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
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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