一次性使用输液器标准
一次性使用输液器标准
SMIC/检测（班）医疗器械注册产品标准SMIC/检测（班）00000-2010一次性使用输液器重力输液式Infusion sets for single use, gravity fee2010-12-10发布2010-12-13实施上海医疗器械高等专科学校发布SMIC/检测（班）00000-2010前言本标准是SMIC/检测（班） 00000-2010的初定版。
本标准中华人民共和国国家标准GB 8368-2005（一次性使用输液器重力输液式）。
本标准的附录A,附录B和附录C是规范性附录，附录NA和附录NB是资料性附录。
本标准由上海医疗器械高等专科学校归口。
本标准由检测技术及应用肖婷组起草。
本标准主要起草人:肖婷、徐一君、吴维纶。
本标准主要资料检索人：吴维纶、薛国瑞。
本标准主要实验规划人：薛圣、薛子鸣、温景麟。
本标准首席发布于2010年。
SMIC/检测（班）00000-2010一次性使用输液器1 范围本标准规定了一次性使用医用输液器的要求，以保证与输液容器和静脉器具相适应。
本标准的第二个目的是为输液器所用材料的性能及质量规范提供指南，并给出了输液器组件的标记。
2 规范性引用文件下列文件中的条款通过本标准的引用而成为本标准的条款。
凡是注日期的引用文件，其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准，然而，鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。
凡是不注日期的引用文件，其最新版本适用于本标准。
GB/T8368-2005一次性使用输液器重力输液式(GB/T8368-2005,idt ISO 8536-4:2004((医用输液器具—第4部分:一次性使用输液器，重力输液式)。
GB/T1962.1-2001注射器、注射针及其他医疗器械6%锥度(鲁尔)圆锥接头第1部分:通用要求(GB/T1962.1-2001,idtISO594-1:1986)GB/T1962.2-2001注射器、注射针及其他医疗器械6%锥度(鲁尔)圆锥接头第2部分:锁定锥头(GB/T1962.2-2001,idtISO594-2:1998)GB/T6682-1992 分析实验室用水规范和试验方法(neqISO3696:1987)GB/T14233.1医用输液、输血、注射器具检验方法第1部分:化学分析方法GB/T14233.2医用输液、输血、注射器具检验方法第2部分:生物学试验方法GB15811-2001一次性使用无菌注射针(eqvISO7864:1993)YY0466 医疗器械用于医疗器械标签、标记和提供信息的符号(YY0466-2003,ISO15223: 2000,IDT)ISO14644-1:1999 洁净室和相关控制环境—第1部分:空气洁净度分级3 通用要求3.1 输液器组件的命名输液器组件的名称如图1所示，输液器进气器件如图2所示。
国家药监局关于实施《一次性使用输液器》等3项国家标准的通知
国家药监局关于实施《一次性使用输液器》等3项国家标准的通知文章属性•【制定机关】国家药品监督管理局•【公布日期】1998.12.17•【文号】国药管械[1998]187号•【施行日期】1998.12.17•【效力等级】部门规范性文件•【时效性】现行有效•【主题分类】标准化正文国家药监局关于实施《一次性使用输液器》等3项国家标准的通知（国药管械[1998]187号）各省、自治区、直辖市医药管理局或相应的医药管理部门：《一次性使用输液器》等3项国家标准业经国家质量技术监督局批准、发布，现将标准编号和名称通知如下：强制性标准：GB8368—1998一次性使用输液器(代替GB8368—93)GB8369—1998一次性使用输血器(代替GB8369—93)推荐性标准：GB/T14233.1—1998医用输液、输血、注射器具检验方法第一部分：化学分析方法(代替GB/T14233.1—93)以上标准于1999年2月1日起实施。
上述三项1998版标准中的技术指标比原标准有了更高要求，这对保证产品的安全、提高产品档次和水平、增强产品在国际上的竞争力具有重要意义。
为做好执行强制性标准GB8368—1998《一次性使用输液器》和GB8369—1998《一次性使用输血器》的工作，我局已组织全国医用输液器具标准化技术委员会进行了宣贯。
经研究，现对实施新标准，作如下规定：一、自新标准实施之日起，凡生产一次性使用输液器、输血器的企业必须按新标准要求进行生产、检验。
二、自新标准实施之日起，应按相关规定实施对产品的质量监督抽查：(一)抽查产品配套的零部件：滴斗、软管、流量调节器、穿刺器、保护套等(如滴斗外体积不小于10cm3、壁厚平均不小于0.7mm)，应符合新标准要求。
(二)生产一次性使用输液器配装所选用的空气过滤器(对空气中0.5μm以上微粒的滤过率应不小于90%)、药液过滤器(应用直径20μm±1μm胶乳粒子进行滤过率试验，滤过率应不小于80%，并保证符合新标准中规定的输液流速)应符合新标准要求。
iso8536-42010医用输液器具-重力输液式一次性使用输液器
Reference number ISO 8536-4:2010(E)© ISO 2010INTERNATIONAL STANDARD ISO 8536-4Fifth edition 2010-10-01Infusion equipment for medical use — Part 4:Infusion sets for single use, gravity feedMatériel de perfusion à usage médical —Partie 4: Appareils de perfusion non réutilisables, à alimentation par gravitéISO 8536-4:2010(E)PDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area.Adobe is a trademark of Adobe Systems Incorporated.Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.COPYRIGHT PROTECTED DOCUMENT© ISO 2010All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright officeCase postale 56 • CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@ Web Published in Switzerlandii © ISO 2010 – All rights reservedISO 8536-4:2010(E)Contents PageForeword (iv)1Scope (1)2Normative references (1)3General requirements (1)4Designation (4)4.1Infusion set (4)4.2Air-inlet device (4)5Materials (4)6Physical requirements (5)6.1Particulate contamination (5)6.2Leakage (5)6.3Tensile strength (5)6.4Closure-piercing device (5)6.5Air-inlet device (5)6.6Tubing (6)6.7Fluid filter (6)6.8Drip chamber and drip tube (6)6.9Flow regulator (6)6.10Flow rate of infusion fluid (6)6.11Injection site (6)6.12Male conical fitting (6)6.13Protective caps (6)7Chemical requirements (7)7.1Reducing (oxidizable) matter (7)7.2Metal ions (7)7.3Titration acidity or alkalinity (7)7.4Residue on evaporation (7)7.5UV absorption of extract solution (7)8Biological requirements (7)8.1General (7)8.2Sterility (7)8.3Pyrogenicity (7)8.4Haemolysis (7)8.5Toxicity (8)9Labelling (8)9.1Unit container (8)9.2Shelf or multi-unit container (8)10Packaging (9)Annex A (normative) Physical tests (10)Annex B (normative) Chemical tests (14)Annex C (normative) Biological tests (16)Bibliography (17)© ISO 2010 – All rights reserved iiiISO 8536-4:2010(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 8536-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use.This fifth edition cancels and replaces the fourth edition (ISO 8536-4:2007), of which it constitutes a minor revision. In detail, 7.1 was more clarified in alignment with B.2, and A.2.2 was changed in order to go back with the leakage test pressure to 20 kPa and to restrict the leakage test for (40 ± 1) °C.ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use:⎯Part 1: Infusion glass bottles⎯Part 2: Closures for infusion bottles⎯Part 3: Aluminium caps for infusion bottles⎯Part 4: Infusion sets for single use, gravity feed⎯Part 5: Burette infusion sets for single use, gravity feed⎯Part 6: Freeze drying closures for infusion bottles⎯Part 7: Caps made of aluminium-plastics combinations for infusion bottles⎯Part 8: Infusion equipment for use with pressure infusion apparatus⎯Part 9: Fluid lines for use with pressure infusion equipment⎯Part 10: Accessories for fluid lines for use with pressure infusion equipment⎯Part 11: Infusion filters for use with pressure infusion equipment⎯Part 12: Check valvesiv © ISO 2010 – All rights reservedINTERNATIONAL STANDARD ISO 8536-4:2010(E)Infusion equipment for medical use —Part 4:Infusion sets for single use, gravity feed1 ScopeThis part of ISO 8536 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirementsISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittingsISO 3696, Water for analytical laboratory use — Specification and test methodsISO 7864, Sterile hypodermic needles for single useISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness1) ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements2)3 General requirements3.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and air-inlet devices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated in Figure 2 should only be used for collapsible plastic containers. Infusion sets as illustrated in Figure 2 used1) Under preparation. (Revision of ISO 14644-1:1999)2) To be published. (Revision of ISO 15223-1:2007)© ISO 2010 – All rights reserved1ISO 8536-4:2010(E)with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in Figure 1, shall be used for rigid containers.3.2 The infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing device or needle.Key1 protective cap of closure-piercing device 7 fluid filter2 closure-piercing device 8 tubing3 air inlet with air filter and closure 9 flow regulator4 fluid channel 10 injection site5 drip tube 11 male conical fitting6 drip chamber 12 protective cap of male conical fittinga Closure of the air inlet is optional.b The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has anominal pore size of 15 µm.c The injection site is optional.Figure 1 — Example of a vented infusion set2 © ISO 2010 – All rights reservedISO 8536-4:2010(E)Key1 protective cap of closure-piercing device 7 tubing2 closure-piercing device 8 flow regulator3 fluid channel 9 injection site4 drip tube 10 male conical fitting5 drip chamber 11 protective cap of the male conical fitting6 fluid filtera The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has anominal pore size of 15 µm.b The injection site is optional.Figure 2 — Example of a non-vented infusion set© ISO 2010 – All rights reserved3ISO 8536-4:2010(E)Key1 protective cap 4 clamp2 closure-piercing device or needle 5 air-inlet with air filter3 tubinga Other designs are acceptable if the same safety aspects are ensured.Figure 3 — Example of an air-inlet device4 Designation4.1 Infusion setInfusion sets complying with the requirements specified in this part of ISO 8536 shall be designated by the descriptor words, followed by a reference to this part of ISO 8536, followed by the letters IS, followed by the letter G:Infusion set ISO 8536-4 - IS - G4.2 Air-inlet deviceAir-inlet devices complying with the requirements specified in this part of ISO 8536 shall be designated by the descriptor words, followed by a reference to this part of ISO 8536, followed by the letters IS, followed by the letters AD:Air-inlet device ISO 8536-4 - IS - AD5 MaterialsThe materials from which the infusion set and its components are manufactured (as described in Clause 3) shall comply with the requirements specified in Clause 6. Where components of the infusion set come into contact with solutions, the materials shall also comply with