GB 15810-2019 代替 GB 15810—2001
一次性使用无菌注射器
Stwile syringes for single use (ISO 7886-1 ：2017♦ Sterile hypodermic syringes for single use一 Part 1: Syringes for manual use > MOD)
2019-10-14 发布
2020-11-01 实施
目 次
前言......................................1
引言.....................................1
1范围.....................................1
2规范性引用文件................................1
3术语和定义..................................1
4命名.....................................2
5物理要求...........................................3
5.1外观.........................................3
5.2刻度容量允姜......................................4
5.3刻度标尺........................................4
5.4外套..........................................6
5.5活塞组件.......................................6
5.6锥头..........................................6
5.7性能..........................................6
6化学要求...........................................7
6.1酸碱度........................................7
6.2可萃取金属含匿.....................................7
6.3易氧化物........................................7
6.4环氧乙烷残留量.....................................7
7生物要求............................................8
7.1总则..........................................8
7.2无菌...........................................8
7.3细菌内毒素........................................8
8包装..............................................8
8-1初包装..........................................8
8-2 中包装........................................8
9标志..............................................8
9.1 总则..........................................8
9- 2初包装.........................................8
9.3 中包装.........................................9
9.4大包装..........................................9
9.5运输包装材料.......................................9
10贮存...........................3.................9
附录A《资料性附录）本标准与ISO 7886-1,2017相比的结构变化情况..........10
附录B （规范性附录）容量允姜和残留容量的试验方法.......................11
附录C《规范性附录）注射器受正向压力时活塞或密封圈处泄漏的试验方法.........13
附录D （规范性附录）注射器在抽负压时活塞或密封圈处泄漏及活塞与芯杆分离的试验方法……14
附录E （规范性附录）滑动性能试竅方法.......................16
附录F （规范性附录）外套与活塞组件配合的试验方法.................19
附录G （规范性附录）萃取液制备及试验方法.....................20
附录H （资料性附录）设计和材料的指南.......................21
参考文献.......................................22