AAMI ISO 11137-1:2006
Superseded
View Superseded by
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
English
01-01-2010
07-13-2019
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO
11137-1:2006
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
Describes requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
| Committee |
WG 02
|
| DevelopmentNote |
Supersedes AAMI ISO 11137 and AAMI TIR27. (03/2006) Supersedes AAMI ISO TIR 15843. (09/2009)
|
| DocumentType |
Standard
|
| Pages |
54
|
| ProductNote |
Reconfirmed 2006
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11137-1:2006 | Identical |
A newer version of this standard is available.
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