11.040.01: Medical equipment in general
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UNE-EN ISO 10993-7:1996
BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 7: ETHYLENE OXIDE STERILIZATIONN RESIDUALS. (ISO 10993-7:1995).
standard by UNE-EN ISO, 05/23/1996.
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UNE-EN ISO 10993-7:1996 ERRATUM
BIOLOGICAL EVAULATION OF MEDICAL DEVICES. PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS. (ISO 10993-7:1995).
standard by UNE-EN ISO, 06/24/1996.
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- MULTI-USER
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UNE-EN ISO 10993-7:2009
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
standard by UNE-EN ISO, 06/03/2009.
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Corrigenda: UNE-EN ISO 10993-7:2009/AC:2010
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UNE-EN ISO 10993-7:2009/AC:2010
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
Corrigenda by UNE-EN ISO, 02/24/2010.
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- MULTI-USER
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UNE-EN ISO 11197:2005
This document has been replaced. View the most recent version.
Medical supply units. (ISO 11197:2004)
standard by UNE-EN ISO, 07/20/2005.
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Historical Editions: UNE-EN ISO 11197:2009
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UNE-EN ISO 11197:2009
Medical supply units (ISO 11197:2004)
standard by UNE-EN ISO, 09/02/2009.
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Historical Editions: UNE-EN ISO 11197:2005
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UNE-ENV 13004:2000
NOMENCLATURE SYSTEM FOR MEDICAL DEVICES FOR THE PURPOSES OF REGULATORY DATA EXCHANGE. RECOMMENDATIONS FOR AN INTERIM SYSTEM AND RULES FOR A FUTURE SYSTEM.
standard by Asociacion Espanola de Normalizacion y Certificacion (Spanish Standard)/Pre-European Standard, 11/27/2000.
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UNE-EN ISO 13485:2001
This document has been replaced. View the most recent version.
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001. (ISO 13485:1996)
standard by UNE-EN ISO, 07/20/2001.
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Historical Editions: UNE-EN ISO 13485:2004, UNE-EN ISO 13488:2001, UNE-EN 46003:2000
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UNE-EN ISO 13485:2004
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
standard by UNE-EN ISO, 03/12/2004.
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Corrigenda: UNE-EN ISO 13485:2004 ERRATUM:2009, UNE-EN ISO 13485:2004 ERRATUM:2007, UNE-EN ISO 13485:2004 ERRATUM
Historical Editions: UNE-EN ISO 13485:2001, UNE-EN ISO 13488:2001, UNE-EN 46003:2000
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UNE-EN ISO 13485:2004 ERRATUM
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
Corrigenda by UNE-EN ISO, 06/25/2004.
Languages:
- MULTI-USER