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EVS-EN ISO 11607-2:2020

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

General information
Valid from 03.02.2020
Base Documents
ISO 11607-2:2019; EN ISO 11607-2:2020

Standard history

Status
Date
Type
Name
15.11.2023
Main + amendment
01.11.2023
Amendment
01.07.2022
Amendment
01.07.2022
Main + amendment
03.02.2020
Main
02.08.2017
Main
ISO 11607-2 sets out requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. The standard can be used in the medical industry, health care facilities or wherever medical devices are packaged and sterilized. ISO 11607-2 helps to ensure that the medical device can be sterilized and remain sterile in storage or in transport conditions. It is also important that medical devices delivered in a sterile state are manufactured, packed and sterilized by validated methods.

Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as an accessory or a component of a medical device. In many parts of the world preformed sterile barrier systems are considered medical devices. ISO 11607-2 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug or device combinations.

The international standard has been approved in Europe as EN ISO 11607-2:2020 without any changes and it supersedes EN ISO 11607-2:2017.
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