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  • AAMI TIR14 : 2016

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    CONTRACT STERILIZATION USING ETHYLENE OXIDE

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  05-06-2016

    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 Definitions
    3 Selection of sterilization facility
    4 Written agreement between product manufacturer and
      contract sterilizer
    5 Validation program
    6 Handling of BIs, PCDs, and product samples
    7 Sterilization processing documentation
    8 Controls for routine processing
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance that augments ANSI/AAMI/ISO 11135:2014, both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations.

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

    Development Note Formerly it was AAMI ST27 (05/2001)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

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

    AAMI TIR16 : 2017 MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
    AAMI TIR15 : 2016 PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
    AAMI TIR28 : 2016 PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION

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

    AAMI ISO 10993-3 : 2014 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY
    AAMI ISO 11135 : 2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CFR 40(PTS61-71) : JUL 96 PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    AAMI ISO TIR 11139 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY
    AAMI TIR28 : 2016 PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION
    AAMI ISO 11138-2 : 2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES
    AAMI ISO 14161 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS
    CFR 29(PT1910.1000 TO END) : 0 LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
    CFR 40(PTS1-49) : JUL 2017 PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
    AAMI ISO 11138-1 : 2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    AAMI ISO 10993-12 : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
    AAMI ISO 10993-6 : 2016 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
    AAMI ISO 13485 : 2016 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
    AAMI ISO 10993-4 : 2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
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