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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
EN ISO 11607-1:2020/A11:2022
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.11.2023
Main + amendment
01.07.2022
Amendment
01.07.2022
Main + amendment
03.02.2020
Main

ISO 11607-1 describes requirements and test methods for materials, preformed sterile and sterile barrier systems, and packaging systems. EN ISO 11607-1:2020/A11:2022 modifies the European standard EN ISO 11607-1:2020. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history.

In this amendment 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

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Amendment

EVS-EN ISO 11607-2:2020/A11:2022

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Valid from 01.07.2022
Amendment

EVS-EN ISO 14971:2019/A11:2021

Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Valid from 15.12.2021
Amendment

EVS-EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 16.09.2021
Amendment

ISO 10993-18:2020/Amd 1:2022

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor
Newest version Valid from 11.05.2022