Norm

NEN-EN-ISO 10993-15:2009 en

Biologische evaluatie van medische hulpmiddelen - Deel 15: Identificatie en kwantificering van afbraakproducten van metalen en legeringen

52,53

Over deze norm

Status Definitief
Aantal pagina's 12
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-07-2009
Taal Engels
This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behavior in the body. The described chemical methodologies are a means to generate degradation products for further assessments. This part of ISO 10993 is not applicable to degradation products induced by applied mechanical stress.

Details

ICS-code 11.100.20
Nederlandse titel Biologische evaluatie van medische hulpmiddelen - Deel 15: Identificatie en kwantificering van afbraakproducten van metalen en legeringen
Engelse titel Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
Vervangt
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

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