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  • CSA Z11137-3 : 2007 : R2012 : FR

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-08-2017

    Language(s): 

    Published date:  01-01-2016

    Publisher:  Canadian Standards Association

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Measurement of dose
    5 Selection and calibration of dosimetry systems
    6 Establishing the maximum acceptable dose
    7 Establishing the sterilization dose
    8 Installation qualification
    9 Operational qualification
    10 Performance qualification
    11 Routine monitoring and control
    Annex A (informative) - Mathematical modelling
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides guidance on the requirements in ISO 11137 parts 1 and 2 relating to dosimetry.

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

    Development Note Supersedes CSA ISO 11137. (01/2009)
    Document Type Standard
    Product Note Reconfirmed F
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By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
    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/ASTM 51276:2012 Practice for use of a polymethylmethacrylate dosimetry system
    ISO/ASTM 51261:2013 Practice for calibration of routine dosimetry systems for radiation processing
    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 51607:2013 Practice for use of the alanine-EPR dosimetry system
    ISO 9001:2015 Quality management systems — Requirements
    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
    ASTM E 2303 : 2015 : REDLINE Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
    ISO/ASTM 51631:2013 Practice for use of calorimetric dosimetry systems for electron beam dose measurements and dosimetery system calibrations
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