Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137- 1:2006/Amd 2:2018)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-08-2019

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (informative) Guidance
Bibliography

This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

Committee	TC 198
DocumentType	Standard
Pages	0
ProductNote	THIS STANDARD ALSO REFERS-EN 556-1 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 11137-1:2015

Standards	Relationship
EN ISO 11137-1:2015/A2:2019	Identical
EN ISO 11137-1:2015	Identical
ISO 11137-1:2006	Identical

View more information

US$76.74

Excluding Tax where applicable

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

Access your standards online with a subscription

Features

Simple online access to standards, technical information and regulations.
Critical updates of standards and customisable alerts and notifications.
Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

Get in touch with us

Log into your Account

I.S. EN ISO 11137-1:2015&A2:2019

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Category

Subcategory

Access your standards online with a subscription