EN ISO 11607-1:2020/A11:2022
终端无菌医学设备的包装.第1部分:材料、消毒阻挡系统和包装系统的要求 包含修改件A11,2022

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

作废

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标准号

EN ISO 11607-1:2020/A11:2022

发布

2022年

发布单位

欧洲标准化委员会

当前最新

EN ISO 11607-1:2020/A11:2022

 

 

适用范围

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

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