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  • AAMI TIR37 : 2013

    Current The latest, up-to-date edition.

    STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-12-2013

    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
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Definition and maintenance of product
      families for dose setting, dose substantiation
      and sterilization dose auditing
    5 Selection and testing of product for establishing
      and verifying the sterilization dose
    6 Methods of dose establishment
    Annex A (informative) - Selection of a Dose
            Setting Method
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance for development, validation and routine control associated with the radiation sterilization processing of biologics and tissue-based products.

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

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    14/30266295 DC : 0 BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS
    ISO 11737-1:2018 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
    ISO 18362:2016 Manufacture of cell-based health care products Control of microbial risks during processing
    I.S. EN ISO 11737-1:2018&LC:2018 STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS (ISO 11737-1:2018)
    BS ISO 18362:2016 Manufacture of cell-based health care products. Control of microbial risks during processing

    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 51261:2013 Practice for calibration of routine dosimetry systems for radiation processing
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    AAMI TIR35 : 2016 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - PRODUCT ADOPTION AND ALTERNATIVE SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS
    AAMI ISO TIR 11139 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY
    AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
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