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  • CSA ISO 11137 : 1998

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-10-2008

    Language(s):  French

    Published date:  01-01-2003

    Publisher:  Canadian Standards Association

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

    1 Scope
    2 Normative references
    3 Definitions
    4 Documentation
    5 Personnel
    6 Sterilization process validation
       6.1 General
       6.2 Product qualification
       6.3 Installation qualification
       6.4 Process qualification
       6.5 Certification
       6.6 Maintenance of validation
    7 Routine process control
       7.1 process specification
       7.2 Product handling
       7.3 Routine and preventive maintenance
       7.4 Product irradiation
       7.5 Process documentation
       7.6 Sterilization acceptance
    8 Management and control
    Annexes
    A Device and packaging materials qualification
    B Dose setting methods for radiation sterilization
    C Dosimeters, dosimetry and associated equipment
    D Bibliography

    Abstract - (Show below) - (Hide below)

    Gives requirements for process control, validation and routine monitoring in the radiation sterilization of health care products.

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

    Document Type Standard
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By
    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 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

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

    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
    ISO 9001:2015 Quality management systems — Requirements
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