项目
胰岛素注射器
21 CFR 880.5860
针式胰岛素注射笔
21 CFR 880.5570
管控分类
Class II
Class II
性能测试
ISO 8537
ISO 7864
ISO 9626
ISO 23908
ISO11608-1
ISO 11608-2
ISO 7864
ISO 9626
ISO 23908
生物相容性
ISO 10993-1
ISO 10993-4
ISO 10993-5
ISO 10993-7
ISO 10993-10
ISO 10993-11
USP<788>:Particulate Matter for injection
USP<85>:Bacterial Endotoxins Test
ISO 10993-1
ISO 10993-4
ISO 10993-5
ISO 10993-7
ISO 10993-10
ISO 10993-11
USP<788>:Particulate Matter for injection
USP<85>:Bacterial Endotoxins Test
密封无菌包装
ASTM F88
ASTM F1929
ASTM F1140
DIN 58953–6
ASTM F88
ASTM F1929
ASTM F1140
DIN 58953–6
运输包装
ASTM D4169
ASTM D4169
老化验证
ASTM F1980
ASTM F1980
标签
21 CFR part 801
21 CFR part 801