the requirements specified in Clauses 7 and 8.4 © ISO 2010 – All rights reservedISO 8536-4:2010(E)6 Physical requirements6.1 Particulate contaminationThe infusion sets shall be manufactured under conditions that minimize particulate contamination. All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in A.1, the number of particles shall not exceed the contamination index limit.6.2 LeakageThe infusion set, when tested in accordance with A.2, shall show no signs of air leakage.6.3 Tensile strengthWhen tested as specified in A.3, the infusion set, excluding protective caps, shall withstand a static tensile force of not less than 15 N for 15 s.6.4 Closure-piercing deviceThe dimensions of the closure-piercing device shall conform to the dimensions shown in Figure 4.NOTE The dimension of 15 mm in Figure 4 is a reference measurement. The cross-section of the piercing device at this site is a circle.The closure-piercing device shall be capable of piercing and penetrating the closure of a fluid container without pre-piercing. No coring should occur during this procedure.Dimensions in millimetresFigure 4 — Dimensions of the closure-piercing device6.5 Air-inlet deviceThe air-inlet device shall conform to 3.2 and 8.2.The air-inlet device shall be provided with an air filter to prevent the ingress of microorganisms into the container into which the device is to be inserted.The air-inlet device shall be separate from, or integral with, the closure-piercing device.When the air-inlet device is inserted into a rigid infusion container, the air admitted into the container shall not become entrained in the liquid outflow.The air filter shall be fitted such that all air entering the rigid container passes through it, and such that the flow of fluid is not reduced by more than 20 % of that from a freely ventilated container when tested in accordance with A.4.© ISO 2010 – All rights reserved5ISO 8536-4:2010(E)6.6 TubingThe tubing, made of flexible material, shall be transparent or sufficiently translucent that the interface of air and water during the passage of air bubbles can be observed with normal or corrected vision.The tubing from the distal end to the drip chamber shall be not less than 1 500 mm in length, including the injection site, when provided, and the male conical fitting.6.7 Fluid filterThe infusion set shall be provided with a fluid filter.When tested in accordance with A.5, the retention of latex particles on the filter shall be not less than 80 %. 6.8 Drip chamber and drip tubeThe drip chamber shall permit continuous observation of the fall of drops. The liquid shall enter the drip chamber through a tube that projects into the chamber. There shall be a distance of not less than 40 mm between the end of the drip tube and the outlet of the chamber, or a distance of not less than 20 mm between the drip tube and the fluid filter. The wall of the drip chamber shall not be closer than 5 mm to the end of the drip tube. The drip tube shall be such that 20 drops of distilled water or 60 drops of distilled water at (23 ± 2) °C at a flow rate of (50 ± 10) drops/min deliver a volume of (1 ± 0,1) ml or a mass of (1 ± 0,1) g. The drip chamber should permit and facilitate the priming procedure.6.9 Flow regulatorThe flow regulator shall adjust the flow of the infusion solution between zero and the maximum. The flow regulator should be capable of continuous use throughout an infusion without the tubing being damaged. There should be no deleterious reaction between the flow regulator and the tubing when they are stored in such a way that there is contact.6.10 Flow rate of infusion fluidThe infusion set shall deliver not less than 1 000 ml of a sodium chloride solution [mass concentration ρ(NaCl) = 9 g/l] in 10 min under a static head of 1 m.6.11 Injection siteWhen provided, the self-sealing injection site shall reseal when tested in accordance with A.6, and there shall be no leakage of more than one falling drop of water. The injection site should be located near the male conical fitting.6.12 Male conical fittingThe distal end of the tubing shall terminate in a male conical fitting in accordance with ISO 594-1 or ISO 594-2. Luer lock