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  • AAMI TIR34 : 2014

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    WATER FOR THE REPROCESSING OF MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  25-01-2020

    Language(s):  English

    Published date:  01-01-2014

    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 Definitions and abbreviations
    3 The importance of water quality
       and effective water treatment
    4 Categories of water quality for
       medical device reprocessing
    5 Selection of water quality
    6 Water treatment systems
    7 Monitoring water quality
    8 Strategies for bacterial control
    9 Personnel considerations
    10 Continuous quality improvement
    Annexes
    Annex A (informative) - Water treatment methods
    Annex B (informative) - Monitoring water treatment equipment
            and processes
    Annex C (informative) - Water storage and distribution
    Annex D (informative) - Strategies for bacterial control
    Annex E (informative) - Thermal disinfection
    Annex F (informative) - water treatment using filtration
    Annex G (informative) - Typical presentation of water quality
            issues during the reprocessing of medical devices
    Annex H - Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the water quality needs for reprocessing various categories of medical devices at various stages of reprocessing and how to assess, generate, monitor, and maintain water meeting those requirements.

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

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    Status Superseded
    Superseded By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

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

    AAMI ST91 : 2015 FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES
    AAMI TIR16 : 2017 MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
    AAMI ST58 : 2013(R2018) CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
    CSA Z317.1 : 2016 SPECIAL REQUIREMENTS FOR PLUMBING INSTALLATIONS IN HEALTH CARE FACILITIES
    CSA Z314.3 : 2009 EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS
    CSA Z314.3 : 2009 : R2014 EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS
    CSA Z314.8 : 2014 DECONTAMINATION OF REUSABLE MEDICAL DEVICES
    CAN/CSA-Z314-18 Canadian medical device reprocessing
    AAMI ST55 : 2016 TABLE-TOP STEAM STERILIZERS
    AAMI ST8 : 2013(R2018) HOSPITAL STEAM STERILIZERS
    AAMI TIR58 : 2014 WATER TESTING METHODOLOGIES
    AAMI TIR30 : 2011 A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
    AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
    CSA Z314.0 : 2013 MEDICAL DEVICE REPROCESSING - GENERAL REQUIREMENTS
    AAMI TIR30 : 2011 : R2016 A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
    CSA Z317.2 : 2010 SPECIAL REQUIREMENTS FOR HEATING, VENTILATION, AND AIR-CONDITIONING (HVAC) SYSTEMS IN HEALTH CARE FACILITIES
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES

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

    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    CSA Z314.8 : 2014 DECONTAMINATION OF REUSABLE MEDICAL DEVICES
    ASTM F 1518 : 2000 Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera (Withdrawn 2009)
    ISO 15883-3:2006 Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
    AAMI ISO 26722 : 2009 WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS APPLICATIONS AND RELATED THERAPIES
    AAMI ST15883-3 : 2012 WASHER-DISINFECTORS - PART 3: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR HUMAN WASTE CONTAINERS
    AAMI ST55 : 2016 TABLE-TOP STEAM STERILIZERS
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    AAMI ISO 11663 : 2009 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES
    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
    AAMI ISO 13959 : 2009 WATER FOR HEMODIALYSIS AND RELATED THERAPIES
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    AAMI ST15883-2 : 2013 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    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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