Buy I.S. EN ISO 11607-2:2020

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

Amended by

I.S. EN ISO 11607-2:2020/A1:2023

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

23-01-2020

Publisher

National Standards Authority of Ireland

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€33.00

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Dates of withdrawal of national standards are available from NSAI.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Validation of packaging processes
6 Assembly
7 Use of reusable sterile barrier systems
8 Sterile fluid-path packaging
Annex A (informative) Process development
Bibliography

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized.

Committee	CEN/TC 102
DocumentType	Standard
Pages	30
ProductNote	The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 11607-2:2017 & LC:2017

Standards	Relationship
EN ISO 11607-2:2020	Identical
ISO 11607-2:2019	Identical
DIN EN ISO 11607-2:2020-05	Equivalent
UNE-EN ISO 11607-2:2020	Equivalent
BS EN ISO 11607-2:2020	Equivalent

Frequently Asked Questions

No — I.S. EN ISO 11607-2 is an Irish standard published by National Standards Authority of Ireland (NSAI), with its listed region as Ireland.

I.S. EN ISO 11607-2 is used by medical device manufacturers and packaging operations maintaining sterility through distribution and storage. It is an Irish standard published by National Standards Authority of Ireland (NSAI).

I.S. EN ISO 11607-2 is National Standards Authority of Ireland (NSAI)'s standard for terminally sterilised medical device packaging, while I.S. EN ISO 11137-1 covers radiation sterilisation of healthcare products (Ireland). I.S. EN ISO 11607-2 specifies requirements for sterile barrier systems and packaging process validation for terminally sterilised medical devices. I.S. EN ISO 11137-1 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation.

I.S. EN ISO 11607-2 specifies requirements for sterile barrier systems and packaging process validation for terminally sterilised medical devices. It is an Irish standard published by National Standards Authority of Ireland (NSAI).

I.S. EN ISO 11607-2 specifies requirements for sterile barrier systems and packaging process validation for terminally sterilised medical devices. In practice it is applied by medical device manufacturers and packaging operations maintaining sterility through distribution and storage.

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I.S. 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)

Table of Contents

Abstract

General Product Information

International Equivalents

Industry

Sub-Industry

Is I.S. EN ISO 11607-2 an Australian standard?

Who uses I.S. EN ISO 11607-2?

What is the difference between I.S. EN ISO 11607-2 and I.S. EN ISO 11137-1?

What does I.S. EN ISO 11607-2 cover?

What is I.S. EN ISO 11607-2 used for?