Norm

NEN-EN-ISO 14155-1:2009 en

Klinisch onderzoek van medische hulpmiddelen voor gebruik bij mensen - Deel 1: Algemene eisen

  • Deze norm is ingetrokken sinds 09-05-2012

106,87

Over deze norm

Status Ingetrokken
Aantal pagina's 21
Commissie Klinisch onderzoek
Gepubliceerd op 01-08-2009
Taal Engels
This part of ISO 14155 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to protect human subjects, ensure the scientific conduct of the clinical investigation, assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices. This part of ISO 14155 a) specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device, b) specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device, c) is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects. This part of ISO 14155 is not applicable to in vitro diagnostic medical devices.

Details

ICS-code 11.100
11.100.20
Nederlandse titel Klinisch onderzoek van medische hulpmiddelen voor gebruik bij mensen - Deel 1: Algemene eisen
Engelse titel Clinical investigation of medical devices for human subjects - Part 1: General requirements
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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