FD CEN/TR 17223

FD CEN/TR 17223

November 2018
Published document Cancelled

Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

Le présent document fournit des recommandations relatives à la relation entre la NF EN ISO 13485:2016 (Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires) et les exigences présentées dans le Règlement (UE) 2017/745 relatif aux dispositifs médicaux et au Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro.

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Main informations

Collections

National standards and national normative documents

Thematics

Management et performance

Publication date

November 2018

Number of pages

89 p.

Reference

FD CEN/TR 17223

ICS Codes

03.100.70   Management systems
03.120.10   Quality management and quality assurance
11.040.01   Medical equipment in general
11.100.10   In vitro diagnostic test systems

Classification index

S99-212

Print number

1

European kinship

CEN/TR 17223:2018
Sumary
Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

Le présent document fournit des recommandations relatives à la relation entre la NF EN ISO 13485:2016 (Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires) et les exigences présentées dans le Règlement (UE) 2017/745 relatif aux dispositifs médicaux et au Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro.
Table of contents
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  • Avant-propos européen
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Relation entre les Règlements européens relatifs aux dispositifs médicaux et aux dispositifs médicaux de diagnostic in vitro et les articles de l'EN ISO
    13485
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