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  • ANSI/AAMI/ISO 11137-3:2017

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL

    Available format(s):  Hardcopy, PDF

    Superseded date:  08-04-2024

    Language(s):  English

    Published date:  06-10-2017

    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
    Background on the adoption of ISO 11137-3:2017
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms, definitions and symbols
    4 Measurement of dose
    5 Establishing the maximum acceptable dose
    6 Establishing the sterilization dose
    7 Installation qualification
    8 Operational qualification
    9 Performance qualification
    10 Routine monitoring and control
    Annex A (informative) - Mathematical modelling
    Annex B (informative) - Tables of references for
            dosimetry-related testing during IQ/OQ/PQ
    Annex C (informative) - Tolerances associated
            with doses used in sterilization dose
            setting/substantiation in ISO 11137-2
    Annex D (informative) - Application of dose
            measurement uncertainty in setting process
            target doses
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.

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

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    Status Superseded
    Superseded By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

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

    ISO/TS 13004:2013 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    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/ASTM 51401:2013 Practice for use of a dichromate dosimetry system
    ISO/ASTM 51650:2013 Practice for use of a cellulose triacetate dosimetry system
    ISO 11462-2:2010 Guidelines for implementation of statistical process control (SPC) — Part 2: Catalogue of tools and techniques
    ISO/ASTM 51276:2012 Practice for use of a polymethylmethacrylate dosimetry system
    ISO/ASTM 52303:2015 Guide for absorbed-dose mapping in radiation processing facilities
    ISO/ASTM 51818:2013 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
    ISO/ASTM 51261:2013 Practice for calibration of routine dosimetry systems for radiation processing
    ISO 14253-1:2017 Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO/ASTM 51275:2013 Practice for use of a radiochromic film dosimetry system
    ISO/ASTM 51608:2015 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 keV and 7.5 MeV
    ASTM E 2232 : 2016 : REDLINE Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications
    ISO/ASTM 52701:2013 Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    ISO/ASTM 51607:2013 Practice for use of the alanine-EPR dosimetry system
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO/ASTM 51649:2015 Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
    ISO/ASTM 51707:2015 Guide for estimation of measurement uncertainty in dosimetry for radiation processing
    ISO/ASTM 52628:2013 Standard practice for dosimetry in radiation processing
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO/ASTM 51631:2013 Practice for use of calorimetric dosimetry systems for electron beam dose measurements and dosimetery system calibrations
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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