NEN-EN-ISO 10993-2:2004 Ontw. en

Biologisch evaluatie van medische hulpmiddelen - deel 2: Eisen voor het welzijn van dieren

  • Deze norm is ingetrokken sinds 13-10-2006


Over deze norm

Status Ingetrokken
Aantal pagina's 21
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-11-2004
Taal Engels
This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or of the medical devices themselves. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. It does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanised.


ICS-code 11.100.20
Nederlandse titel Biologisch evaluatie van medische hulpmiddelen - deel 2: Eisen voor het welzijn van dieren
Engelse titel Biological evaluation of medical devices - Part 2: Animal welfare requirements
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen



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