11.040.01: Medical equipment in general
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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 13485 AND 14969 PACKAGE, ISO/TR 14969:2004, ISO 13485:2003
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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 13485 AND 14969 PACKAGE, ISO/TR 14969:2004, ISO 13485:1996
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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 13485 AND 14969 PACKAGE, ISO/TR 14969:2004, ISO 13485:2003, ISO 13485:1996
- Redlines
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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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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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ISO 13488:1996 [ Withdrawn ]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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ISO/TR 14969:2004 [ Withdrawn ]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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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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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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ISO 14971:2019
Medical devices - Application of risk management to medical devices
standard by International Organization for Standardization, 12/01/2019 in Spanish, English, French.
Languages: English,French,Spanish
Historical Editions: ISO 14971:2019 Plus Redline, ISO 14971:2007, ISO 14971/Amd1:2003, ISO 14971:2000
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