DIN EN 13612:2002-08
Current
The latest, up-to-date edition.
PERFORMANCE EVALUATION OF IN-VITRO DIAGNOSTIC MEDICAL DEVICES
Hardcopy , PDF
German
01-01-2002
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
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