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  • CSA ISO 11135 : 1998:R2003

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-03-2009

    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 General
       4.1 Personnel
       4.2 Process development and product compatibility
       4.3 Sterilization process
       4.4 Equipment
       4.5 Calibration
       4.6 Maintenance
    5 Validation
       5.1 General
       5.2 Commissioning
       5.3 Performance qualification - physical
       5.4 Performance qualification - microbiological
       5.5 Certification of validation
       5.6 Revalidation
    6 Process control and monitoring
    7 Product release
       7.1 Conventional product release
       7.2 Parametric release
    Annexes
    A General aspects of sterilization
    B Validation
    C Process control and monitoring [6]
    D Product release [7]

    Abstract - (Show below) - (Hide below)

    Specifies guidance and requirements for routine control and validation of ethylene oxide sterilization processes for medical devices.

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

    Development Note Supersedes CSA Z314.5 (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    Status Superseded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
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 9001:2015 Quality management systems — Requirements
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
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