CEN/TR 17223:2018
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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
04-10-2023
21-03-2018
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Withdrawn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 |
| UNI CEN/TR 17223:2018 | Identical |
| 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 |
| PNE-FprCEN/TR 17223 | Identical |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.