Norm

NEN-EN-ISO 10993-12:2006 Ontw. en

Biologische evaluatie van medische hulpmiddelen - Deel 12: Monstervoorbereiding en referentiematerialen

  • Deze norm is ingetrokken sinds 29-11-2007

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Over deze norm

Status Ingetrokken
Aantal pagina's 24
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-03-2006
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 devices testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically this part addresses:-test sample selection;-selection of representative portions from a device;-test sample preparation;-experimental controls;-selection of and requirements for reference materials; and,-preparation of extracts. As described in ISO 14971, in the identification of hazard and risk estimation for medical devices, hazards that arise from changes in the manufacturing process or insufficient control of the manufacturing process should be considered in the design and preparation of samples for test and preparation of extracts of those devices. Particular attention should be given to residues, e.g. trace elements and cleaning and disinfection agents, of those manufacturing processes. The applicability of this standard to tissue engineered medical products and materials of biological origin should be carefully evaluated.

Details

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

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