Norm

NEN-EN-ISO 10993-10:2013 en

Biologische evaluatie van medische hulpmiddelen - Deel 10: Beproevingen voor het opsporen van irritatie en huidgevoeligheid

161,21

Over deze norm

Status Definitief
Aantal pagina's 67
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-09-2013
Taal Engels
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This part of ISO 10993 includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; b) details of in vivo (irritation and sensitization) test procedures; c) key factors for the interpretation of the results. Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.

Details

ICS-code 11.100.20
Nederlandse titel Biologische evaluatie van medische hulpmiddelen - Deel 10: Beproevingen voor het opsporen van irritatie en huidgevoeligheid
Engelse titel Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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