ISO 11608-2 2000中英对照版

Pen-injectors for medical use-Part 2:Needles Requirements and test methods1 Scope1 范围This part of ISO 11608 specifies requirements and test methods for single-use, double-ended, sterile needles for pen-injectors which fulfill the specifications of ISO 11608-1本部分ISO11608 指定了符合ISO11608-1所述一次性使用，双头，无菌笔式注射器用针的要求和测试方法。It is not applicable to needles for dental use.不适用于牙科用针。2 Normative references2 引用标准The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 11608. For dated references, subsequent amendments to, or revisions of ,any of these publications do not apply. However, parties to agreements based on this part of ISO 11608 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.以下标准文件包含的条款，引用在本文中，组成ISO11608的本部分。注明日期的版本， 其随后的修改或修订版，均不适用。然而，鼓励基于ISO11608的这一部分达成协议的各方调查采用以下规范性文件的最新版本的可能性。凡是不注日期的引用文件规范性文件，其最新版本适用于本标准。国际标准化组织（ISO）和国际电工委员会（IEC）的成员保持登记的当前有效的国际标准。ISO 6009:1992, Hypodermic needles for single use- Colour coding for identification.ISO6009:1992，一次性使用皮下注射针的色标识别ISO 7864:1993, Sterile hypodermic needles for single use.ISO 7864:1993,一次性使用无菌皮下注射针ISO 9626:1991,Stainless steel needle tubing for manufacture of medical devices.ISO9626:1991，制造医疗器械用不锈钢针管。ISO 11608-1:2000, pen-injectors for medical use Part 1: Pen-injectors-Requirements and test methods.ISO11608-1:2000医疗使用第1部分：笔式注射器要求和测试方法，笔式注射器。IEC 60068-2-30:1980, Environmental testing- Part2: Test Db and guidance: Damp heat, cyclic(12+12-hour cycle)IEC60068-2-30:1980环境试验第2部分：试验Db和指导：湿热，循环（12+12小时循环）3 Terms and definitions3术语和定义For the purposes of this part of ISO 11608, the following terms and definitions apply.对于这部分ISO11608的目的，下列术语和定义适用。The nomenclature of some components of a needle for a pen-injector is given in Figure1.图1给出了一些笔式注射器用针的组件命名。3.1Primary container初包装That part of the packaging which maintains sterility of the needle保持针无菌的包装部分NOTE the primary container may serve as a needle shield.注，出包装可以作为针的护套。3.2 Unit container单元包装Package intended for customer use为让客户使用准备的包装3.3 Seal封口Removable barrier which is intended to maintain the sterility of the needle inside the primary container可移除的屏障，用来维持初包装内针的无菌性Key1 seal1封口2 means of needle assembly attachment2 针组合附件装置3 needle hub3 针座4 primary container4 初包装5 Needle shield5 针护套6 needle tube6 针管7 jointing medium ( if used)7 联接剂（若采用）Figure 1 Schematic presentation of needle assembly for pen-injectors4 Requirements4 要求4.1 Colour coding4.1 颜色标识If colour coding is used for designation of the diameter of the needle ,the colour coding shall be in accordance with the requirements of ISO 6009.如果颜色编码被用于指定的针的直径，颜色编码应按照ISO6009的要求。4.2 Materials材料The needle should be made of tubing materials in accordance with ISO 683-13.制造针管的材料应满足ISO 683-134.3 Dimensions4.3 尺寸4.3.1 General4.3.1 通用要求The tubing diameters should be in accordance with the requirements given in Table of ISO 9626:1991.针管的尺寸应满足ISO 9626：1991给出的要求The dimensions of attachment part of the needle shall be such that the needle fits and functions with pen-injectors which are in accordance with ISO 11608-1.（组合）附件的尺寸应满足，针和符合ISO11608-1的笔式注射器配套。4.3.2 Type A needlesA型针Type A needles shall fit the test apparatus specified in 7.2 and function with pen-injectors designated and labelled to be used with Type A needles.A型针应适合7.2描述的试验装置，和笔式注射器（指定并标明与A型针配套的）一起使用。The length(l2) of the cartridge-end of the needle shall be within 3.50 mm to 7.25 mm (see Figure 1).针管笔芯端的长度(l2) 应在3.5mm至7.25mm范围内。The tolerance of the length (l1) of the patient-end of the needle shall be 1.25 mm of the length specified by the manufacturer (see Figure1).病人端针管长度(l1)应是制造商规定长度的1.25mm4.3.3 Non-Type A needles非A型针Non-Type A needles shall fit and function with identified pen-injectors designed and labeled to be used with the particular non-Type A needle.