fittings in accordance with ISO 594-2 should preferably be used.6.13 Protective capsThe protective caps at the end of the infusion set shall maintain the sterility of the closure-piercing device, the male conical fitting and the interior of the infusion set. Protective caps should be secure but easily removable.6 © ISO 2010 – All rights reserved7 Chemical requirements7.1 Reducing (oxidizable) matterWhen tested in accordance with B.2, the difference of volume of Na2S2O3 solution [c(Na2S2O3) = 0,005 mol/l] for the extract solution S1 and of volume of Na2S2O3 solution for blank solution S0 shall not exceed 2,0 ml. 7.2 Metal ionsThe extract shall not contain in total more than 1 µg/ml of barium, chromium, copper, lead and tin, and not more than 0,1 µg/ml of cadmium, when determined by atomic absorption spectroscopy (AAS) or an equivalent method.When tested in accordance with B.3, the intensity of the colour produced in the test solution shall not exceed that of the standard matching solution with a mass concentration ρ(Pb2+) = 1 µg/ml.7.3 Titration acidity or alkalinityWhen tested in accordance with B.4, not more than 1 ml of either standard volumetric solution shall be required for the indicator to change to the colour grey.7.4 Residue on evaporationWhen tested in accordance with B.5, the total amount of dry residue shall not exceed 5 mg.7.5 UV absorption of extract solutionWhen tested in accordance with B.6, the extract solution S1 shall not show absorption greater than 0,1.8 Biological requirements8.1 GeneralThe infusion set shall be assessed for biological compatibility according to the guidelines given in C.2.8.2 SterilityThe infusion set or the air-inlet device, or both, in its unit container shall have been subjected to a validated sterilization process (see ISO 11135, ISO 11137 and ISO 17665).8.3 PyrogenicityThe infusion set and/or the air-inlet device shall be assessed for freedom from pyrogens by using a suitable test, and the results shall indicate that the infusion set is free from pyrogens. Guidance on testing for pyrogenicity is given in C.1.8.4 HaemolysisThe infusion set shall be assessed for freedom from haemolytic constituents and the result shall indicate that the infusion set is free from haemolytic reactions. Guidance on testing for haemolytic constituents is given in ISO 10993-4.© ISO 2010 – All rights reserved78.5 ToxicityMaterials shall be assessed for toxicity by carrying out suitable tests, and the results of the tests shall indicate freedom from toxicity. Guidance on testing for toxicity is given in ISO 10993-1.9 Labelling9.1 Unit containerThe unit container shall be labelled with at least the following information:a) a textual description of the contents, including the words “Gravity feed only”;b) indication that the infusion set is sterile, using the graphical symbol as given in ISO 15223-1;c) indication that the infusion set is free from pyrogens, or that the infusion set is free from bacterialendotoxins;d) indication that the infusion set is for single use only, or equivalent wording, or using the graphical symbolin accordance with ISO 15223-1;e) instructions for use, including warnings, e.g. about detached protective caps;NOTE Instructions for use can also take the form of an insert.f) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol in accordance withISO 15223-1;g) year and month of expiry, accompanied by appropriate wording or the graphical symbol in accordancewith ISO 15223-1;h) the manufacturer's or supplier's name and address, or both;i) a statement that 20 drops of distilled water or 60 drops of distilled water delivered by the drip tube areequivalent to a volume of (1 ± 0,1) ml or a mass of (1 ± 0,1) g;j) the nominal dimensions of the intravenous needle, if included.9.2 Shelf or multi-unit containerThe shelf or multi-unit container, when used, shall be labelled with at least the following information:a) a textual description of the contents, including the words “Gravity feed only”;b) the number of infusion sets;c) indication that the infusion sets are sterile, using the graphical symbol as given in ISO 15223-1;d) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol in accordance withISO 15223-1;e) year and month of expiry, accompanied by appropriate wording or the graphical symbol in accordancewith ISO 15223-1;f) the manufacturer's and/or supplier's name and address;g) the recommended storage conditions, if any.10 Packaging10.1 The infusion set and/or the air-inlet device shall be individually packed so that they remain sterile during storage. The unit container shall be sealed in a tamper-evident manner.10.2 The infusion sets and/or the air-inlet devices shall be packed and sterilized in such a way that there are no flattened portions or kinks when they are ready for use.