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    I.S. EN ISO 11137-3:2017

    Current The latest, up-to-date edition.

    STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    European foreword
    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 and ISO/TS 13004
    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 I.S. EN 552. (07/2006)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    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/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
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