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  • AAMI TIR40 : 2018

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON DOSE SETTING UTILIZING A MODIFIED METHOD 2

    Available format(s):  Hardcopy, PDF

    Superseded date:  09-04-2024

    Language(s):  English

    Published date:  31-01-2018

    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
    1 Scope
    2 Normative References
    3 Abbreviations, terms, and definitions
    4 Modified Method 2 - Application for method
    5 Modified Method 2: Dose setting using fraction positive
      information from incremental dosing to determine an
      extrapolation factor
    6 Procedure for Modified Method 2A
    7 Procedure for Modified Method 2B
    8 Auditing sterilization dose
    9 Worked examples
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines a modification to Methods 2A and 2B of ANSI/AAMI/ISO 11137-2 that reduces the number of incremental doses needed to determine the minimum dose required to achieve a predetermined sterility assurance level (SAL).

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

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    AAMI ISO 11137-2 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    AAMI ISO TIR 11139 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY
    AAMI ST32 : 1991 GUIDELINE FOR GAMMA RADIATION STERILIZATION
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