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  • CSA ISO TR 14969 : 2005 : R2015

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  19-06-2020

    Language(s):  English

    Published date:  01-01-2015

    Publisher:  Canadian Standards Association

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality management system
    5 Management responsibility
    6 Resource management
    7 Product realization
    8 Measurement, analysis and improvement
    Annex A (informative) - Terms used in certain regulatory
            administrations to describe documents referenced in
            this Technical Report
    Annex B (informative) - Analysis of significant changes from
            ISO 13485:1996 to ISO 13485:2003
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance for the application of the requirements for quality management systems contained in ISO 13485.

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

    Document Type Standard
    Product Note Reconfirmed EN
    Publisher Canadian Standards Association
    Status Withdrawn
    Supersedes

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

    ISO 19011:2011 Guidelines for auditing management systems
    ISO 14644-6:2007 Cleanrooms and associated controlled environments Part 6: Vocabulary
    ISO 14644-8:2013 Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC)
    ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
    ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 14644-2:2015 Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14644-5:2004 Cleanrooms and associated controlled environments — Part 5: Operations
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    EN 724 : 1994 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    ISO 10005:2005 Quality management systems Guidelines for quality plans
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    ISO/TS 13409:2002 Sterilization of health care products Radiation sterilization Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO/TR 10013:2001 Guidelines for quality management system documentation
    ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    EN 50103 : 1995 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 9001:2015 Quality management systems — Requirements
    EN 928 : 1995 IN VITRO DIAGNOSTIC SYSTEMS - GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    ISO 10007:2017 Quality management — Guidelines for configuration management
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 13683:1997 Sterilization of health care products Requirements for validation and routine control of moist heat sterilization in health care facilities
    ISO 12891-1:2015 Retrieval and analysis of surgical implants Part 1: Retrieval and handling
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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