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  • AAMI TIR30:2011(R2016)

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  13-02-2024

    Language(s):  English

    Published date:  15-12-2016

    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
    Acknowledgments
    Foreword
    Introduction
    1 Scope
    2 Definitions, abbreviations, and symbols
    3 Device materials
    4 Device design
    5 Cleaning processes available in health
      care facilities
    6 Test soils
    7 Test methods, equipment, and acceptance
      criteria
    8 Regulatory considerations
    Annexes
    A - Cleaning validation protocol
    B - Determining surface area and volume of
        a channel
    C - Bibliography

    Abstract - (Show below) - (Hide below)

    Provides information regarding test protocols, materials, test soils, and acceptance criteria that can be used by medical device manufacturers to validate cleaning processes for reusable medical devices.

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

    Document Type Standard
    Product Note Reconfirmed 2016
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    ANSI/AAMI/ISO 17664-1:2022 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
    ANSI/AAMI/ISO 17664-2:2022 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices

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

    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    EN ISO 14729:2001/A1:2010 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses - Amendment 1 (ISO 14729:2001/Amd 1:2010)
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organisations
    AAMI TIR34 : 2014 WATER FOR THE REPROCESSING OF MEDICAL DEVICES
    ISO 15883-3:2006 Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
    AS 2945-1998 Batch-type washer/disinfectors for health care facilities
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    AAMI RD47 : 2008 REPROCESSING OF HEMODIALYZERS
    BS 2745-2:1993 Washer-disinfectors for medical purposes Specification for human waste container washer-disinfectors
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
    AS 3836-1998 Rack conveyor washers for health care facilities
    ISO 14729:2001 Ophthalmic optics — Contact lens care products — Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    AS 2773-1985 Ultrasonic cleaners for hospital use
    ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
    AAMI ST15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
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