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AAMI ISO TIR 17665-3:2014

Superseded

Superseded

View Superseded by

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

12-31-2012

Superseded date

07-30-2017

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.

DocumentType
Standard
Pages
65
ProductNote
Reconfirmed 2014
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

Standards Relationship
ISO/TS 17665-3:2013 Identical

⚠

A newer version of this standard is available.

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