I.S. EN 13612:2002
Current
The latest, up-to-date edition.
PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
Hardcopy , PDF
English
01-01-2002
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Foreword
Introduction
1 Scope
2 Terms and definitions
3 General requirements for the performance evaluation
3.1 Responsibilities and resources
3.2 Documentation
3.3 Final assessment and review
4 Organisation of a performance evaluation study
4.1 Preconditions
4.2 Evaluation plan
4.3 Sites and resources
4.4 Basic design information
4.5 Experimental design
4.6 Performance study records
4.7 Observations and unexpected outcomes
4.8 Evaluation report
5 Modifications during the performance evaluation study
6 Re-evaluation
7 Protection and safety of probands
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other
provisions of EU Directives
Bibliography
Applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer.
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| UNE-EN 13612:2002 | Identical |
| UNI EN 13612 : 2002 | Identical |
| DIN EN 13612:2002-08 | Identical |
| BS EN 13612:2002 | Identical |
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