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  • AAMI TIR 29:2012(R2017)

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    GUIDE FOR PROCESS CHARACTERIZATION AND CONTROL IN RADIATION STERILIZATION OF MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-03-2024

    Language(s):  English

    Published date:  18-10-2017

    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
    Foreword
    1 Scope
    2 Normative reference
    3 Terms and definitions
    4 Installation qualification
    5 Operational Qualification
    6 Performance Qualification
    7 Product and Process Specifications
    8 Routine Monitoring and Control
    9 Maintaining Process Effectiveness
    10 Assessment of Change
    Annexes
    Annex A - Measurement uncertainty in
              routine monitoring of dose
    Annex B - Source distribution equivalency
    Annex C (informative) - Bibliography

    Abstract - (Show below) - (Hide below)

    Gives additional guidance for establishing and meeting the irradiator Operational Qualification (OQ), Performance Qualification (PQ), and routine control requirements for radiation sterilization as defined in ANSI/AAMI/ISO 11137-1 for gamma, electron beam, and X-ray sterilization.

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

    Document Type Guide
    Product Note Reconfirmed 2017
    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    Status Superseded
    Superseded By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
    ISO/ASTM 51702:2013 Practice for dosimetry in a gamma facility for radiation processing
    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/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 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/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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