Norm

NEN-EN-ISO 10993-14:2009 en

Biologische evaluatie van medische hulpmiddelen - Deel 14: Identificatie en kwantificering van degradatieproducten van keramieken

52,53

Over deze norm

Status Definitief
Aantal pagina's 11
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-05-2009
Taal Engels
This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analysis of these solutions in order to identify the degradation products. Because of the generalized nature of this part of ISO 10993, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first. This part of ISO 10993 considers only those degradation products generated by a chemical dissociation of ceramics during in vitro testing. No degradation induced by mechanical stress or external energy is covered. It is noted that while ISO 6872 and ISO 9693 cover chemical degradation tests, they do not address the analysis of degradation products. Because of the range of ceramics used in medical devices and the different requirements for accuracy and precision of the results, no specific analytical techniques are identified. Further, this part of ISO 10993 provides no specific requirements for acceptable levels of degradation products.

Details

ICS-code 11.100.20
Nederlandse titel Biologische evaluatie van medische hulpmiddelen - Deel 14: Identificatie en kwantificering van degradatieproducten van keramieken
Engelse titel Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
Vervangt
Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

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