UNE-EN ISO 13485:2018/A11:2022
Active Standard amendment
Most Recent

UNE-EN ISO 13485:2018/A11:2022

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Base standard
No description.

Technical characteristics

Publisher Asociacion Espanola de Normalizacion y Certificacion (AENOR)
Publication Date 09/21/2022
Page Count 30
EAN ---
ISBN ---
Weight (in grams) ---

modifies

Previous versions

UNE-EN ISO 13485:2018/A11:2022

UNE-EN ISO 13485:2018/A11:2022

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
21/09/2022
Active
Most Recent
UNE-EN ISO 13485:2018

UNE-EN ISO 13485:2018

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
25/07/2018
Active , Modified
Most Recent
UNE-EN ISO 13485:2016/AC:2017

UNE-EN ISO 13485:2016/AC:2017

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
12/04/2017
Superseded
Historical
UNE-EN ISO 13485:2016

UNE-EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
25/05/2016
Superseded
Historical
UNE-EN ISO 13485:2013

UNE-EN ISO 13485:2013

Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)
29/05/2013
Superseded
Historical
UNE-EN ISO 13485:2012

UNE-EN ISO 13485:2012

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
23/05/2012
Superseded
Historical
UNE-EN ISO 13485:2004 ERRATUM:2009

UNE-EN ISO 13485:2004 ERRATUM:2009

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
21/10/2009
Superseded
Historical
UNE-EN ISO 13485:2004 ERRATUM:2007

UNE-EN ISO 13485:2004 ERRATUM:2007

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
31/10/2007
Superseded
Historical
UNE-EN ISO 13485:2004 ERRATUM

UNE-EN ISO 13485:2004 ERRATUM

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
25/06/2004
Superseded
Historical
UNE-EN ISO 13485:2004

UNE-EN ISO 13485:2004

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
12/03/2004
Superseded
Historical
UNE-EN ISO 13485:2001

UNE-EN ISO 13485:2001

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001. (ISO 13485:1996)
20/07/2001
Superseded
Historical
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