非A型针应适用于特定的笔式注射器（指定并标明与非A型针配套的）The length(l2) of the cartridge-end shall ensure adequate penetration of the cartridge seal when mounted on the pen-injector for which it is intended.笔芯端的长度(l2)应保证能刺穿对应的笔芯。The tolerance on the length(l1) of the patient-end of needle shall be 1.25 mm of the length specified by the manufacturer.病人端针管长度(l1)应是制造商规定长度的1.25mm4.4 Patency of lumen4.4 官腔通畅The needle tube shall have a patency such that a style, having a diameter equivalent to (802)% of the inner diameter of the tube, will pass through freely.针管应通畅，具有相当于80%2的管子内径时，可以自由地通过。4.5 needle points针尖When examined under2.5 magnification, needle points shall appear sharp and free from feather edges, burrs and hooks.2.5倍下检查时，针尖应呈现尖锐，无毛边，毛刺和挂钩。The needle point at the cartridge end shall be designed so as to minimize coring and fragmentation when penetrating the cartridge septum.笔芯端的针尖应设计满足，穿刺笔芯塞的时候最小化产生落屑。4.6 Freedom from defects4.6 避免缺陷The needle tube shall fulfill the requirements of 11.3 in ISO 7864:1993.针管应满足ISO7864:1993 11.3的要求（用正常或矫正视力观察时，针管应平直，有整齐的截面和壁厚）4.7 Lubrication4.7 润滑剂If the needle tube is lubricated, the lubricant shall not, under normal or corrected-to-normal vision, be visible as droplets of fluid on the outside or inside surface of the needle tube.如果针管经过润滑，那么在正常或矫正视力下，针管的内外表面无微滴形成。4.8 Dislocation of measuring point at the patient-end of Type A needles测量A型针病人端针尖的偏差The dislocation of the cannula point at the patient-end shall be in accordance with table 1, when tested in accordance with clause 8.按第8章检测时，病人端的针尖的偏差应符合表1.Table 1 Maximum allowable dislocation at the patient-end of type A needlesPatient-end needle lengthl1mmMaximum allowable dislocation最大允许偏差（长度的偏差）dmaxmm80.9121.1161.4other0.07l1+0.34.9 bond between hub and needle tube针管和针座的联接The union of the hub and needle tube shall not break when tested in accordance with clause 9.按第九章检测时，针管和针座的联接部位不应损坏。4.10 Unscrewing torque of the needle针的扭力When tested in accordance with clause 10,the unscrewing torque of needles that require unscrewing shall be less than 0.1 N*m按第10章检测时，针的扭力应不少于0.1N*m4.11 ease of assembly/disassembly易装配/拆卸The attachment of the needle shall be possible without removing the needle from its opened primary container.不把针从初包装中移出，针的附件也是可用的。4.12 sterilityThe needle in its primary container shall have been subjected to validated sterilization process.4.12 无菌初包装内的针应由确认过的灭菌过程进行灭菌。5 抽样Select 350 needles.抽取350支针。Use 50 needles for the first sample test cycle. The needle type in question is rejected if two or more needles do not meet the test criteria. However the needle type cannot be accepted on this first sample only.用50支针进行第一轮样品检测。如果2支或更多的针不符合检测标准，这批有问题的针不可接受。但该针式不可只通过第一批样品检测就被接受。If the needle type is not rejected on the first sample test cycle, test cycle a second sample of 50 needles. The batch will be rejected if three or more needles fail the test. If no needles fail the test ,the needle type is accepted.如果第一轮检测不可以接受，则进行第二轮50支样品的检测。如果3支或以上样品不合格，该批拒收。如果没有样品不合格，该针式可以接受。If one or two needles fail the test, select a third sample of 50needles to test, and continue down the table, using the acceptance and rejection test criteria shown in Table 2.如果有1到2支针检测不合格，选择第三批50支样品继续测试，使用表2的接受和拒收准则。 Table 2Sampling plan and acceptance/rejection criteriaaSample number样品编号Sample size 样品数量Cumulative sample size累积样品数量Acceptance criteria(numbers)接受标准Rejection criteria(numbers)拒收标准15050See foot noteb（见注b）2250100033501500345020014550250246503003575035045a the numbers in the table are derived from ISO 2859-1.本表中的数据来源于ISO2859-1（GBT 2828.1）b Acceptance not permitted at this stage. 本阶段不允许接受。