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  • CSA ISO 11134 : 0

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - INDUSTRIAL MOIST HEAT STERILIZATION

    Available format(s):  Hardcopy, PDF

    Superseded date:  23-07-2013

    Language(s):  English

    Published date: 

    Publisher:  Canadian Standards Association

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

    1 Scope
    2 Normative references
    3 Definitions
    4 General
    5 Equipment
    6 Sterilization process development
    7 Sterilization process validation
    8 Routine moist heat sterilization
    Annexes
    A Guidance for validation and routine control of
       industrial moist heat sterilization
    B Sterilization cycles
    C Bibliography

    Abstract - (Show below) - (Hide below)

    Gives requirements for using moist heat in sterilization process development, validation of the sterilization process and the routine control of sterilization.

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

    Development Note Supersedes CSA Z314.4 (06/2006)
    Document Type Standard
    Publisher Canadian Standards Association
    Status Superseded
    Supersedes

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

    CSA Z10651-5 : 2008 : R2013 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
    CSA Z10651-5 : 2008 : INC : UPD 1 : 2011 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
    CSA Z8638 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
    CSA Z10651-5 : 2008 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
    CSA Z10651-5 : 2008 : R2018 Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators
    CSA Z8637 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS

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

    ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
    IEC 61010-2-041:1995 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-041: Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes
    ISO 9001:2015 Quality management systems — Requirements
    ISO 9003:1994 Quality systems Model for quality assurance in final inspection and test
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
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