© ISO 2010 – All rights reserved9Annex A(normative)Physical testsA.1 Test for particulate contaminationA.1.1 PrincipleThe particles are rinsed from the inner fluid pathway surfaces of the infusion set, collected on a membrane filter and microscopically counted.A.1.2 Reagents and materialsA.1.2.1 Distilled water,filtered through a membrane of pore size 0,2 µm.A.1.2.2 Non-powdered gloves.A.1.2.3 Vacuum filter, single membrane filter of pore size 0,45 µm.A.1.3 ProcedureThe filter unit, filter and all other equipment shall be thoroughly cleaned before the test using distilled water (A.1.2.1).Flush through 10 ready-to-use infusion appliances, under laminar flow conditions (clean-air work station class N5 in accordance with ISO 14644-1), with 500 ml of distilled water (A.1.2.1). The total volume is subsequently vacuum filtered (A.1.2.3). Place the particles on the membrane screen filter under a microscope at ×50 magnification using diagonally incident illumination, and measure and count in accordance with the size categories given in Table A.1.A.1.4 Determination of resultsA.1.4.1 GeneralAn appropriate number of single infusion sets (minimum of 10) are tested. The number of particles per10 infusion sets tested in each of the three size categories is the assay result.A.1.4.2 Particle countsThe values obtained from a blank control sample shall be recorded in a test report and taken into account when calculating the contamination index limit.The blank control sample is the number and size of particles obtained from 10 equivalent 500 ml water samples classified in accordance with the three size categories set out in Table A.1, using the same test equipment but not passed through the appliances under test.The number of particles in the blank, N b, shall not exceed the value of 9. Otherwise, the test apparatus shall be disassembled, re-cleaned, and the background test performed again. Values of the blank determination shall be noted in the test report.Table A.1 — Evaluation of contamination by particlesSize categoryParticle parameters1 2 3 Particle size in µm 25 to 50 51 to 100 over 100Number of particles in 10 infusion appliances n a1n a2n a3Number of particles in the blank control sample n b1n b2n b3Evaluation coefficient 0,1 0,2 5The contamination index limit is calculated as follows.For each of the three size categories, multiply the number of particles in 10 infusion appliances by the evaluation coefficients, and add the results in order to obtain the number of particles in the infusion appliances(test pieces), N a. Then, for each of the size categories, multiply the number of particles in the blank control sample by the evaluation coefficients and add the results to obtain the number of particles in the blank sample,N b.Subtract N b from N a to obtain the contamination index limit.Number of particles in the infusion appliances (test pieces):N a=n a1× 0,1 +n a2× 0,2 +n a3× 5Number of particles in the blank sample:N b=n b1× 0,1 +n b2× 0,2 +n b3× 5Contamination index limit:N=N a−N b u 90A.2 Test for leakageA.2.1 At the beginning of the test, condition the whole system at the test temperature.A.2.2 Immerse the infusion set, with one end blocked, in water at (40 ±1) °C and apply an internal air pressure of 20 kPa for 15 s. Examine the infusion set for air leakage.A.2.3 Fill the infusion set with degassed, distilled water, connect it with its openings sealed to a vacuumdevice and subject it to an internal excess pressure of −20 kPa at (40 ± 1) °C for 15 s. Atmospheric pressureshall be the reference pressure. Excess pressure, in accordance with ISO 80000-4, can assume positive or negative values. Ascertain whether air enters the infusion set.A.3 Test for tensile strengthExpose the infusion set to be tested to a static tensile force of 15 N applied along the longitudinal axis for 15 s. Inspect whether the infusion set withstands the test force applied.