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  • CSA Z314.14 : 2015

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  19-07-2021

    Language(s):  English, French

    Published date:  01-01-2015

    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 General requirements for all packaging systems
    5 Pouches and rolls
    6 Wrappers
    7 Sterilization trays and container systems
    Annex A (informative) - Guidance for the purchase of
            sterilization container systems
    Annex B (normative) - Information to be supplied by the
            manufacturer
    Annex C (informative) - Properties of sterilization wrappers

    Abstract - (Show below) - (Hide below)

    Specifies essential elements for the evaluation, selection, inspection, and proper use of preformed sterile barrier systems, sterile barrier systems, and packaging systems.

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

    Development Note French Edition issued on 01-01-2016. (02/2016)
    Document Type Standard
    Publisher Canadian Standards Association
    Status Withdrawn
    Supersedes

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

    CSA PLUS 1112 : 2004 INFECTION PREVENTION AND CONTROL IN OFFICE-BASED HEALTH CARE AND ALLIED SERVICES
    CSA Z314.1:2009 ETHYLENE OXIDE STERILIZERS FOR HEALTH CARE FACILITIES
    CSA Z314.3 : 2009 : R2014 EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS
    CSA Z314.23 : 2016 CHEMICAL STERILIZATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE SETTINGS
    CSA Z314.10.1 : 2015 SELECTION AND USE OF GOWNS AND DRAPES INTENDED FOR USE IN HEALTH CARE SETTINGS
    AAMI ST77 : 2013 CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    CSA Z314.22 : 2016 MANAGEMENT OF LOANED, REUSABLE MEDICAL DEVICES
    CSA Z314.9 : 2009 INSTALLATION, VENTILATION, AND SAFE USE OF ETHYLENE OXIDE STERILIZERS IN HEALTH CARE FACILITIES
    CSA Z314.3 : 2009 EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS
    CSA Z314.10.2 : 2015 LAUNDERING, MAINTENANCE, AND PREPARATION OF REUSABLE GOWNS, DRAPES, AND WRAPPERS FOR HEALTH CARE SETTINGS AND LAUNDRIES
    CSA Z8000 : 2011 : R2016 CANADIAN HEALTH CARE FACILITIES
    CSA Z8000 : 2011 CANADIAN HEALTH CARE FACILITIES
    CSA Z8000 : 2011 : INC : UPD 1 : 2013 CANADIAN HEALTH CARE FACILITIES
    CSA Z314.9 : 2009 : R2013 INSTALLATION, VENTILATION, AND SAFE USE OF ETHYLENE OXIDE STERILIZERS IN HEALTH CARE FACILITIES
    CSA Z314.2 : 2009 EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE ETHYLENE OXIDE PROCESS
    CSA Z314.1 : 2009 : R2013 ETHYLENE OXIDE STERILIZERS FOR HEALTH CARE FACILITIES
    CSA Z314.0 : 2013 MEDICAL DEVICE REPROCESSING - GENERAL REQUIREMENTS

    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
    CSA Z314.8 : 2014 DECONTAMINATION OF REUSABLE MEDICAL DEVICES
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    NFPA 701 : 2015 FIRE TESTS FOR FLAME PROPAGATION OF TEXTILES AND FILMS
    CSA Z314.0 : 2013 MEDICAL DEVICE REPROCESSING - GENERAL REQUIREMENTS
    DIN 58953-6:2016-12 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
    ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
    CFR 16(PTS1000-END) : 0 COMMERCIAL PRACTICES - FEDERAL TRADE COMMISSION - CONSUMER PRODUCT SAFETY COMMISSION
    CSA Z314.22 : 2016 MANAGEMENT OF LOANED, REUSABLE MEDICAL DEVICES
    ASTM F 1608 : 2016 : REDLINE Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
    ISO 22610:2006 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Test method to determine the resistance to wet bacterial penetration
    EN 13795:2011+A1:2013 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
    ASTM F 2101 : 2014 : REDLINE TEST METHOD FOR EVALUATING THE BACTERIAL FILTRATION EFFICIENCY (BFE) OF MEDICAL FACE MASK MATERIALS, USING A BIOLOGICAL AEROSOL OF STAPHYLOCOCCUS AUREUS
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    CGSB 4.162 : M80 HOSPITAL TEXTILES - FLAMMABILITY PERFORMANCE REQUIREMENTS
    CSA Z314.23 : 2016 CHEMICAL STERILIZATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE SETTINGS
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