. SamplepreparationA surface treated sample, taken from the production, shall be damaged bycross engraving (ISO 2409:2007) and stone impact (ISO 20567-1:2005) torepresent ..."Annex 6,Paragraph 2., amend to read:"2. Formula for the bending moment calculation…..d = inset/outset (positive for inset ; negative for outset) [m]…."Paragraph 3., the table, replace "M1 and M1 G" by "M1, M1 G, N1, and N1 G"Paragraph 4., amend to read:"4. Testschedulefor wheel familiesWheels of a wheel type with the same number of wheel attachment holes,same styling, different PCD and/or different inset/outset values can begrouped at the same or at a lower value of test bending moment taking intoaccount the test schedule to follow. Wheels with the largest centre holediameter shall be included in the test.In the case of a negative test, due to material failures, it can be compensatedby two positive tests of the same wheel version. If either or both of the finaltwo samples fail, then the application for approval of the replacement wheelshall be rejected.Necessarytests:…"Annex 7,Paragraph 1., amend to read:"1. TestdescriptionIn the rolling test …shall be tested.In the case of a negative test, due to material failures, it can be compensatedby two positive tests of the same wheel version. If either or both of the finaltwo samples fail, then the application for approval of the replacement wheelshall be rejected."Paragraph 3, the table, replace "M1 and M1 G" by "M1, M1 G, N1 and N1 G ."Footnote 1, amend to read:"1Only for steel disc wheels."E/ECE/324/Rev.2/Add.123/Amend.1E/ECE/TRANS/505/Rev.2/Add.123/Amend.15Annex 8,Paragraph 1., amend to read:"1. Test descriptionThe fracture behaviour of the wheel striking an object at the outer rim flangeshall be checked at critical positions. For proof of adequate fracture behaviour, an impact test according to ISO 7141:2005 shall be carried out. In the case of a negative test, due to material failures, it can be compensated by two positive tests of the same wheel version. If either or both of the final two samples fail, then the application for approval of the replacement wheel shall be rejected."Paragraph 3, amend line 1 and line 2 of the table , to read: "M 1 , N 1 , M 1 G and N 1G Procedure and requirementsISO 7141: 2005….."Paragraph 4., amend to read:"4.Tests schedule for wheel familiesWheels to be tested Impact testSmallest pitch test diameter One for each impact position Largest pitch circle diameter One for each impact positiondeviation of inset valueup to -15 mm more than -15 mm andlarger than +2 mm one for each impact position"Insert a new paragraph 5., to read: "5. Failure criteria The wheel will not pass the test if one of the following criteria applies: (a) visible incipient crack in a zone of the wheel disc of wheel assembly; (b) the centre member separates from the rim;(c)total loss of pressure within one minute.The wheel is not considered to have failed the test by deformation of thewheel assembly or by fractures in the area of a rim section struck by the face plate of the striker."Annex 8 – Appendix , should be deleted.E/ECE/324/Rev.2/Add.123/Amend.1E/ECE/TRANS/505/Rev.2/Add.123/Amend.16Annex 9, amend to read:"Annex 9Reserved"Annex 10,Paragraph 1.1., amend to read:"1.1. WheelcharacteristicsECE approval number, … and inset/outset."Paragraph 1.2., amend to read:"1.2. VehiclecharacteristicsThose vehicle characteristics should be listed that distinctly describe thevehicle type and version for which the wheel will be used. Thereby,depending on the restriction of the range of application of various marketswith respect to certain vehicle versions and variants, various specificationcharacteristics are possible.Absolutely required are the data of:(a)Vehiclemanufacturer;(b)Vehicletype:Additional