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
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）
Key
1 Measuring point 1 计量点
Figure 3 – Point on the needle for measurement of dislocation
9 Bond between hub and needle tube
9 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 ( 0.07±0.01)N·m 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( 0.07±0.01)N·m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 (0.07±0.01)N·m. 用(0.07±0.01)N·m 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 General
12.1 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 container 12.2.2 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
d) Batch code or lot number;
标签
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
? The designated metric size, in accordance with 12.2.2; and 标明尺寸，和12.2.2一样
? For Type A needles, the designation:”TYPE A”; or 对于A型针，应标明“A型”
? 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。
? 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 used with additional pen-injectors); 对于满足ISO 11608本部分要求的A型针，以及设计用于适合并和笔式注射器配套的非A型针，标记“TYPE A”（说明针可以用于附加的笔式注射器）
c) Information on the pen-injector(s) with which the needle assembly is intended to be used (if
non-Type A identified pen-injector(s) shall be listed);
说明针要和笔式注射器装配使用（如果是非A型针，应列明指定的笔式注射器）
d) The words “FOR SINGLE USE”, or the symbol given in ISO 7000/1051 may alternatively be
used;
“一次性使用”字样或者ISO 7000/1051中的标志。
e) The word ”sterile” or the symbol
“无菌”字样或
f) Batch code or lot number;
标志。
批号
g) Expiry date , if any (year and month, expressed for instance as YYYY-MM, 1996-12) 有效期，（年和月，以YYYY-MM的方式，例如1996-12） h) Any special storage and/or handling conditions. 其他特殊的储存或处理要求。 12.3 Instructions for use
使用说明
The instructions for use, where given , shall contain at least the following particulars: 使用说明书应至少包含以下项目：
a) The information required in 12.2.3, except that the information regarding lot number, batch
code and expiry date can be omitted;
12.2.3要求的信息，除了关于批号、有效期的信息其他可以省略。
b) The details of all pen-injectors( either pen-injectors intended to be used with Type A needles
or indentified pen-injectors) and cartridges (either Type A cartridges or identified cartridges) with which the needle is intended to be used; 所有预期与针配套的笔式注射器的细节（不论是与A型针配套的，或是其他指定的笔式注射器），以及笔芯的细节（A型笔芯或其他指定的笔芯）
c) Information on the fixation of the needle to the pen-injector if the fixation procedure differs
from that given in the instructions for use for the pen-injector.
针与笔式注射器组装的方法，如果该方法和笔式注射器的使用说明有所不同。 注： Type A
Classification of needles and cartridges for pen-injectors which fulfil certain specific requirement providing interchangeability.
笔式注射器用针和笔芯的分类，满足某些特定要求，并且有互换性。（我理解就是类似六比一百的一种通用匹配结构。）