CEN/TR 17223:2018
Withdrawn
Withdrawn
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
Published date
03-21-2018
Publisher
Withdrawn date
10-04-2023
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European Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Relationship between the European Regulations
for Medical Devices and in vitro Diagnostic
Medical Devices and the clauses of EN ISO 13485
This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.
| Committee |
CEN/CLC/JTC 3
|
| DocumentType |
Technical Report
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| FD CEN/TR 17223 : 2018 | Identical |
| PD CEN/TR 17223:2018 | Identical |
| SIS-CEN/TR 17223 : 2018 | Identical |
| CEI CEN/TR 17223 : 2019 | Identical |
| NEN NPR CEN/TR 17223 : 2018 | Identical |
| S.R. CEN/TR 17223:2018 | Identical |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
Summarise
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