optional data, e.g.:(c) Vehicle approval number; (if applicable variant/ version)(d) Engine performance (also possible range of performance).Other specification characteristics / restrictions may also be used."Paragraph 1.5., amend to read (including a new footnote 2):"1.5. Example of possible structures of the application and fitting information tableWheel characteristics (mandatory fields in bold characters)ApprovalNumberWheel TypeSize Fixing holes / pcd (mm) Inset/outset2(mm) Max. wheel load(N)6 Jx15 H2Wheel marking (Variant/Version) centeringmarkingCentering(mm)date ofmanufacture(week/year)at circumference(mm)Vehicles’ characteristics as well as additional conditions and adviceVehicle manufacturer: …….._____________2Positive for inset; negative for outsetE/ECE/324/Rev.2/Add.123/Amend.1E/ECE/TRANS/505/Rev.2/Add.123/Amend.17Fitting parts e.g. special bolts delivered by the wheel manufacturer M14x1.5, conical angle 60°, length of piston skirt xx mmVehicle Type Approval No.Performance (kW from – to) Vehicle Model namePermissible tyre size front and rear axleAdditional conditions and adviceA01)A02)A03) E01)Conditions and Advice A01) e.g. kind of balancing weights and their place of fitting; A02) e.g. kind of possible valves;A03) e.g. for using manufacturer’s replacement wheels only the standard fitting parts are allowed; E01)e.g. not allowed on 4x4 vehicles."。
WHO_TRS970_annex2(制药用水-对照版)

Annex 2 附件2WHO good manufacturing practices: water for pharmaceutical useWHO GMP:制药用水1. Introduction 介绍1.1 Scope of the document文件范围1.2 Background to water requirements and uses 水的要求和使用背景1.3 Applicable guides 适用的指南2. General principles for pharmaceutical water systems 制药用水系统的一般原则3. Water quality specifications 水质量标准3.1 General 概述3.2 Drinking-water 饮用水3.3 Bulk purified water散装纯化水3.4 Bulk highly purified water散装高纯水3.5 Bulk water for injections散装注射用水3.6 Other grades of water 其它类型水4. Application of specific types of water to processes and dosage forms 不同类型水在工艺和剂型中的应用5. Water purification systems 水纯化系统5.1 General considerations 一般考虑5.2 Production of drinking-water 饮用水的制备5.3 Production of purified water 纯化水的制备5.4 Production of highly purified water高纯水的制备5.5 Production of water for injection(s) 注射用水的制备6. Water storage and distribution systems 水存贮和分配系统6.1 General 概述6.2 Materials that come into contact with systems for water for pharmaceutical use 与制药用水系统接触的材质6.3 System sanitization and bioburden control 系统消毒和微生物控制6.4 Storage vessel requirements 贮罐要求6.5 Requirements for water distribution pipework 水分配管道要求7. Operational considerations 运行时的考虑7.1 Start-up and commissioning of water systems 水系统开机和运行7.2 Qualification 确认7.3 Continuous system monitoring 对系统的持续监控7.4 Maintenance of water systems 水系统维护7.5 System reviews 系统回顾8. Inspection of water systems 水系统检查Further reading 扩展阅读1. Introduction 介绍1.1 Scope of the document 文件范围1.1.1 The guidance contained in this document is intended to provide information about the available specifications for water for pharmaceutical use (WPU), guidance about which quality of water to use for specific applications, such as the manufacture of active pharmaceutical ingredients (APIs) and dosage forms, and to provide guidance on good manufacturing practices (GMP) regarding the design, installation and operation of pharmaceutical water systems. Although the focus of this document is on water for pharmaceutical applications, the guidelines may also be relevant to other industrial or specific uses where the specifications and practices can be applied.本文件中包括的本指南目的在于提供以下信息,关于制药用水(WPU)的可获得的质量标准,哪种质量的水适用于特定用途,例如活性药用物质(API)生产和制剂生产,提供关于药用水系统设计、安装和运行GMP指南。
靶细胞杀伤实验:AnnexiV标记法

靶细胞杀伤实验:AnnexiV标记法
正常细胞的磷酯酰丝氨(phosphatidylserine,PS)位于细胞膜内表面,细胞凋亡时翻转露于膜外侧,可与annexinV高亲合力结合。
