ISO/TC 194/WG 3 - Animal protection aspects

ISO 10993-2:2006 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. ISO 10993-2:2006 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.

Specifies minimum requirements for the use of animals in biological testing. Is also intended to establish guidelines which allow the scientist to respect life in general, to reduce the number of animal experiments and the number of animals used in experiments, to minimize suffering and maintain the quality of life of the animals used in the experiments. Applies to the experimentation performed on vertebrates.