Norm

NEN-EN-ISO 10993-9:2009 en

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

  • Deze norm is ingetrokken sinds 11-01-2010

52,53

Over deze norm

Status Ingetrokken
Aantal pagina's 8
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-06-2009
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. This part of ISO 10993 is not applicable to: a) viable-tissue engineered products; b) methodologies for the generation of degradation products by mechanical processes. Methodologies for the production of this type of degradation product are described in specific product standards, where available; c) leachable components which are not degradation products. Where product standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards shall be considered as alternatives.

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
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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