11.040.01: Medical equipment in general
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UNE-EN ISO 13485:2004 ERRATUM:2007
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
Corrigenda by UNE-EN ISO, 10/31/2007.
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- MULTI-USER
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UNE-EN ISO 13485:2004 ERRATUM:2009
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
Corrigenda by UNE-EN ISO, 10/21/2009.
Languages:
- MULTI-USER
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HISTORICAL
UNE-EN ISO 13488:2001
This document has been replaced. View the most recent version.
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002. (ISO 13488:1996)
standard by UNE-EN ISO, 07/13/2001.
Languages:
Historical Editions: UNE-EN ISO 13485:2004, UNE-EN ISO 13485:2001, UNE-EN 46003:2000
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HISTORICAL
UNE-EN 13718-1:2003
This document has been replaced. View the most recent version.
Air, water and difficult terrain ambulances. Part 1: Medical device interface requirements for the continuity of patient care.
standard by UNE-EN, 01/24/2003.
Languages:
Historical Editions: UNE-EN 13718-1:2009
- MULTI-USER
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UNE-EN 13718-1:2009
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
standard by UNE-EN, 02/18/2009.
Languages:
Historical Editions: UNE-EN 13718-1:2003
- MULTI-USER
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HISTORICAL
UNE-EN 13718-2:2003
This document has been replaced. View the most recent version.
Air, water and difficult terrain ambulances. Part 2: Operational and technical requirements for the continuity of patient care.
standard by UNE-EN, 01/24/2003.
Languages:
Historical Editions: UNE-EN 13718-2:2009
- MULTI-USER
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UNE-EN 13718-2:2009
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements of air ambulances.
standard by UNE-EN, 03/11/2009.
Languages:
Historical Editions: UNE-EN 13718-2:2003
- MULTI-USER
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UNE-CR 14060:2001
Medical device traceability.
standard by UNE-CR, 10/30/2001.
Languages:
- MULTI-USER
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HISTORICAL
UNE-EN ISO 14155-2:2004
This document has been replaced. View the most recent version.
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
standard by UNE-EN ISO, 01/23/2004.
Languages:
Historical Editions: UNE-EN ISO 14155:2012, UNE-EN ISO 14155-2:2009, UNE-EN ISO 14155-1:2009, UNE-EN ISO 14155-1:2003 ERRATUM:2005, UNE-EN ISO 14155-1:2003
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HISTORICAL
UNE-EN ISO 14155-2:2009
This document has been replaced. View the most recent version.
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
standard by UNE-EN ISO, 12/09/2009.
Languages:
Historical Editions: UNE-EN ISO 14155:2012, UNE-EN ISO 14155-1:2009, UNE-EN ISO 14155-1:2003 ERRATUM:2005, UNE-EN ISO 14155-2:2004, UNE-EN ISO 14155-1:2003
- MULTI-USER
