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AAMI TIR39:2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

GUIDANCE ON SELECTING A MICROBIAL CHALLENGE AND INOCULATION SITES FOR STERILIZATION VALIDATION OF MEDICAL DEVICES

Available format(s)

Hardcopy , PDF

Superseded date

31-08-2021

Superseded by

AAMI TIR39:2009(R2017)

Language(s)

English

Published date

01-01-2017

Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Microbial challenge types and
  criteria for selection
5 Selection of product, inoculation
  site, and process for inoculation
6 Testing and assessment of
  inoculated product
7 Considerations for the use of
  liquid inoculum
Bibliography

Gives guidance for selecting the appropriate type of microbial challenge to use in a sterilization validation process, the selection of appropriate inoculation sites, and the methods for inoculation and recovery of inoculated microorganisms from these sites.

DocumentType
Standard
Pages
21
ProductNote
Reconfirmed 2009
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
AAMI ISO TIR 11139 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY
ANSI/AAMI ST55:2016 TABLE-TOP STEAM STERILIZERS
AAMI ISO 14161 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS
ANSI/AAMI/ISO 11138-1:2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
AAMI/ISO 13485:2016 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES

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