研究发现PS外翻为细胞凋亡的早期事件,先于膜通透性增加所51Cr或其他染料的释放。
将效应细胞与靶细胞充分共育后,用PE结合的效应细胞特异性单克隆抗体(如CD8-PE)标记效应细胞(不能与PE-mABA结合的细胞即为靶细胞),再用FITC-annexin V标记凋亡靶细胞,用流式细胞仪区分并定量此三类不同的细胞群,即可计算出效应细胞杀伤靶细胞百分数。
AnnexiV标记法的优点
1、简单快捷,无需预标记,直接将上二试剂加入测定管即可;
2、与51Cr法相关性好(r=0.989),在早期时段更为灵敏,还可在进行分析,尤其适用于动力学分析;
3、可允许E与T长时间共育,对探讨E通过合成及分泌某些细胞因子(如TNF)而杀伤靶细胞的机理性研究特别有利;
4、可用荧光显微镜观察测定。
最新欧盟食品级测试法规food (EU) No 10 2011

TÜ V SÜ D Standard Info Bulletin
March 2011 Page 3
E. Overall migration & Specific Migration Limit 全面迁移和特殊迁移 限值
1.
2.
Overall Migration 全面迁移 - 10mg/dm² 10 毫克/平方分米 - 60mg/kg 60 毫克/千克 Specific Migration (Refer to Annex I Union List - When there is no specific migration limit or other restrictions are provided, a generic specific migration limit of 60 mg/kg shall apply) 特殊迁移(参考物质清单附录1 - 当没有提供特殊迁移限值或其他限制通常使用60mg/kg 的特殊迁移限值)
New EU Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food was published on 2011 Jan 15.This new regulation starts to effect on 2011 May 1. It repeals Commission Directive 2002/72/EC. There are several transitional provisions and are summarized in Table 1. 最新欧盟法规 10/2011 食品接触塑料及容器已于 2011 年 1 月 15 日发行,于 2011 年 5 月 1 日生效,亦废除了之前 2002/72/EC 欧盟指令,列表 1 总括了新法规及其有关证明文件之过渡转变. Table 1 列表 1
2020年最新201165EU指令RoHS Annex IV适用于医疗设备及监测控制设备的豁免条款
2011/65/EU指令附件IV中的豁免
(更新日期:2020-03-27)
说明:
附件IV中的豁免,仅适用于第8类医疗器械和第9类监控设备。
其中,若未表明明确的有效期,则最长豁免期限为7年(自第4条第3款规定的相应日期起计算)。
即对于不同的医疗设备及监控设备有效期如下:
对于附件I中第8,9类EEE(即医疗器械和监控设备类),从2014年7月22日起,至2021年7月21日止;
针对附件I中第8类设备中的体外诊断医疗器械,从2016年7月22日起,至2023年7月21日止;
针对附件I中第9类工业监控设备,从2017年7月22日起,至2024年7月21日止。
豁免的延长或更新申请应在豁免到期前至少18个月提出。
在委员会对续期申请做出决定之前,现有的豁免将一直有效。
正式决议发布后,根据欧盟委员会新指定的豁免截止日期执行。
未被提交延期或更新申请的豁免条款,在豁免期到后,必须严格执行RoHS限量要求。
2/ 16
表格说明:
橙底:已失效的豁免条款绿底:已提议的新豁免草案灰底:被取代(更新)的豁免条款蓝底:未生效的豁免条款RoHS 2.0(2011/65/EU)附件IV中的豁免内容如下:(以下清单仅供参考,文中若存在歧义的部分,请参阅英文版本。
)
3/ 16
4/ 16
5/ 16
6/ 16
7/ 16
8/ 16。
《汽车内部凸出物》问题汇总
序号项目/ECE R21条文问题1动态确定头部碰撞区Dynamic evaluation(ANNEX 8)1)实车碰撞试验(Vehicle impact tests):a)这一条欧洲是怎样执行的?在什么情况下需要进行实车碰撞试验(Vehicle impact tests)?b)另外,可否借用其他法规(ECE R94)认证试验数据而减少试验次数。
c) 在驾驶员和前排乘员位置分别安装不同的假人(比如一个位置安装第5百分位女性,另一个位置安装第95百分位男性成年假人), 进行一次试验;对调假人,再进行一次试验.这样既可以节省假人,又可以减少试验次数,有什么问题?d) 一般后排乘员头部碰撞区是否通过动态方式确定?2)滑车试验(Sled tests):a)如何进行试验,如何评价(希望提供检测过程演示图象)b) Para. 1.2.2. : ......respecting the above prescribed dummy familyand producing a direction of a forward displacement of the respectivedummies corresponding to the movement of the dummies during realfrontal impact tests according to paragraph 1.2.1. 划线内容与1.2.1.条实车碰撞试验(Vehicle impact tests)有什么联系,滑车试验(Sledtests)之前是否需要进行实车碰撞试验(Vehicle impact tests)? 对于斜体部分不理解.3)模拟碰撞试验(Simulated impact testing):这一条欧洲是怎样执行的,一般采用哪些方式?4)欧洲是怎样进行视同判定的(ANNEX 8 Paragraph 3.)?对于动态方式以及ECE R21各有哪些视同原则?5)制造商提交哪些证明文件,可以免做试验(ANNEX 8 Paragraph4.)?认证机构认可制造商提交的证明文件的原则?2车窗、活动顶盖以及隔断系统的电操作(Power-operation of windows, roofpanels and partitionsystems)1) …power-operated roof-panel systems‟ 是否仅指天窗(见Annex 9的例图),是否还包括2.8条汽车(vehicle with opening roof)的"opening roof"?/ 这一条的要求是否仅针对天窗(见Annex 9的例图),是否还针对2.8条汽车的"opening roof"?2)不明白"Power-operated partition systems"/ "a non mechanicaldevice"是一个什么结构,请给一个实例.3)希望能够拿一个活动顶盖和隔断系统的实例,具体讲解一下,要做哪几项检查,每项检查各需要满足什么要求;检测要用到哪些检测设备,如何检测。
List of Amendments Annex XVII -
REACHREACH RestrictionsREACH foresees a restriction process to regulate the manufacture, placing on the market or use of certain substances, either on their own or in mixtures or articles, within the EU territory if they pose an unacceptable risk to health or the environment. Such activities may be limited or even banned, if necessary. The restriction is designed to manage risks that are not addressed by the other REACH processes or by other Union legislation.From 1 June 2009, Annex XVII of the REACH Regulation replaced Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States, relating to restrictions