NS-EN ISO 14155:2011

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Status: Alert Tilbaketrukket
Norsk tittel: Klinisk undersøkelse av medisinsk utstyr til bruk på mennesker — God klinisk praksis (ISO 14155:2011)
Engelsk tittel: Clinical investigation of medical devices for human subjects — Good clinical practice (ISO 14155:2011)
Varetype: Standard
Språk: Engelsk
Utgave: 2011-10 (2011-05-01)
Erstatter: NS-EN ISO 14155-1:2009 Alert Tilbaketrukket
NS-EN ISO 14155-2:2009 Alert Tilbaketrukket
Erstattes av: NS-EN ISO 14155:2020 Check Gyldig
Antall sider: 72
Pris:

NOK 794,00 (eks. mva)
NOK 992,50 (ink. mva)

Inkludert i: NS ICS 11
NS ICS 11.100
NS ICS 11.100.20
NS og NS-EN komplett (eks NS-EN ISO)
Omfang: ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes. The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations. ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. ISO 14155:2011 does not apply to in vitro diagnostic medical devices.
Komité: SN/K 113
Fastsatt: 2011-05-01
Tilbaketrukket: 2020-09-07
ICS: 11.100.20 - Biologisk evaluering av medisinsk utstyr