AAMI/ISO TIR17665-3:2014(R2016)
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
English
11-11-2016
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
ISO TS 13004:2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Product family (pf)
6 Processing category
7 Sterilization process parameters
8 Additional considerations
Annex A (informative) - Process parameters
Annex B (informative) - Characterization of a procedure
set - Examples
Annex C (informative) - Designating a processing category
Annex D (informative) - Processing categories- Examples
Bibliography
Gives guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and aligning it to a processing category for a specific moist heat sterilization process.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-571-2
|
| Pages |
65
|
| ProductNote |
Reconfirmed 2016
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO/TS 17665-3:2013 | Identical |
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