on the marketing and use of certain dangerous substances and mixtures.Regulations amending Annex XVII of REACHCommission Regulation (EU) 2021/2204 of 13 December 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substancesCommission Regulation (EU) 2021/2030 of 19 November 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regardsN,N-dimethylformamideCommission Regulation (EU) 2021/1297 of 4 August 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and C9-C14 PFCA-related substancesCorrigendum to Commission Regulation (EU) 2021/1297 of 4 August 2021 amending AnnexXVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council asregards perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14PFCAs), their salts and C9-C14 PFCA-related substances (Official Journal of the EuropeanUnion L 282 of 5 August 2021)Corrigendum: In Latvian language version only, OJ L 89, page 11, 17.03.2022Commission Regulation (EU) 2021/1199 of 20 July 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards polycyclic-aromatic hydrocarbons (PAHs) in granules or mulches used as infill material in synthetic turf pitches or in loose form on playgrounds or in sport applicationsCommission Regulation (EU) 2021/57 of 25 January 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead in gunshot in or around wetlandsREACHCommission Regulation (EU) 2020/2096 of 15 December 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances, devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol and testing methods for azocolourants (Text with EEA relevance)Commission Regulation (EU) 2020/2081 of 14 December 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards substances in tattoo inks or permanent make-up (Text with EEA relevance)Commission Regulation (EU) 2020/1149 of 3 August 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards diisocyanates (Text with EEA relevance)Regulation (EU) 2019/1148 of the European Parliament and of the Council of 20 June 2019 on the marketing and use of explosives precursors, amending Regulation (EC) No 1907/2006 and repealing Regulation (EU) No 98/2013Commission Regulation (EU) 2019/957 of 11 June 2019 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) silanetriol and TDFAs (Text with EEA relevance.) Commission Regulation (EU) 2018/2005 of 17 December 2018 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regardsbis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP) (Text with EEA relevance.)Commission Regulation (EU) 2018/1513 of 10 October 2018 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards certain substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A or 1B (Text with EEA relevance)Commission Regulation (EU) 2018/675 of 2 May 2018 amending the Appendices to Annex XVII to Regulation EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards CMR substances (Text with EEA relevance)Commission Regulation (EU) 2018/589 of 18 April 2018 amending Annex XVII to Regulation EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards methanol (Text with EEA relevance)Corrigendum to Commission Regulation (EU) 2018/589 of 18 April 2018 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerningthe Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards methanolREACHCommission Regulation (EU) 2018/588 of 18 April 2018 amending Annex XVII to Regulation EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards 1-methyl-2-pyrrolidone (Text with EEA relevance)Commission Regulation (EU) 2018/35 of 10 January 2018 amending Annex XVII to Regulation EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards octamethylcyclotetrasiloxane ('D4') and decamethylcyclopentasiloxane ('D5') (Text with EEA relevance)Commission Regulation (EU) 2017/1510 of 30 August 2017 