Norm

NEN-EN-ISO 10993-13:2008 Ontw. en

Biologische evaluatie van medische hulpmiddelen - Deel 13: Identificatie en kwantificering van degradatie producten van medische hulpmiddelen van polymeer

  • Deze norm is ingetrokken sinds 30-06-2010

25,62

Over deze norm

Status Ingetrokken
Aantal pagina's 23
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-08-2008
Taal Engels
This part of ISO 10993 provides general requirements for the d esign of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medic al devices ready for clinical use. This part of ISO 10993 desc ribes two test methods to generate degradation products, an ac celerated degradation test as a screening method and a real-ti me degradation test in a simulated environment. For materials which are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the b iological evaluation of the polymer. This document considers o nly non-resorbable polymers. Similar, but appropriately modifi ed procedures may be applicable for resorbable polymers. This part of ISO 10993 considers only those degradation products ge nerated by a chemical alteration of the finished polymeric dev ice. It is not applicable to during its intended use by mechanical stress, wear or electro magnetic radiation or biological factors such as enzymes, othe r proteins and cellular activity. degradation of the device induced

Details

ICS-code 11.100.20
Nederlandse titel Biologische evaluatie van medische hulpmiddelen - Deel 13: Identificatie en kwantificering van degradatie producten van medische hulpmiddelen van polymeer
Engelse titel Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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