GSO ISO 11607-2:2021

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

GSO ISO 11607-2:2021 发布历史

GSO ISO 11607-2:2021由GSO 发布于 2021-07-01。

GSO ISO 11607-2:2021在国际标准分类中归属于: 11.080.30 消毒封装。

GSO ISO 11607-2:2021 的最新版本是哪一版？

最新版本是 GSO ISO 11607-2:2021 。

GSO ISO 11607-2:2021的历代版本如下：

• 2021年 GSO ISO 11607-2:2021

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

标准号

GSO ISO 11607-2:2021

发布

2021年

发布单位

GSO

当前最新

GSO ISO 11607-2:2021

 

 

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