GB 8369.1-2019 一次性使用输血器 第1 部分:重力输血式
简介
GB 8369.1-2019 代替 GB 8369—2005
一次性使用输血器 第1 部分:重力输血式 III
Transfusion sets for single use—Part 1: Gravity feed (ISO 1135-4:2015 Transfusion equipment for medical use—— Part 4： Transfusion sets for single use»gravity feed, MOD)
2019-10-14 发布
2021-05-01 实施
目 次
前言........................................1
1范围...........................................1
2规范性引用文件......................................1
3通用要求.........................................1
3.1输血器组件的命名..................................1
3.2无菌的保持.....................................1
4材料............................................2
5物理要求..........................................3
5.1微粒污染......................................3
5.2泄漏........................................3
5.3拉伸强度......................................3
5.4输血插口穿刺器...................................3
5.5管路.......................................3
5.6血液及血液成分过滤器................................3
5-7滴斗与滴管.....................................4
5.8流量调节器.....................................4
5.9血液及血液成分的流速................................4
5.10注射件......................................4
5.11外圆锥接头....................................4
5.12保护套......................................4
6化学要求..........................................4
6.1 还原物质（易氧化物）...............................4
6.2金属离子......................................4
6.3 酸威度滴定....................................5
6.4 蒸发残渣.....................................5
6.5浸提液紫外吸光度..................................5
6.6环氣乙烷残留量...................................5
7生物要求.........................................5
7.1总则........................................5
7.2无菌.......................................5
7.3热原........................................5
7.4溶血........................................5
7.5毒性........................................5
7.6血液成分残留评定..................................5
7.7血液成分损伤评定..................................6
8标志...........................................6
8-1 总则...................................6 8.2单包装.......................................6
8-3货架或多单元包装..................................6
9包装...........................................7
10处置..........................................7
附录A （规范性附录）物理试验 ..............................8
附录B （规范性附录）化学试验..............................10
附录C （规范性附录）生物试验..............................12
附录D （资料性附录）设计与实施指南...........................13
附录E （资料性附录）本部分与ISO 1135-4,2015的技术性差异及其原因 ....15
参考文献.........................................17
图1输血器示例.......................................2
图2输血插口穿刺器尺寸...................................3
表A.1微粒数污染评价...................................8
&E.1本部分与ISO 1135-4,2015的技术性差异及其原因 ...........15
GB 8369.1-2019 代替 GB 8369—2005
一次性使用输血器 第1 部分:重力输血式 III
Transfusion sets for single use—Part 1: Gravity feed (ISO 1135-4:2015 Transfusion equipment for medical use—— Part 4： Transfusion sets for single use»gravity feed, MOD)
2019-10-14 发布
2021-05-01 实施
目 次
前言........................................1
1范围...........................................1
2规范性引用文件......................................1
3通用要求.........................................1
3.1输血器组件的命名..................................1
3.2无菌的保持.....................................1
4材料............................................2
5物理要求..........................................3
5.1微粒污染......................................3
5.2泄漏........................................3
5.3拉伸强度......................................3
5.4输血插口穿刺器...................................3
5.5管路.......................................3
5.6血液及血液成分过滤器................................3
5-7滴斗与滴管.....................................4
5.8流量调节器.....................................4
5.9血液及血液成分的流速................................4
5.10注射件......................................4
5.11外圆锥接头....................................4
5.12保护套......................................4
6化学要求..........................................4
6.1 还原物质（易氧化物）...............................4
6.2金属离子......................................4
6.3 酸威度滴定....................................5
6.4 蒸发残渣.....................................5
6.5浸提液紫外吸光度..................................5
6.6环氣乙烷残留量...................................5
7生物要求.........................................5
7.1总则........................................5
7.2无菌.......................................5
7.3热原........................................5
7.4溶血........................................5
7.5毒性........................................5
7.6血液成分残留评定..................................5
7.7血液成分损伤评定..................................6
8标志...........................................6
8-1 总则...................................6 8.2单包装.......................................6
8-3货架或多单元包装..................................6
9包装...........................................7
10处置..........................................7
附录A （规范性附录）物理试验 ..............................8
附录B （规范性附录）化学试验..............................10
附录C （规范性附录）生物试验..............................12
附录D （资料性附录）设计与实施指南...........................13
附录E （资料性附录）本部分与ISO 1135-4,2015的技术性差异及其原因 ....15
参考文献.........................................17
图1输血器示例.......................................2
图2输血插口穿刺器尺寸...................................3
表A.1微粒数污染评价...................................8
&E.1本部分与ISO 1135-4,2015的技术性差异及其原因 ...........15
推荐下载
精品资源合集一键下载