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  • AAMI TIR39:2009(R2017)

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    GUIDANCE ON SELECTING A MICROBIAL CHALLENGE AND INOCULATION SITES FOR STERILIZATION VALIDATION OF MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  27-04-2023

    Language(s):  English

    Published date:  19-10-2017

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Document Type Technical Report
    Product Note Reconfirmed 2017
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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