Your search resulted in 9 documents for "CSA ISO 13485" amongst all current CSA documents.

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  1. MOST RECENT

    1989039

    CSA PLUS 13485 [ Withdrawn ]

    The ISO 13485 Essentials - A Practical Handbook for Implementing the ISO 13485 Standard for Manufacturers of Medical Devices

    Handbook / Manual / Guide by CSA Group, 02/01/2006.

    Languages: English

  2. MOST RECENT

    1929617

    CAN/CSA-ISO 13485:16 (R2021)

    Medical devices - Quality management systems - Requirements for regulatory purposes (Adopted ISO 13485:2016, third edition, 2016-03-01)

    standard by Canada National Standard/Canadian Standards - ISO, 09/01/2016 in English, French.

    Languages: English,French

    Historical Editions: CAN/CSA-ISO 13485-03 (R2013)

  3. CSA 9001MD

    The ISO 9000 and 13485 Essentials - A Practical Handbook for Implementing the ISO 9000 and 13485 Standards for Medical Device Manufacturers

    Handbook / Manual / Guide by CSA Group, 01/01/1998.

    Languages:

  4. MOST RECENT

    945649

    CSA PLUS 9001MD (R2003)

    The ISO 9000 and 13485 Essentials: A Practical Handbook for Implementing the ISO 9000 and 13485 Standards for Medical Device Manufacturers

    Handbook / Manual / Guide by CSA Group, 02/25/2000.

    Languages: English

  5. MOST RECENT

    1506752

    CAN/CSA-ISO/TR 14969-05 (R2015) [ Withdrawn ]

    Medical Devices - Quality Management Systems - Guidance on the Application of ISO 13485:2003 (Adopted ISO/TR 14969:2004, first edition, 2004-10-15)

    standard by Canada National Standard/Canadian Standards - ISO TR, 02/01/2005.

    Languages: English

  6. MOST RECENT

    2232878

    CAN/CSA-ISO/TR 24971:21

    Medical devices - Guidance on the application of ISO 14971

    standard by Canada National Standard/Canadian Standards - ISO TR, 08/01/2021 in French, English.

    Languages: English,French

  7. MOST RECENT

    2075978

    CAN/CSA-ISO 20857:19

    Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

    standard by Canada National Standard/Canadian Standards - ISO, 06/01/2019 in English, French.

    Languages: English,French

  8. MOST RECENT

    1818108

    CAN/CSA-ISO 14937:11 (R2021)

    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 (Adopted ISO 14937:2009, second edition, 2009-10-15)

    standard by Canada National Standard/Canadian Standards - ISO, 10/01/2011 in English, French.

    Languages: English,French

    Historical Editions: CAN/CSA-ISO 14937-01 (R2011)

  9. MOST RECENT

    1906340

    CAN/CSA Z11135:15 (R2020)

    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 11135:2014, second edition, 2014-07-15)

    standard by Canadian Standards Association / National Standard of Canada, 11/01/2015 in English, French.

    Languages: English,French

    Historical Editions: CAN/CSA Z11135-1-09 (R2014)CAN/CSA Z11135-2-09 (R2014)CAN/CSA-ISO 11135-98 (R2003)