Norm

NEN-EN-ISO 10993-9:2010 en

Biologische evaluatie van medische hulpmiddelen - Deel 9: Raamwerk voor de identificatie en kwantificering van potentiƫle afbraakproducten

52,53

Over deze norm

Status Definitief
Aantal pagina's 9
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-01-2010
Taal Engels
This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This part of ISO 10993 considers both non-resorbable and resorbable materials. This part of ISO 10993 is not applicable to: a) evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available

Details

ICS-code 11.100.20
Nederlandse titel Biologische evaluatie van medische hulpmiddelen - Deel 9: Raamwerk voor de identificatie en kwantificering van potentiƫle afbraakproducten
Engelse titel Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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