ANSI/AAMI/ISO 11135:2014
Current
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
English
07-27-2015
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 11135-1:2007
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
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 (normative) - Determination of lethal
rate of the sterilization process - Biological
indicator/bioburden approach
Annex B (normative) - Conservative determination
of lethal rate of the sterilization
process - Overkill approach
Annex C (informative) - Temperature sensors, RH
sensors and biological indicator numbers
Annex D (informative) - Guidance on the application of
the normative requirements
Annex E (normative) - Single Lot Release
Bibliography
This document specifies requirements for the development, validation, and routine control of an ethylene oxide
sterilization process for medical devices.
| Committee |
WG 01
|
| DevelopmentNote |
Supersedes AAMI ST27 and AAMI TIR 1 (07/2002) Supersedes AAMI ISO 11135-1 & AAMI ISO TIR 11135-2. (09/2015)
|
| DocumentType |
Standard
|
| ISBN |
1-57020-596-5
|
| Pages |
109
|
| ProductNote |
New child AMD 1 2018 is added
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11135:2014 | Identical |
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