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    S.R. CEN ISO/TS 13004:2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - SUBSTANTIATION OF SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD] (ISO/TS 13004:2013)

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-06-2023

    Language(s):  English

    Published date:  01-01-2014

    Publisher:  National Standards Authority of Ireland

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Definition and maintenance of product families for
      sterilization dose substantiation and sterilization
      dose auditing
    5 Selection and testing of product for substantiating and
      auditing a selected sterilization dose
    6 Method VD[MAX][SD] - Substantiation of a selected
      sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5,
      or 35 kGy
    7 Maintaining process effectiveness
    8 Tables of values for SIP equal to 1,0 VD[max][SD], SIP
      dose reduction factor and augmentation dose corresponding
      to applicable values of average bioburden for selected
      sterilization doses of 17,5, 20, 22,5, 27,5, 30, 32,5
      and 35 kGy
    9 Worked examples
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10[-6] or less for radiation sterilization of health care products.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    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 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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