AAMI TIR17 : 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
English
01-01-2008
19-06-2019
Committee representation
Foreword
1 Scope
2 Definitions, symbols, and abbreviations
3 Selection of materials
4 Manufacturing process and design considerations
5 Material testing
6 Accelerated aging programs
Annex A (informative) - Radiation sterilization - Material
compatibility fundamentals
Annex B (informative) - Ethylene oxide sterilization - Material
compatibility fundamentals
Annex C (informative) - Moist heat sterilization - Material
compatibility fundamentals
Annex D (informative) - Dry heat sterilization - Material
compatibility fundamentals
Annex E (informative) - Hydrogen peroxide sterilization - Material
qualification fundamentals
Annex F (informative) - Nitrogen dioxide sterilization - Material
qualification fundamentals
Annex G (informative) - Peracetic acid (PA) vapor
sterilization - Material compatibility fundamentals
Annex H (informative) - Liquid peracetic acid
sterilization - Material compatibility fundamentals
Annex I (informative) - Hydrogen peroxideozone
sterilization - Material compatibility fundamentals
Annex J (informative) - Accelerated aging programs
Annex K (informative) - Example of a device evaluation process
Annex L (informative) - Material abbreviations
Bibliography
Gives guidance for health care product manufacturers in the selection and qualification of polymeric materials, ceramics, and metals for use in health care products sterilized by the following methods: - Radiation (gamma, electron beam, or x-ray) - Ethylene oxide (EO) - Moist heat (steam) - Dry heat - Hydrogen peroxide - Nitrogen dioxide - Vaporized peracetic acid - Liquid peracetic acid and - Hydrogen peroxide-ozone.
| DevelopmentNote |
Supersedes AAMI ST32 (07/2002)
|
| DocumentType |
Standard
|
| Pages |
96
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11137:1995 | Identical |
A newer version of this standard is available.
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