Norm

NEN-EN-ISO 10993-12:2007-02 en

Biologische evaluatie van medische hulpmiddelen - Deel 12: Monstervoorbereiding en referentiematerialen (Corrected and reprinted)

  • Deze norm is ingetrokken sinds 20-05-2009

79,70

Over deze norm

Status Ingetrokken
Aantal pagina's 17
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-11-2007
Taal Engels
This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically this part of ISO 10993 addresses: - test sample selection; - selection of representative portions from a device; - test sample preparation; - experimental controls; - selection of and requirements for reference materials; - preparation of extracts. This part of ISO 10993 is not applicable to materials or devices containing live cells.

Details

ICS-code 11.100.20
Nederlandse titel Biologische evaluatie van medische hulpmiddelen - Deel 12: Monstervoorbereiding en referentiematerialen (Corrected and reprinted)
Engelse titel Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (Corrected and reprinted)
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Normatieve verwijzingen
  • 90/385/EEG, Actieve implanteerbare medische hulpmiddelen (pacemaker richtlijn)

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