DS/EN ISO 10993-2:2006

Biological evaluation of medical devices - Part 2: Animal welfare requirements

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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.
NOTE – It should be ensured, that this part of ISO 10993 is properly referenced in other standards of the ISO 10993 series.

Number of pages: 28

Published: 2006-11-28

Date of approval: 2006-10-13

International relationships : EN ISO 10993-2:2006 IDT ISO 10993-2:2006 IDT

ICS: 11.100.01 - Laboratory medicine in general 11.100.20 - Biological evaluation of medical devices

Item number: 53352



  • CEN/TC 206
  • ISO/TC 194/WG 3

Danish committee