© ISO 2010 – All rights reserved11A.4 Determination of flow rate when using an air-inlet deviceA.4.1 Fill an infusion container with distilled water at (23 ± 2) °C and insert its closure. Insert the air-inlet device through the closure into the container and then insert the infusion set with the flow regulator set, such that no liquid flows. Arrange the container to give the equivalent of a pressure of 1 m head of water throughout the test. Open the flow regulator of the infusion set to maximum and measure the rate of flow of water from the set. Repeat the procedure with the filter removed from the air-inlet device.A.4.2 For air-inlet devices integral with the closure-piercing device of the infusion set, follow the procedure given in A.4.1 but omit the insertion of the separate air-inlet device.A.5 Test for efficiency of the fluid filterA.5.1 Preparation of the test fluidAs a test liquid, use an aqueous suspension of latex particles with a diameter of (20 ± 1) µm and a concentration of approximately 1 000 particles per 100 ml.A.5.2 ProcedureAssemble the fluid filter and position it so that it is equivalent to that of actual use in a suitable test apparatus in accordance with Figure A.1. Cut the tubing of the infusion set approximately 100 mm below the fluid filter. Flush the fluid filter with 5 ml of the test fluid from the storage bottle and discard the filtrate. Pass 100 ml of the test fluid through the fluid filter and collect the effluent under vacuum after passing it through a black gridded membrane filter with a pore size of 5 µm to 8 µm and 47 mm diameter. Mount the membrane with any retained latex particles on a suitable microscope slide or holder and count the latex particles in a minimum of 50 % of the grid squares under a magnification of ×50 to ×100. Disregard any particles which are obviously non-latex.Carry out the test in duplicate.Repeat the test if the required limit value of 80 % retention rate is not met.All procedures involved in this test should be conducted in a clean environment, if possible under laminar flow.A.5.3 Expression of results The retention rate of the filter, expressed as a percentage, is given by101100n n ⎛⎞−×⎜⎟⎝⎠ (A.1)wheren 1 is the number of particles retained on the filter;n 0 is the number of particles in the test fluid used.Dimensions in millimetresKey1 storage bottle 5 piercing device2 transfer tube 6 fluid filter3 flow regulator 7 membrane filter4 connecting pieceFigure A.1 — Apparatus for testing the efficiency of the fluid filterA.6 Test of the injection sitePlace the injection site in a horizontal, stress-free position. Fill the infusion set with water in such a manner that no air bubbles are trapped and apply a pressure of 50 kPa above the atmospheric air pressure. Perforate the injection site at the foreseen area using a hypodermic needle with an outside diameter of 0,8 mm and which conforms to ISO 7864. Keep the needle in position for 15 s. Remove the needle and immediately dry the perforated site. Over a period of 1 min, observe whether there is any leakage from the injection site. In the case of an alternative injection site design, the test should be performed by injection into the site in accordance with the instructions provided by the manufacturer.© ISO 2010 – All rights reserved13。
输液器使用说明书
输液器使用说明书
一、产品名称：一次性使用输液器
二、产品结构：由瓶塞穿刺器、滴管、流速调节器、空气过滤器、静脉导管和保护帽组成。
三、适用范围：用于静脉输液或输血。
四、使用方法：
1.将输液瓶挂在输液架上，打开瓶盖，插入瓶塞穿刺器并旋转锁定。
2.将静脉导管从滴管上拆下，并检查是否完好无损。
3.打开滴管，将滴管与静脉导管连接，并拧紧连接器。
4.根据医嘱调整滴速，一般成人每分钟约20-60滴。
5.开始输液后，需经常观察滴速是否稳定，有无漏液现象。
6.输液结束后，将滴管及静脉导管拔下，并关闭瓶盖。
将使用过的输液器放入医疗垃圾袋中。
五、注意事项：
1.使用前请检查包装是否完好无损，如发现包装破损请勿使用。
2.本产品为一次性使用产品，请勿重复使用。
3.使用过程中如出现不适症状，应立即停止使用并就医。
4.请在医生指导下使用本产品。
输液器标准GB8368-2005宣贯
附录 B
B.6 吸光度试验
化学试验
8 生物要求（1）
8.1 总则 输液器应按第C.2章给出的指南进行生物相容性评价。 8.2 无菌 单元容器内的输液器和 /或进气器件应经过一个确认过的灭菌 过程(见参考文献 )。
注：GB/T 14233.2规定了无菌试验方法，但该方法不能用于证实灭菌 批的灭菌效果(另见NA.8)。
