S.R. CEN ISO/TR 20416:2020
Current
The latest, up-to-date edition.
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
Hardcopy , PDF
English
07-09-2020
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Purpose of post-market surveillance process
5 Planning of post-market surveillance
6 Review of the post-market surveillance plan
Annex A (informative) Examples of data sources
Annex B (informative) Examples of data analysis methods
Annex C (informative) Examples of post-market surveillance plans
Bibliography
This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers.
| Committee |
JTC 3
|
| DocumentType |
Standard Recommendation
|
| Pages |
60
|
| ProductNote |
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO :ISO 14155,ISO/IEC 62366-1,GHTF/SG2/N36R7 ,GHTF/SG2/N54R8,GHTF/SG3/N18,GHTF/SG5/N1, GHTF/SG5/N2R8,GHTF/SG5/N4
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| CEN ISO/TR 20416:2020 | Identical |
| ISO/TR 20416:2020 | Identical |
| PD CEN ISO/TR 20416:2020 | Equivalent |
| UNE-CEN ISO/TR 20416:2020 | Equivalent |
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