大概意思是，必须接受两轮或以上的检测。即使第一轮全部合格，也进行第二轮，然后根据总的不合格数。6 preconditioning of needles针的预处理6.1 Preconditioning in dry heat atmosphere6.1 在干热空气中预处理The needle within its primary container is placed in a test chamber for at least 96h in the following hot atmosphere:带初包装的针放置在如下条件的空气中至少96h：n Temperature: (70 2)温度：（702）n Relative humidity: (5010)%相对湿度：（5010）%6.2 Preconditioning in cold storage atmosphere6.2 在冷藏空气中预处理The needle within its primary container is placed in a test chamber for at least 96h in the following cold atmosphere:带初包装的针放置在如下条件的空气中至少96h：n Temperature: (-403)温度：（-403）6.3 Preconditioning in cyclical atmosphere6.3 在循环空气中的预处理The needle within its primary container is placed in a test chamber. Conditioning in accordance with IEC 60068-2-30 is carried out as follows:将带初包装的针放在试验盒中，根据IEC 60068-2-30执行如下处理：n Variant 1( see IEC 60068-2-30:1980, figure 2a)不同的1（见IEC 60068-2-30:1980，图2a）n Upper temperature:(552)；and上限温度：（552）；n 6 cycles.6个循环NOTE The relevant clauses of IEC 60068-2-30:1980 are: clauses3,6 and 8.IEC 60068-2-30:1980中相关的章节是第3,6,8章。7 Standard atmosphere and apparatus for tests检测用标准空气和仪器7.1 standard test atmosphere7.1 标准测试空气Unless otherwise specified, measurements shall be performed in the following atmosphere:除非另有说明，应在以下空气中进行测量：n Temperature: from 18 to 28；温度：18至28n Relative humidity: from 25% to 75%;相对湿度：25%至75%After having been subjected to storage for at least 4h in this atmosphere.在以上环境中至少存放4h。7.2 test apparatus测试装置The dimensions of the test apparatus shall be in accordance with Figure 2.测试装置的尺寸应符合图2.Figure2 Test apparatus for Type A needles图2 A型针的测试装置8 Determination of dislocation of measuring point at the patient-end of Type A needles A型针病人端计量点偏移的测量Select samples in accordance with clause 5.按第5章选择样品Tighten the needle to the test apparatus (see Figure 2) with a torque of (0.070.01)Nm.用（0.070.01）Nm的扭矩将针固定在测试装置（如图2）上Place the test apparatus upon a “V-block” that it affixed to the cross-slide of an optical comparator.测试装置安置在一个V型板上，使其贴在光学测长仪的十字槽上。Align the top edge of the cylindrical part of the test apparatus outer diameter with the x-axis of the comparator。用测长仪的x-轴将测试装置的圆柱顶端的外径排列整齐，Move the “V-block” half the outer diameter of the test apparatus upwards, which will align the test apparatus centerline with the x-axis of the comparator.向上移动V型板，距离为测试装置外径的一半，会使测试装置的中心线和测长仪的X轴对齐。Rotate the test apparatus by hand and record the maximum dislocation (positive or negative) of the centre of the lumen at the level of the measuring point shown in Figure 3 relative to the x-axis of the comparator.用手旋转测试装置，并记录管腔中心线上计量点相对于测长仪X轴的最大偏移距离（正或负）Key1 Measuring point1 计量点Figure 3 Point on the needle for measurement of dislocation9 Bond between hub and needle tube9 针管和针座的连接Select samples in accordance with clause 5.按第5章选择样品Attach the needle with a torque of ( 0.070.01)Nm to the test apparatus specified in 7.2 (see Figure 2) (in the case of Type A needles) or to each pen-injector for which it is intended (in the case of non-Type A needles ) and in both situations in accordance with the instructions for use.用( 0.070.01)Nm扭矩将针固定到7.2中规定的测试装置（见图2）(如果是A型针)，或者与其匹配的笔式注射器（不是A型针）。两种情况都应符合使用说明。Pull the needle tube with a force in accordance with ISO 7864 applied at the patient-end of the needle. Pull in the direction of the test apparatus or pen-injector axis for 5s.按ISO 7864 （GB 15811 注射针的标准）的要求对针管施加拉力，沿测试装置或笔式注射器的轴向，持续5秒。Repeat the test with new needles after preconditioning the needles in accordance with 6.1, 6.2 and 6.3.对经过6.1,6.2,和6.3所述预处理的新的针管重复试验。10 Unscrewing torque of the needle针的螺旋扭矩Select samples in accordance with clause 5.按第5章选择样品。Screw the needle on the test apparatus/pen-injector with a torque of (0.070.01)Nm.