9 标志
9.2 搁板包装或多单元包装 搁板包装或多单元包装(如使用)上应至少有下列信 息: a) 文字说明内装物, 包括“只能重力输液”字样; b) 输液器数量; c) 使用YY 0466给出的图形符号, 标明输液器无菌; d) 批号, 以“批”字或“LOT”打头，或使用符合 YY 0466给出的图形符号; e) 失效年月，附以适当文字，或符合YY 0466给出 的图形符号; f) 制造商和/或经销商名称和地址; g) 推荐的贮存条件(如果有)。
7 化学要求
化学性能的改动情况
7.3 酸碱度滴定 按第 B.4 条试验时 , 使指示剂颜色变灰色所需的任 何一种标准溶液应不超过1mL。 7.5 浸提液紫外吸光度 按第B.6条试验时 , 浸提液 S1的吸光度应不大于 0.1。 7.6 环氧乙烷残留量 按 GB/T 14233.1 进行试验时，每套输液器的环氧 乙烷残留量应不大于0.5mg(另见NA.8.2) 。 （国际标准中没有此条）
附录NA 实施指南
NA.6 流量调节器 流量调节器的调节行程宜足够大，滚轮式流量调节器 的调节行程宜不小于 30mm ，否则可认定为不符合 6.9 的 要求。
6.9 流量调节器应能调节液流从零至最大。
NA.7 保护套 为了便于灭菌过程，保护套头端可以设计成开口的， 但保护套的长度宜比被保护对象长，且不会自然脱落， 否则可认定为不符合6.13的要求。
输液器标准
医疗器械注册产品标准YZB/国—2012代替YZB/国—2006一次性使用输液器带针2012-01-05发布2012-01-26实施上海XX医疗器械有限公司发布前言本标准中的带针是指一次性使用输液器带静脉输液针。
本标准采用GB8368—2005《一次性使用输液器重力输液式》和GB 18671-2009《一次性使用静脉输液针》要求编写。
GB 8368—2005中的附录A、附录B、附录C、附录NA、附录NB和GB18671-2009中所有附录A、附录B、附录C、附录D都适用于本标准。
本标准提出了出厂检验要求。
本标准由上海XX医疗器械有限公司提出。
本标准由上海XX医疗器械有限公司生产技术部归口。
本标准由上海XX医疗器械有限公司生产技术部起草。
本标准主要起草人：XX本标准所替代标准的历次版本发布情况为：————YZB/国XXXX—2006一次性使用输液器带针1范围本标准规定了一次性使用输液器带针的要求。
2规范性引用标准下列标准所包含的条文，通过在本标准引用而构成为本标准的条文。
本标准出版时，所示标准均为有效。
所有标准都会被修订，使用本标准的各方应探讨使用下列标准最新版本的可能性。
GB/T 1962.1-2001 注射器、注射针及其他医疗器械6%锥度（鲁尔）圆锥接头第1部分：通用要求（GB/T 1962.1-2001,idt ISO 594-2:1998）GB/T 1962.2 -2001 注射器、注射针及其他医疗器械6%锥度（鲁尔）圆锥接头第2部分：锁定锥头（GB/T 1962.2-2001,idt ISO 594-2:1998）GB/T 14233.1-2008 医用输液、输血、注射器具检验方法第1部分：化学分析法GB/T 14233.2-2005 医用输液、输血、注射器具检验方法第2部分：生物学试验方法GB18671-2009 一次性使用静脉输液针YY 0466-2003 医疗器械用于医疗器械标签、标记和提供信息的符号（YY 0466-2003，ISO 15233:2000,IDT）GB/T 2828.1-2003 逐步检查计数抽样程序及抽样表（适用于连续批得检查）GB 8368-2005 一次性使用输液器重力输液式GB/T 14437-1997 产品质量计数一次监督抽样检验程序（适用于总体量较大的情形）GB/T 16886.1-2001 医疗器械生物学评价第1部分：评价与试验GB 18457-2001 制造医疗器械用不锈钢针管YY/T 0313-1998 医用高分子产品包装、标志、运输和贮存3通用要求和结构3.1输液器组件的名称如图1至图14所示。
一次性使用输液器演示文稿
一次性使用输液器演示文稿
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目录 6 物理要求
6.2泄漏 6.3拉伸强度 6.4瓶塞穿刺器 6.5进气器件 6.6管路
9 标志 10包装
一次性使用输液器演示文稿
一次性使用输液器 --- 物理要求
6.8滴斗与滴管 6.9流量调整器 6.11注射件 6.12 外圆锥接头 6.13保护套
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6.5.2 进气器件与输液器瓶塞穿刺器为 一次性使用输液器 --- 物理要求
一体或分离均为合格。
6.5.3 当进气器件插入硬质容器时，进
入容器空气应不进入到流出液中。
6.5.3.1 试验方法 将被测输液器穿刺器刺入一硬 质容器(内装液体)，放开流量调 整器至最大，将进气器件插入 同一硬质容器中，检验进入容 器空气有没有进入流出液。
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一次性使用输液器 --- 物理要求
物理性能存在主要问题： 1、管路长度 2、注射件 3、液滴重量 4、外圆锥接头
一次性使用输液器演示文稿
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一次性使用输液器 --- 物理要求
谢谢！
一次性使用输液器演示文稿
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精度为0.01g天平、50mL烧杯。
b) 试验方法
在室温23℃±2℃，调整液滴流速为50滴/min±
10滴/min，用已知重量烧杯在输液器末端接取滴管内滴 下20滴蒸馏水。用精度为0.01g天平称重。
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一次性使用输液器 --- 物理要求
c) 注意事项 (1)读液滴数量时，应先将输液器管腔内空气排 尽， (2)从滴管处读取而不是在圆锥接头处读数。 (3)假如试验结果在边缘处，应连续取60滴蒸馏 水，称重，所得数据除以3作为检验结果。
输液器标准
医疗器械注册产品标准YZB/国—2012代替YZB/国—2006一次性使用输液器带针2012-01-05发布2012-01-26实施上海XX医疗器械有限公司发布前言本标准中的带针是指一次性使用输液器带静脉输液针。
本标准采用GB8368—2005《一次性使用输液器重力输液式》和GB 18671-2009《一次性使用静脉输液针》要求编写。
GB 8368—2005中的附录A、附录B、附录C、附录NA、附录NB和GB18671-2009中所有附录A、附录B、附录C、附录D都适用于本标准。
本标准提出了出厂检验要求。
本标准由上海XX医疗器械有限公司提出。
本标准由上海XX医疗器械有限公司生产技术部归口。
本标准由上海XX医疗器械有限公司生产技术部起草。
本标准主要起草人：XX本标准所替代标准的历次版本发布情况为：————YZB/国XXXX—2006一次性使用输液器带针1范围本标准规定了一次性使用输液器带针的要求。
2规范性引用标准下列标准所包含的条文，通过在本标准引用而构成为本标准的条文。
本标准出版时，所示标准均为有效。
所有标准都会被修订，使用本标准的各方应探讨使用下列标准最新版本的可能性。
GB/T 1962.1-2001 注射器、注射针及其他医疗器械6%锥度（鲁尔）圆锥接头第1部分：通用要求（GB/T 1962.1-2001,idt ISO 594-2:1998）GB/T 1962.2 -2001 注射器、注射针及其他医疗器械6%锥度（鲁尔）圆锥接头第2部分：锁定锥头（GB/T 1962.2-2001,idt ISO 594-2:1998）GB/T 14233.1-2008 医用输液、输血、注射器具检验方法第1部分：化学分析法GB/T 14233.2-2005 医用输液、输血、注射器具检验方法第2部分：生物学试验方法GB18671-2009 一次性使用静脉输液针YY 0466-2003 医疗器械用于医疗器械标签、标记和提供信息的符号（YY 0466-2003，ISO 15233:2000,IDT）GB/T 2828.1-2003 逐步检查计数抽样程序及抽样表（适用于连续批得检查）GB 8368-2005 一次性使用输液器重力输液式GB/T 14437-1997 产品质量计数一次监督抽样检验程序（适用于总体量较大的情形）GB/T 16886.1-2001 医疗器械生物学评价第1部分：评价与试验GB 18457-2001 制造医疗器械用不锈钢针管YY/T 0313-1998 医用高分子产品包装、标志、运输和贮存3通用要求和结构3.1输液器组件的名称如图1至图14所示。
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SMIC/检测（班）医疗器械注册产品标准SMIC/检测（班）00000-2010一次性使用输液器重力输液式Infusion sets for single use, gravity fee2010-12-10发布2010-12-13实施上海医疗器械高等专科学校发布SMIC/检测（班）00000-2010前言本标准是SMIC/检测（班） 00000-2010的初定版。
本标准中华人民共和国国家标准GB 8368-2005（一次性使用输液器重力输液式）。
本标准的附录A,附录B和附录C是规范性附录，附录NA和附录NB是资料性附录。
本标准由上海医疗器械高等专科学校归口。
本标准由检测技术及应用肖婷组起草。
本标准主要起草人:肖婷、徐一君、吴维纶。
