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  • CSA Z314.3 : 2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS

    Available format(s):  Hardcopy, PDF

    Superseded date:  09-10-2020

    Language(s):  English, French

    Published date:  01-01-2009

    Publisher:  Canadian Standards Association

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

    Preface
    0 Introduction
    1 Scope
    2 Reference publications
    3 Definitions
    4 Utilities
    5 Preparing medical devices and packages for steam sterilization
    6 Packaging
    7 Sterilizer loading and operation
    8 Sterility assurance
    9 Immediate use steam sterilization (IUSS)
    Annex A (informative) - Examples for performance qualification of
            products and loads
    Annex B (informative) - Tools and indicators for sterilization
            monitoring
    Annex C (informative) - Specifications and calculations for the
            density of muslin textile packages
    Annex D (informative) - Steam quality
    Annex E (informative) - In-house prepared PCDs
    Annex F (informative) - Moisture assessment
    Annex G (informative) - Relevant standards

    Abstract - (Show below) - (Hide below)

    Defines essential elements for using steam to sterilize medical devices in health care settings, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to health care setting personnel and patients.

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

    Development Note Supersedes and renumbers CSA CAN3 Z314.3. (07/2004) Supersedes CSA Z314.13. (05/2010) To be read in conjunction with CSA Z314.0. (09/2014) French Edition issued on 01-03-2015. (05/2015)
    Document Type Standard
    Product Note Reconfirmed EN
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By
    Supersedes

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

    CSA Z314.10.1 : 2015 SELECTION AND USE OF GOWNS AND DRAPES INTENDED FOR USE IN HEALTH CARE SETTINGS
    CSA Z314.10.2 : 2015 LAUNDERING, MAINTENANCE, AND PREPARATION OF REUSABLE GOWNS, DRAPES, AND WRAPPERS FOR HEALTH CARE SETTINGS AND LAUNDRIES
    ISO/TS 17665-3:2013 Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
    CSA SPE 1112 : 2014 MEDICAL DEVICE REPROCESSING IN COMMUNITY HEALTH CARE SETTINGS
    CSA Z317.2 : 2010 SPECIAL REQUIREMENTS FOR HEATING, VENTILATION, AND AIR-CONDITIONING (HVAC) SYSTEMS IN HEALTH CARE FACILITIES
    CSA Z314.8 : 2014 DECONTAMINATION OF REUSABLE MEDICAL DEVICES
    BS EN 285:2015 Sterilization. Steam sterilizers. Large sterilizers
    AAMI TIR34 : 2014 WATER FOR THE REPROCESSING OF MEDICAL DEVICES
    CSA Z314.7 : 2003(R2018) STEAM STERILIZERS FOR HEALTH CARE FACILITIES
    CSA Z314.0 : 2013 MEDICAL DEVICE REPROCESSING - GENERAL REQUIREMENTS
    CSA Z314.14 : 2015 SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS
    AAMI TIR31 : 2008 PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES
    CSA Z314.22 : 2016 MANAGEMENT OF LOANED, REUSABLE MEDICAL DEVICES
    CSA Z314.15 : 2015 STORAGE, TRANSPORTATION, AND DISTRIBUTION OF SINGLE USE AND REUSABLE MEDICAL DEVICES
    ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    CSA Z32 : 2015 ELECTRICAL SAFETY AND ESSENTIAL ELECTRICAL SYSTEMS IN HEALTH CARE FACILITIES
    ISO 11138-5:2017 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    CSA Z314.23 : 2016 CHEMICAL STERILIZATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE SETTINGS
    C282-15 Emergency electrical power supply for buildings
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