用(0.070.01)Nm 的扭矩将针旋紧到测试装置或者笔式注射器。Leave each needle in place after attachment for at least 1 min. unscrew the needle and note the maximum torque required of unscrewing the needle.针装好后单独放置1分钟以上，反旋针并记录最大旋出扭矩。11 Packaging包装Each needle shall be sealed in primary container. One or more primary containers shall be packaged in a unit container.每支针都应密封在初包装中。一个或多个初包装集合在一个单元包装中。The materials of the primary container should not have detrimental effects on the contents. The materials and design of this container should ensure:初包装的材料不应对产品有不利影响。材料和包装的设计应确保：a) Maintenance of sterility of the contents under normal handling and storage;通常处理和储存条件下，对内含物无菌的保持性。b) Minimum risk of contamination of the contents during removal from the container;去除包装时对内容物最小的污染风险。c) That when the seal is removed there is no interference with the subsequent assembly of the needle and pen-injector/cartridge;打开密封后，对后面针与笔试注射器的装配没有干扰。d) Adequate protection of the contents during normal handling , transit and storage;在常规处理，运输和储存中，对内容物能提供足够的保护。e) That once opened, the container cannot be resealed, and it should be obvious that the container has been opened.一经开启，包装不能被再密封，并且显示为已开启。12 Information supplied by the manufacturer制造商提供的信息12.1 General12.1 综合The needle shall be accompanied by sufficient information to use it safely, taking into account the training and knowledge of the potential users, and to indentify the manufacturer.针应附有足够的信息来保证使用安全，考虑到潜在用户的训练和知识，已经制造商的识别性。Instructions for use shall be included in the unit container, unless the needles can be used safely without any such instructions.使用说明应包含在单元包装中，除非针在没有任何说明的情况下安全使用。12.2 Marking标签12.2.1 General综合Any marking on the primary or unit container that is essential for the safe use of the device shall be visible and easily legible.初包装或单元包装上的任何关于安全使用的必要信息，都应该是可见而容易阅读的。12.2.2. Marking on primary container12.2.2 初包装的标签The marking on the primary container shall comprise at least the following particulars:初包装上的标签至少包括以下项目：a) Name or trade name of the manufacturer;制造商的名称或贸易名称NOTE A trademark or logo may be sufficient to identify the manufacturer;注 商标或logo足够辨识制造商。b) The details necessary for the user to identify the needle, including the designated metric size, in accordance with the following expression: o.d. x l where o.d. is the nominal outside diameter of the needle tube, in millimeters, and l is the nominal length of the needle tube, in millimeters (e.g. 0.33mm x 12.7mm);让用户分辨针的必要细节，包括标明尺寸，按以下方式：o.d.外径 x l长度，o.d.是指针管的外径，毫米单位，l是只针管长度，毫米单位（例如 0.33mm x 12.7mm）c) The word” sterile” or symbol“无菌“字样或标签d) Batch code or lot number;批号e) If possible , the expiry date (year and month, expressed for instance as YYYY-MM, e.g.:1996-12).如果可以，有效日期（年和月，以YYYY-MM的方式，例如1996-12）If it is not possible to mark the expiry date on the primary container, it shall appear on the unit container.如果初包装不标明有效日期，那么应该在单元包装上标明。12.2.3 Marking on unit container单元包装的标签The marking on the unit container shall comprise at least the following particulars:单元包装上的标签至少包括以下项目：a) The name and address of the manufacturer;制造商的名称或贸易名称b) The details necessary for the user to identify the needle, including:用户辨识针的必要细节，包括n The designated metric size, in accordance with 12.2.2; and标明尺寸，和12.2.2一样n For Type A needles, the designation:”TYPE A”; or对于A型针，应标明“A型”n For non-Type A needle:”Use only with followed by the information required in 12.2.3 c)”;or对于非A型针，按12.2.3c的要求。n For needles fulfilling the requirements of Type A needles in accordance with the requirements of this part of ISO 11608 and also designed to fit and function with pen-injectors for non-Type A needles, the designation “TYPE A”(followed by information that the needles can be use