AAMI/ISO TIR17665-2:2009(R2016)
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
English
19-06-2016
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO TIR17665-2:2009
AAMI inclusion to ISO TIR17665-2:2009
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) - Evaluation of a sterilization
process primarily based on the
measurement of physical parameters
Annex B (informative) - Evaluation of a sterilization
process primarily based on
biological inactivation and an
accompanying mechanical air
removal procedure
Annex C (informative) - Temperature and pressure of
saturated steam for use in
moist heat sterilization
Annex D (informative) - Special considerations for health
care settings
Annex E (informative) - Index of normative clauses/subclauses
of ISO 17665-1 and cited references
or related guidance given in ISO
17665-1 and ISO/TS 17665-2
Bibliography
AAMI/ISO TIR17665-2 provides guidance for validation and routine control of moist heat sterilization processes for medical devices.
| DevelopmentNote |
Supersedes AAMI TIR13. Together with AAMI ISO 17665-1, it supersedes AAMI ISO 11134. (07/2009)
|
| DocumentType |
Standard
|
| ISBN |
1-57020-349-0
|
| Pages |
66
|
| ProductNote |
Reconfirmed 2016
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO/TS 17665-2:2009 | Identical |
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