ISO 8537返回 Back

Test item测试名称:

ISO 8537 Sterile insulin syringe for single use

ISO 8537 一次性使用无菌胰岛素注射器


Test info测试内容:

Clause / Test Requirement

5.4.1 General 总则

5.4.2 acidity and alkalinity 酸碱度

5.4.3 Limits for extractable metals 可萃取金属含量

5.5 Limits for extractable metals 润滑剂

5.6 Dimensions 尺寸

5.7.1 General 总要求

5.7.2 Fit of plunger stopper in barrel 柱塞在桶内的配合

5.8.1 Conical fitting 锥形接头

5.8.2 Position of nozzle on end of barrel 锥头的位置

5.9 Needle tubing and Needle 针管和针

5.9.3 Bond between hub and needle tube 连接牢固度

5.10 Standard test environmental conditions 检测环境

5.11.1 Dead space 残留容量

5.11.2 Freedom from leakage at needle 针管泄漏

5.11.2 Freedom from leakage past plunger stopper 漏液漏气


Lead time测试周期: 15个工作日


Sample size送样规格: 完整样品50套


Sample for reference参考图片:

Responsive image


Sample report样本报告: