NS-EN ISO 10993-1:2009

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Status: Alert Tilbaketrukket
Norsk tittel: Biologisk evaluering av medisinsk utstyr — Del 1: Evaluering og prøving (ISO 10993-1:2003)
Engelsk tittel: Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Varetype: Standard
Språk: Engelsk
Utgave: 2009-10 (2009-09-01)
Erstatter: NS-EN ISO 10993-1:2003 Alert Tilbaketrukket
Erstattes av: NS-EN ISO 10993-1:2020 Check Gyldig
Antall sider: 28
Pris:

NOK 775,00 (eks. mva)
NOK 968,75 (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 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyse the biological safety of the medical device; the assessment of the biological safety of the medical device.
Komité: SN/K 115
Fastsatt: 2009-09-01
Tilbaketrukket: 2021-01-15
ICS: 11.040.01 - Medisinsk utstyr generelt
11.120.10 - Medikamenter
11.100 - Laboratoriemedisin
11.100.20 - Biologisk evaluering av medisinsk utstyr