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S.R. CEN ISO/TR 20416:2020

Current

Current

The latest, up-to-date edition.

Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-07-2020

Preview

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

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