BS EN ISO 7864 一次性使用无菌注射针头要求和试验方法
Sterile hypodermic needles for single use — Requirements and test methods

Clause

Test Category

4

Requirement 要求

4.3

cleanliness清洁

4.4

Limits for acidity or alkalinity酸度或碱度的限制

4.5

Limits for extractable metals
(50pcs-chemical)可萃取金属的限制

4.6

Size designation大小指定

4.7

colour coding彩色编码

4.8

needle hub (ISO 80369-7)针毂(ISO 80369-7)

4.9

Needle cap (ISO 6009)针帽(iso6009)

4.10

Needle tube针形管

4.10.1

General(ISO 9626)一般 （ISO 9626）

4.10.2

Tolerances on length公差在长度

4.10.3

Freedom from defects自由的缺陷

4.10.4

Lubricant润滑剂

4.11

Needle point针点

4.12

Bond between hub and needle tube轮毂与针管之间的连接

4.13

Patency of lumen开放腔的

4.14

Sharps injury protection
( ISO 23908)锐器损伤的保护
(ISO 23908)

4.15

Sterility and biocompatibility不育性和生物相容性

5

Packaging包装

6

Labelling标签

Sample Size: 100pieces样本数量:100件

Turnaround Time: 9~11working days  周转时间:9~11个工作日

note: exclude the material characteristic注:不含材料特性
         Type 1:the hub without a locking fitting类型1:毂没有锁定配件
         Type 2: the hub has a locking fitting类型2:轮毂有一个锁定配件