1 Scope
This document 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 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 that of the medical devices themselves.
This document 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.
This document applies to tests performed on living vertebrate animals , other than man, to
establish the biocompatibility of materials or medical devices.
This document 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 euthanized.
BS EN ISO 10993-2:2022 Referenced Document
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
BS EN ISO 10993-2:2022 history
2022BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
2006BS EN ISO 10993-2:2006 Biological evaluation of medical devices - Animal welfare requirements