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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
None

Standard history

Status
Date
Type
Name
15.11.2023
Main + amendment
01.11.2023
Amendment
01.07.2022
Main + amendment
01.07.2022
Amendment
03.02.2020
Main
ISO 11607-1 describes requirements and test methods for materials, preformed sterile and sterile barrier systems, and packaging systems. This standard can be used by anyone in the healthcare industry or healthcare facilities.

The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavour. The device components and the packaging system should be combined to create a sterile medical device that performs efficiently, safely and effectively in the hands of the user.

This text also includes an amendment, where you can find:
— the relationship between EN ISO 11607-1and the essential requirements of Directive 93/42/EEC
— the relationship between EN ISO 11607-1 and the essential requirements of Directive 90/385/EEC
— the relationship between EN ISO 11607-1 and the essential requirements of Directive 98/79/EC.

The main text and the amendment can be found separately from the standard’s history. The international standard has been approved in Europe as EN ISO 11607-1:2020 without any changes and it supersedes EN ISO 11607-1:2017.
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