AAMI ISO 11135-1 : 2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
English
01-01-2007
10-09-2015
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
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement - Control of
nonconforming product
5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Material effects
5.4 Environmental considerations
6 Process and equipment characterization
6.1 Process characterization
6.2 Equipment characterization
7 Product definition
7.1 General
7.2 Product safety and performance
7.3 Microbiological quality
7.4 Documentation
8 Process definition
9 Validation
9.1 Installation qualification
9.2 Operational qualification
9.3 Performance qualification
9.4 Varying load configurations
9.5 Review and approval of validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
12.2 Maintenance of equipment
12.3 Requalification
12.4 Assessment of change
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) General guidance
Bibliography
Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices.
| Committee |
WG 01
|
| DevelopmentNote |
Supersedes AAMI ISO 11135:1994. (08/2007)
|
| DocumentType |
Standard
|
| Pages |
63
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 11135-1:2007 | Identical |
A newer version of this standard is available.
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