发布时间 : 星期五 文章ISO 11608-2 2000中英对照版更新完毕开始阅读
Pen-injectors for medical use- Part 2:
Needles – Requirements and test methods
1 Scope
1 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 references
2 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 definitions 3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。 3.1
Primary 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
Key 1 seal 1封口
2 means of needle assembly attachment 2 针组合附件装置
3 needle hub 3 针座
4 primary container 4 初包装
5 Needle shield
5 针护套 6 needle tube 6 针管
7 jointing medium ( if used)
7 联接剂（若采用）
Figure 1 – Schematic presentation of needle assembly for pen-injectors
4 Requirements
4 要求
4.1 Colour coding 4.1 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 683-13 4.3 Dimensions
4.3 尺寸 4.3.1 General 4.3.1 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 needles A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±1.25mm
4.3.3 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±1.25mm
4.4 Patency of lumen 4.4 官腔通畅
The needle tube shall have a patency such that a style, having a diameter equivalent to (80±2)% 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 under×2.5 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 defects 4.6 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 Lubrication 4.7 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 needles Patient-end needle length Maximum allowable dislocation