amending the Appendices to Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards CMR substances (Text with EEA relevance)Commission Regulation (EU) 2017/1000 of 13 June 2017 amending Annex XVII to Regulation EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards perfluorooctanoic acid (PFOA), its salts and PFOA-related substanceCommission Regulation (EU)2017/227 of 9 February 2017 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regardsbis(pentabromophenyl)ether –Link to Eur-LexCorrigendum to Commission Regulation (EU) 2017/227 of 9 February 2017 amending AnnexXVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Councilconcerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards bis(pentabromophenyl)etherCommission Regulation (EU) 2016/2235of 12 December 2016 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards bisphenol A –Link to Eur-LexCommission Regulation (EU) 2016/1017ED of 23 June 2016 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards inorganic ammonium saltsCommission Regulation (EU) 2016/1005ED of 22 June 2016 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards asbestos fibres (chrysotile)Commission Regulation (EU) 2016/217 ED of 16 February 2016 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards cadmium.REACHCommission Regulation (EU) 2016/26of 13 January 2016 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards nonylphenol ethoxylates.Commission Regulation (EU) 2015/1494 of 4 September 2015 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards benzene.Commission Regulation (EU) 2015/628of 22 April 2015 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Regist ration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) as regards lead and its compounds.Commission Regulation (EU) 2015/326of 2 March 2015 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards polycyclic aromatic hydrocarbons and phthalates.Commission Regulation (EU) No 474/2014 of 8 May 2014 amending Annex XVII toRegulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) as regards 1,4-dichlorobenzene.Commission Regulation (EU) No 317/2014 of 27 March 2014 amending Regulation(EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (CMR substances).Commission Regulation (EU) No 301/2014 of 25 March 2014 amending Annex XVII toRegulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards chromium VI compounds.Commission Regulation (EU) No 1272/2013of 6 December 2013 amending Annex XVII to Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards polycyclic aromatic hydrocarbons. Corrigendum: In German language version only, OJ L 109, page 49, 12.4.2014Commission Regulation (EU) No 126/2013of 13 February 2013 amending Annex XVII to Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). This Regulation corrects several entries in the Annex XVII to REACH in terms of terminology and recent update of CEN methods.Commission Regulation (EU) No 848/2012of 19 September 2012 amending Annex XVII to Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,REACHAuthorisation and Restriction of Chemicals (REACH) as regards phenylmercury compounds, prohibits the manufacture, placing on the market and use of 5 phenylmercury compounds as well as placing on the market of articles containing any of those substances at a concentration level of 0.01% or more.Commission Regulation (EU) No 847/2012of 19 September 2012 amending Annex XVII to Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards mercury, extends the scope of entry 18a to mercury measuring devices used in industrial and professional applications.Commission Regulation (EU) No 836/2012of 18 September 2012 amending Annex XVII to Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead, prohibits the placing on the market and