NS EN 13612 : 1ED 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

Specifies performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. Also defines the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer.