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  • AAMI ISO 11137-2 : 2013

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 2: ESTABLISHING THE STERILIZATION DOSE

    Available format(s):  Hardcopy, PDF

    Superseded date:  23-05-2019

    Language(s):  English

    Published date:  01-01-2013

    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
    Background of ANSI/AAMI adoption of ISO 11137-2:2013
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms, definitions and abbreviated terms
    4 Definition and maintenance of product families
       for dose setting, dose substantiation and
       sterilization dose auditing
    5 Selection and testing of product for establishing
       the sterilization dose
    6 Methods of dose establishment
    7 Method 1: dose setting using bioburden information
    8 Method 2: Dose setting using fraction positive
       information from incremental dosing to determine
       an extrapolation factor
    9 Method VD[max] - Substantiation of 25 kGy or 15 kGy
       as the sterilization dose
    10 Sterilization dose audit
    11 Worked examples
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10[-6].

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

    Committee WG 02
    Development Note Supersedes AAMI ISO 11137, AAMI TIR27 and AAMI ISO TIR 13409 (03/2006)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    AAMI TIR33 : 2005 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF A SELECTED STERILIZATION DOSE - METHOD VDMAX
    AAMI TIR35 : 2016 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - PRODUCT ADOPTION AND ALTERNATIVE SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS
    AAMI TIR37 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS
    AAMI TIR40 : 2018 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON DOSE SETTING UTILIZING A MODIFIED METHOD 2
    AAMI ST67 : 2011 : R2017 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
    AAMI ST67 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
    AAMI TIR 29 : 2012 : R2017 GUIDE FOR PROCESS CHARACTERIZATION AND CONTROL IN RADIATION STERILIZATION OF MEDICAL DEVICES
    AAMI TIR 29:2012 GUIDE FOR PROCESS CHARACTERIZATION AND CONTROL IN RADIATION STERILIZATION OF MEDICAL DEVICES
    AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
    AAMI TIR17 : 2017 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
    ASTM F 2529 : 2013 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)

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

    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    AAMI ST32 : 1991 GUIDELINE FOR GAMMA RADIATION STERILIZATION
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 11137-3:2017 Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
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