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  • CSA Z314.0 : 2013

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL DEVICE REPROCESSING - GENERAL REQUIREMENTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  23-09-2021

    Language(s):  English, French

    Published date:  01-01-2013

    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 Quality management system (QMS)
    5 Evaluation and purchase of reusable medical devices
       and reprocessing equipment
    6 Personnel
    7 Work areas and design
    8 Reprocessing principles
    9 Process verification, monitoring, and adverse events
    10 Storage
    Annex A (informative) - Micro-organisms and infection
    Annex B (informative) - Guidance for the design of medical
            device reprocessing areas
    Annex C (informative) - Additional sterile storage
            considerations
    Annex D (informative) - Risk management and sterility
            assurance
    Annex E (informative) - Water quality
    Annex F (informative) - Sample forms and tools for MDRDs

    Abstract - (Show below) - (Hide below)

    Pertains to form the basis of a QMS within a health care setting for the purpose of providing safe, reliable reprocessing of reusable medical devices and is designed to be used with the CSA Z314 series of Standards addressing specific aspects of medical device reprocessing.

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

    Development Note French Edition issued on 01-11-2014. (12/2014)
    Document Type Standard
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By

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

    CSA SPE 1112 : 2014 MEDICAL DEVICE REPROCESSING IN COMMUNITY HEALTH CARE SETTINGS
    CSA Z314.22 : 2016 MANAGEMENT OF LOANED, REUSABLE MEDICAL DEVICES
    CSA Z11135 : 2015 STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    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
    CSA Z314.15 : 2015 STORAGE, TRANSPORTATION, AND DISTRIBUTION OF SINGLE USE AND REUSABLE MEDICAL DEVICES
    CSA Z314.23 : 2016 CHEMICAL STERILIZATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE SETTINGS
    CSA Z314.14 : 2015 SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS
    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 Z317.2 : 2010 SPECIAL REQUIREMENTS FOR HEATING, VENTILATION, AND AIR-CONDITIONING (HVAC) SYSTEMS IN HEALTH CARE FACILITIES

    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 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
    AAMI TIR34 : 2014 WATER FOR THE REPROCESSING OF MEDICAL DEVICES
    CSA Z314.7 : 2003(R2018) STEAM STERILIZERS FOR HEALTH CARE FACILITIES
    CAN/CSA-ISO 13485:16 Medical devices - Quality management systems - Requirements for regulatory purposes (Adopted ISO 13485:2016, third edition, 2016-03-01)
    CSA Z314.14 : 2015 SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS
    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
    CSA ISO 9001 : 2016 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    CSA Z314.23 : 2016 CHEMICAL STERILIZATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE SETTINGS
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