NF EN ISO 13485/A11

NF EN ISO 13485/A11

September 2021
Standard Current

Medical devices - Quality management systems - Requirements for regulatory purposes

Le présent document modifie la NF EN ISO 13485:2016, avec l'intégration de rectificatifs de mars 2016, décembre 2016 et 2018, avec une révision de l'Avant-propos européen et des Annexes européennes ZA et ZB.

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Main informations

Collections

National standards and national normative documents

Thematics

Management et performance

Publication date

September 2021

Number of pages

29 p.

Reference

NF EN ISO 13485/A11

ICS Codes

03.100.70   Management systems
03.120.10   Quality management and quality assurance
11.040.01   Medical equipment in general

Classification index

S99-101/A11

Print number

1

International kinship

ISO 13485/A11:2021

European kinship

EN ISO 13485/A11:2021
Sumary
Medical devices - Quality management systems - Requirements for regulatory purposes

Le présent document modifie la NF EN ISO 13485:2016, avec l'intégration de rectificatifs de mars 2016, décembre 2016 et 2018, avec une révision de l'Avant-propos européen et des Annexes européennes ZA et ZB.
Table of contents
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  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences concernées du Règlement (UE) 2017/745
  • Annexe ZB (informative) Relation entre la présente Norme européenne et les exigences concernées du Règlement (UE) 2017/746
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