11.040.01: Medical equipment in general

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  1. HISTORICAL

    ISO 13485:1996▹

    This document has been replaced. View the most recent version.

    Quality systems - Medical devices - Particular requirements for the application of ISO 9001

    standard by International Organization for Standardization, 12/01/1996.

    Languages: English

    Historical Editions: ISO 13485:2016 Plus Redline, ISO 13485:2016, ISO/TR 14969:2004, ISO 13485 AND 14969 PACKAGE, ISO 13485:2003

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  2. HISTORICAL

    ISO 13485:2003▹

    This document has been replaced. View the most recent version.

    Medical devices - Quality management systems - Requirements for regulatory purposes

    standard by International Organization for Standardization, 07/15/2003.

    Languages: English

    Corrigenda: ISO 13485/Cor1:2009

    Historical Editions: ISO 13485:2016 Plus Redline, ISO 13485:2016, ISO/TR 14969:2004, ISO 13485 AND 14969 PACKAGE, ISO 13485:1996

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  3. MOST RECENT

    ISO 13485:2016▹

    Medical devices - Quality management systems - Requirements for regulatory purposes

    standard by International Organization for Standardization, 03/01/2016.

    Languages: English

    Historical Editions: ISO 13485:2016 Plus Redline, ISO/TR 14969:2004, ISO 13485 AND 14969 PACKAGE, ISO 13485:2003, ISO 13485:1996

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  4. HISTORICAL

    ISO 13485 AND 14969 PACKAGE▹

    This document has been replaced. View the most recent version.

    ISO 13485:2003 and ISO/TR 14969:2004 Quality Managment Systems Medical Devices Package

    standard by International Organization for Standardization, 10/15/2004.

    Languages:

    Historical Editions: ISO 13485:2016 Plus Redline, ISO 13485:2016, ISO/TR 14969:2004, ISO 13485:2003, ISO 13485:1996

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  5. MOST RECENT

    ISO 13485/Cor1:2009▹

    Medical devices - Quality management systems - Requirements for regulatory purposes - Corrigendum 1

    Corrigenda by International Organization for Standardization, 08/01/2009.

    Languages: English

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  6. MOST RECENT

    ISO 13488:1996▹ [ Withdrawn ]

    Quality systems - Medical devices - Particular requirements for the application of ISO 9002

    standard by International Organization for Standardization, 12/01/1996.

    Languages: English

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  7. HISTORICAL

    ISO/TR 14969:2004▹ [ Withdrawn ]

    This document has been replaced. View the most recent version.

    Medical devices - Quality mangement systems - Guidance on the application of ISO 13485:2003

    standard by International Organization for Standardization (Technical Report), 10/15/2004.

    Languages: English

    Historical Editions: ISO 13485:2016 Plus Redline, ISO 13485:2016, ISO 13485 AND 14969 PACKAGE, ISO 13485:2003, ISO 13485:1996

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  8. HISTORICAL

    ISO 14971:2000▹

    This document has been replaced. View the most recent version.

    Medical devices -- Application of risk management to medical devices

    standard by International Organization for Standardization, 12/15/2000.

    Languages: English

    Amendments, rulings, and supplements: ISO 14971/Amd1:2003

    Historical Editions: ISO 14971:2019 Plus Redline, ISO 14971:2019, ISO 14971:2007, ISO 14971/Amd1:2003

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  9. HISTORICAL

    ISO 14971:2007▹

    This document has been replaced. View the most recent version.

    Medical devices - Application of risk management to medical devices

    standard by International Organization for Standardization, 10/01/2007.

    Languages: English

    Historical Editions: ISO 14971:2019 Plus Redline, ISO 14971:2019, ISO 14971/Amd1:2003, ISO 14971:2000

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  10. MOST RECENT

    ISO 14971:2019▹

    Medical devices - Application of risk management to medical devices

    standard by International Organization for Standardization, 12/01/2019 in Spanish, English.

    Languages: English,Spanish

    Historical Editions: ISO 14971:2019 Plus Redline, ISO 14971:2007, ISO 14971/Amd1:2003, ISO 14971:2000

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