EVS-EN ISO 11607-1:2020+A11:2022

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

General information
Valid from 01.07.2022
Base Documents
ISO 11607-1:2019; EN ISO 11607-1:2020; EN ISO 11607-1:2020/A11:2022
Directives or regulations
Standard history
Main + amendment
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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