the use of lead in jewellery articles at a concentration level of 0.05% or above.Commission Regulation (EU) No 835/2012of 18 September 2012 amending Regulation (EC) No 1907/2006 ofthe European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Cadmium), in particular the use in a list of plastic materials.Commission Regulation (EU) No 412/2012of 15 May 2012 amending Annex XVII to Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) in order to prohibit the use of dimethylfumarate (DMF) in articles or parts thereof, in concentrations greater than 0.1 mg/kg, as well as the placing on the market of articles or parts thereof containing DMF in concentrations greater than 0.1 mg/kg. It makes permanent an existing temporary prohibition adopted under Directive 2001/95/EC on general product safety.Commission Regulation (EU) No 109/2012of 9 February 2012 amending Regulation (EC) No 1907/2006 of theEuropean Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (CMR substances) amended Annex XVII of REACH in order to include a number of newly classified CMR substances in Appendices 1 to 6 so that they are aligned to the entries concerning CMR substances in Regulation (EC) No 790/2009 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.Commission Regulation (EU) No 494/2011of 20 May 2011 amending Regulation (EC) No 1907/2006 of theEuropean Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Cadmium), and, related Corrigendum OJ L 136/105of 24 May 2011. More on RestrictionsREACHCommission Regulation (EU) No 366/2011of 14 April 2011 amending Regulation (EC) No 1907/2006 of theEuropean Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Acrylamide). More on RestrictionsCommission Regulation (EU) No 207/2011adopted on 2 March 2011 deleted Entry 44 concerningpentabromodiphenyl ether and Entry 53 concerning PFOS from Annex XVII as these substances are now regulated under Regulation (EC) No 2004/850 on Persistent organic pollutants as amended by Commission Regulation (EU) No 757/2010of 24 August 2010.Commission Regulation (EU) 276/2010adopted on 31 March 2010 amended Annex XVII of REACH in order toinclude the last restrictions adopted in 2009 under Directive 76/769/EEC that is to say the modification of the restrictions concerning lamp oils and grill lighter fluids (entry 3) and organostannic compounds (entry 20) and the new restriction concerning dichloromethane (entry 59).Commission Regulation (EC) No 552/2009of 22 June 2009 amending Regulation (EC) No 1907/2006 of theEuropean Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII.。
ece_r_14.06关于安全带和儿童座椅的欧规要求
Revisions, Amendments and Supplements E/ECE/324-TRANS/505/Rev.1/Add.13 E/ECE/324-TRANS/505/Rev.1/Add.13/Amend.1 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.1, Corr.1, Corr.2 and Corr.3 -E/ECE/324-TRANS/505/Rev.1/Add.13/Amend.1 and Amend.1/Corr.1 -E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.2 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.2 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.2 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.2 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.2/Corr.1 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.2/Amend.1 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.2/Amend.1 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.2/Amend.2 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.2/Amend.3 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.2/Amend.4 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.2/Amend.4 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.3 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.3/Amend.1 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.3/Amend.2 E/ECE/324-TRANS/505/Rev.1/Add.13/Rev.3/Amend.3