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    AS ISO 11137-2002

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - Requirements for validation and routine control - Radiation sterilization

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  30-06-2017

    Language(s):  English

    Published date:  01-01-2002

    Publisher:  Standards Australia

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

    1 - AS ISO 11137-2002 Sterilization of health care products - Requirements for validation and routine control - Radiation ster
    4 - PREFACE
    5 - CONTENTS
    7 - INTRODUCTION
    9 - 1 SCOPE
    9 - 2 NORMATIVE REFERENCES
    9 - 3 DEFINITIONS
    12 - 4 DOCUMENTATION
    12 - 5 PERSONNEL
    12 - 6 STERILIZATION PROCESS VALIDATION
    16 - 7 ROUTINE PROCESS CONTROL
    19 - 8 MANAGEMENT AND CONTROL
    20 - ANNEX A DEVICE AND PACKAGING MATERIALS QUALIICICATION
    25 - ANNEX B DOSE SETTING METHODS FOR RADIATION STERILIZATION
    54 - ANNEX C DOSIMETERS, DOSIMETRY AND ASSOCIATED EQUIPMENT
    67 - ANNEX D BIBILOGRAPHY

    Abstract - (Show below) - (Hide below)

    Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products.

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    Committee HE-023
    Document Type Standard
    Publisher Standards Australia
    Status Superseded
    Superseded By
    Supersedes
    Under Revision

    History - (Show below) - (Hide below)

    First published as AS ISO 11137-2002.

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