本标准主要资料检索人：吴维纶、薛国瑞。
本标准主要实验规划人：薛圣、薛子鸣、温景麟。
本标准首席发布于2010年。
SMIC/检测（班）00000-2010一次性使用输液器1 范围本标准规定了一次性使用医用输液器的要求，以保证与输液容器和静脉器具相适应。
本标准的第二个目的是为输液器所用材料的性能及质量规范提供指南，并给出了输液器组件的标记。
2 规范性引用文件下列文件中的条款通过本标准的引用而成为本标准的条款。
凡是注日期的引用文件，其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准，然而，鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。
凡是不注日期的引用文件，其最新版本适用于本标准。
GB/T8368-2005一次性使用输液器重力输液式(GB/T8368-2005,idt ISO 8536-4:2004((医用输液器具—第4部分:一次性使用输液器，重力输液式)。
GB/T1962.1-2001注射器、注射针及其他医疗器械6%锥度(鲁尔)圆锥接头第1部分:通用要求(GB/T1962.1-2001,idtISO594-1:1986)GB/T1962.2-2001注射器、注射针及其他医疗器械6%锥度(鲁尔)圆锥接头第2部分:锁定锥头(GB/T1962.2-2001,idtISO594-2:1998)GB/T6682-1992 分析实验室用水规范和试验方法(neqISO3696:1987)GB/T14233.1医用输液、输血、注射器具检验方法第1部分:化学分析方法GB/T14233.2医用输液、输血、注射器具检验方法第2部分:生物学试验方法GB15811-2001一次性使用无菌注射针(eqvISO7864:1993)YY0466 医疗器械用于医疗器械标签、标记和提供信息的符号(YY0466-2003,ISO15223: 2000,IDT)ISO14644-1:1999 洁净室和相关控制环境—第1部分:空气洁净度分级3 通用要求3.1 输液器组件的命名输液器组件的名称如图1所示，输液器进气器件如图2所示。
注:图1给出了输液器示例，图2示出了分离式进气器件，图1和图2不作为本标准对一次性使用输液器的要求。
3.2 无菌的保持输液器应有保护套，保持输液器内部在使用前无菌。
进气器件的瓶塞穿刺器或针应有保护套。
3.3 标记3.3.1 输液器符合本标准要求的输液器应以描述文字加本标准编号、字母IS，再加字母G标记:输液器SMIC00000 - IS-G3.3.2 进气器件符合本标准要求的进气器件应以描述文字加本标准编号，最后加字母AD:进气器件SMIC00000一A DSMIC/检测（班）00000-20101—瓶塞穿刺器保护套2—瓶塞穿刺器3—带空气过滤器和塞子的进气口4—液体通道5—滴管6—漏斗7—药液过滤器8—软管9—流量调节器10—注射件11—外圆锥接头12—外圆锥接头保护套a 进气器件可以不带塞子b 药液过滤器可以在其他位置，最好位于病人端药液过滤器的孔径大小一般为15 1-c可以不带注射件图1 输液器示例SMIC/检测（班）00000-20101—保护套2—瓶塞穿刺器或穿刺针3—管路4—夹子5—带有空气过滤器的进气器件“如能保证同样安全，也可不带夹子或采用其他设计。
图2 典型进气器件示例4材料制造第3章给出的输液器及其进气器件的材料应符合第5章规定的要求。
输液器与输液容器接触的组件，还应符合第6章和第7章规定的要求。
5 物理要求5.1 微粒污染应在最小微粒污染条件下制造输液器。
液体通路表面应光滑并洁净，测试输液器内的微粒，是通过冲洗输液器内腔道表面，用适当的方法对微粒进行计数。
按第A.1 章试验时，应不超过污染指数。
5.2 泄漏按第A .2章试验时，应无气体泄漏现象.5.3 连接强度按第A .3章试验时，输液器液体通道各组件间的连接，不包括保护套，应能承受不小于15N 的静拉力，持续15 s.5.4 瓶塞穿刺器瓶塞穿刺器的尺寸应符合图3所示。
SMIC/检测（班）00000-2010单位为毫米图3 瓶塞穿刺器尺寸注:图3中的15mm尺寸为测量基准，穿刺器该处横截面为圆形。
瓶塞穿刺器应能刺透未穿刺过的液体容器的瓶塞，且不宜产生落屑。
5.5 进气器件进气器件应符合3.2 和8.2的要求。
进气器件应有一个空气过滤器，以防止微生物进人它所插人的容器。
进气器件可以与瓶塞穿刺器连为一体，也可以与之分离。
当进气器件插人硬质输液容器时，进人容器的空气应不进人到流出液中。
空气过滤器的安装应使所有进人硬质容器的空气都通过它。
按第A.4章试验时，相对于从自由进气的容器中流出液体的流量应不降低20%.5.6 管路5.6.1 由塑性材料制成的管路应透明或足够透明，当有气泡通过时可以用正常或矫正视力观察到水和空气的分界面。
5.6.2末端至滴斗的管路包(括注射件(如果有)和外圆锥接头〕长度应不小于1500mm,注 :在输液器的总长度不小于1600mm的前提下,末端至滴斗的管路(包括注射件(如果有)和外圆锥接头)长度允许小于1500mm,但应不小于1250mm.5.7 药液过滤器输液器应有一药液过滤器，药液过滤器对乳胶粒子的滤除率应不小于80%。
5.8 滴斗与滴管滴斗应可以连续观察液滴。
液体应经过一插人滴斗的滴管进人滴斗。
滴管的端部至滴斗出口的距离应不小于40mm，或滴管和药液过滤器间的距离应不小于20mm,滴斗壁与滴管终端的距离不得近于5mm。
在(23士2)0C,流速为(50士10)滴/min的条件下，滴管滴出20滴蒸馏水应为(1士0.1)mL[(1士0.1)g]。
滴斗应有助于液体充注过程。
5.9 流量调节器流量调节器应能调节液流从零至最大。
流量调节器宜能在一次输液中持续使用而不损伤管路。
流量调节器和管路接触在一起贮存时宜不产生有害反应。
5.10 输液流速对于滴管为20滴/mL的输液器，输液器在1m静压头下，10min内输出氯化钠溶液[质量浓度ρ（NaCl）=9g/L]应不少于1000mL；对于滴管为60滴/mL的输液器，输液器在1m静压头下，SMIC/检测（班）00000-2010 40min内输出氯化钠溶液[质量浓度ρ（NaCl）=9g/L]应不少于1000mL。
5.11 注射件如有自密封性注射件时，按第A.5章试验时，水的泄漏量应不超过一滴。
注射件宜位于外圆锥接头附近。
5.12 外圆锥接头管路的末端应有一符合GB/T1962.1或GB/T1962.2的外圆锥接头。
宜使用符合GB/T1962.2的(鲁尔)锁定锥头。
5.13 保护套输液器终端的保护套应保持瓶塞穿刺器、外圆锥接头和输液器无菌。
保护套宜牢靠，但易于拆除。
6 化学要求6.1 环氧乙烷残留量按GB/T14233.1进行试验时，每套输血器的环氧乙烷残留量应不大于0.5mg(另见9).7 生物要求7.1 无菌单包装内的输液器和(或)进气器件应经过一个确认过的灭菌过程使产品无菌。
8 标志8.1 单包装单包装上应至少标有下列信息:1)文字说明内装物，包括“只能重力输液”字样2)使用YY0466中的图形符号，标明输液器无菌3)输液器无热原和无细菌内毒素4)输液器和/或进气器件仅供一次性使用，或同等说明，或使用符合YY0466中的图形符号5)使用说明，包括警示，如关于保护套脱落6)批号，以“批”字或“LOT'，开头，或使用符合YY0466中的图形符号7)失效年月，附以适当文字，或使用符合YY0466中的图形符号8)制造商和/或供应商名称和地址9)滴管滴出20滴或60滴蒸馏水等于(1士0.1)mL[即(1士0.1)g]的说明10)如配静脉针，应著名标称尺寸8.2 搁板或多单元包装搁板包装或多单元包装(如使用)上应至少有下列信息:1)文字说明内装物，包括“只能中立输液”字样2)输液器数量3)使用YY0466中的图形符号，标明输液器无菌4)批号，以“批”字或“LOT”开头，或使用符合YY0466中的图形符号5)失效年月，附以适当文字，或符合YY0466中的图形符号6)制造商和/或供应商的名称和地址7)推荐的贮存条件(如果有)9 包装SMIC/检测（班）00000-2010 9.1输液器和/或进气器件应单件包装，以使其在贮存期内保持无菌。
单包装打开后应留有打开过的迹象。
9.2 输液器和/或进气器件的包装和灭菌应使其在备用时无扁瘪或打折。
附录物理试验A. 1 微粒污染试验，1)A.1.1 原理通过冲洗输液器内腔液体通道表面，收集滤膜上的微粒，并用微粒检测仪进行计数。
A.1.2 试剂和材料A.1.2.1 蒸馏水，用孔径0.2l um的膜过滤。
A.1.2.2 无粉手套。
A.1.2.3 真空滤膜，孔径0. 45um,A.1.3 步骤试验前应用蒸馏水(A.1.2.1)充分清洗过滤装置、滤膜和其他器具。
在层流条件下(符合ISO 14644-1;1999中的N5级)2的净化工作台)，取10支供用状态的输液器，各用500mL蒸馏水(A.1.2.1)冲洗内腔，然后使各洗脱液通过一个真空滤膜(A.1.2.3)，用装有500mL 的NaCl注射液洗瓶冲洗滤膜，样品杯收集的冲洗液，放到仪器样品台上对其进行测量，并按表A. 1所给尺寸分类进行计数。
A.2 泄漏试验A.2.1 试验开始前，在试验温度下状态调节整个系统。
A.2.2 将输液器一端堵住，浸人20'C -30℃水中，内部施加高于大气压强50k Pa的气压15s 。
检验输液器空气泄漏。
A.3 拉伸强度试验使供试输液器经受15 N的静态轴向拉力15 s，检验输液器是否能承受该拉力。
A.4 使用进气器件时流速的测量A.4.1 向一只输液容器内充人(23士2)℃的蒸馏水，盖上瓶塞。
进气器件通过瓶塞插入该容器，然后插人输液器。
关闭流量调节器，调节容器高度，使其在整个试验过程中形成1 m水压头，调节流量调节器至最大，测量输液器中水的流速。
从进气器件上取下过滤器，重复此步骤。