NEN-EN 540:1994 en

Klinisch onderzoek van medische hulpmiddelen voor gebruik bij mensen

  • Deze norm is ingetrokken sinds 25-03-2003


Over deze norm

Status Ingetrokken
Aantal pagina's 10
Commissie Klinisch onderzoek
Gepubliceerd op 01-05-1994
Taal Engels
This standard pertains to the clinical investigation in human subjets of those medical devices whose the clinical performance needs assessment before being placed on the market. This standard does not apply to in vitro diagnostic devices. This standard specifies the requirements - for the conduct of clinical investigations and documentation on whether the medical device achieves the performance intended by the sponsor; - to determine any undesirable side effects, under normal conditions of use; - to permit the assessment of the acceptable risks having regard to the intended performance of the medical device. This standard provides a framework for the preparation of written procedures for the organization, design, implementation, data collection and documentation of the clinical investigation.


ICS-code 11.040.01
Nederlandse titel Klinisch onderzoek van medische hulpmiddelen voor gebruik bij mensen
Engelse titel Clinical investigation of medical devices for human subjects
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen



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