ISO 11607-2:2019 Standard

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

Amended by

ISO 11607-2:2019/Amd 1:2023

Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

31-01-2019

Publisher

International Organization for Standardization

€130.00

Excluding VAT

Summarise this standard

AI-generated summary

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.

It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

Committee	ISO/TC 198
DocumentType	Standard
Pages	13
ProductNote	THIS STANDARD ALSO REFERS TO EN 13795-1,ANSI/AAMI ST65,ANSI/AAMI ST77,ANSI/AAMI ST90,ISO 11607-1:2018
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 11607-2:2006 ISO 11607-2:2006/Amd 1:2014

Standards	Relationship
SS-EN ISO 11607-2:2020	Identical
EN ISO 11607-2:2020	Identical
I.S. EN ISO 11607-2:2020	Identical
BS EN ISO 11607-2:2020	Identical
NEN-EN-ISO 11607-2:2020	Identical
ÖNORM EN ISO 11607-2:2022 12 01	Identical
IS/ISO 11607 : Part 2 : 2019	Identical
DS/EN ISO 11607-2:2020	Identical
DS/ISO 11607-2:2019	Identical
DS/ISO 11607-2:2019/Amd 1:2023	Identical
ÖNORM EN ISO 11607-2:2022 12 01	Identical
NF EN ISO 11607-2:2020	Identical
EN ISO 11607-2:2017	Identical
ABNT NBR ISO 11607-2:2024	Identical
DIN EN ISO 11607-2:2020-05	Identical
JIS T 0841-2:2026	Identical
UNE-EN ISO 11607-2:2020	Identical
BS EN ISO 11607-2:2017	Identical

Frequently Asked Questions

ISO 11607-2 specifies requirements for sterile barrier systems and packaging process validation for terminally sterilised medical devices. It is an international standard published by International Organization for Standardization (ISO).

ISO 11607-2 belongs to the topic area of terminally sterilised medical device packaging. It is an international standard published by International Organization for Standardization (ISO).

ISO 11607-2 is published by International Organization for Standardization (ISO). It is an international standard.

ISO 11607-2 is an international standard published by International Organization for Standardization (ISO), and is applied internationally rather than in a single country.

ISO 11607-2 is International Organization for Standardization (ISO)'s standard for terminally sterilised medical device packaging, while ISO 11137-3 covers radiation sterilisation of healthcare products (International). ISO 11607-2 specifies requirements for sterile barrier systems and packaging process validation for terminally sterilised medical devices. ISO 11137-3 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation.

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ISO 11607-2:2019

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

Industry

Sub-Industry

What is ISO 11607-2?

Which topic area does ISO 11607-2 belong to?

Which body issues ISO 11607-2?

Where does ISO 11607-2 apply?

What is the difference between ISO 11607-2 and ISO 11137-3?