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AAMI/ISO TIR17665-3:2014(R2016)

Current

Current

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

Available format(s)

PDF

Language(s)

English

Published date

11-11-2016

US$285.00
Excluding Tax where applicable
Summarise this standard

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

US$285.00
Excluding Tax where applicable