The ISO 10993-2 standard, developed by the International Standards Organization (ISO), describes the conditions and test methods required for animal welfare during the biological evaluation of medical equipment. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 10993-2 Biological evaluation of medical devices - Part 2: Requirements for animal welfare.
The mentioned standard is intended for those who use, commission, design and evaluate data obtained from animal tests to evaluate the biocompatibility of medical devices or materials intended for use in medical devices. This standard specifies minimum requirements to assess the biocompatibility of materials used in medical devices to ensure appropriate conditions for the welfare of animals used in tests.
The ISO 10993-2 standard also makes recommendations aimed at further reducing the total number of animals used, improving testing methods to reduce or eliminating pain and distress to animals, and replacing animal tests with other scientifically valid tests. In short, it requires avoiding animal tests as much as possible.
This standard includes tests on living vertebrate animals other than humans to determine the biocompatibility of materials or medical devices.
In general, the aim of the ISO 10993 series of standards is to encourage the maximization of the use of scientifically sound non-animal testing and to permit animal testing to evaluate the biological properties of materials used in medical devices by promoting science. The main goal is to ensure the application of humane testing methods and the scientific validity of safety tests, and to minimize pain and suffering to improve the welfare of the animals used.
Our organization also provides the necessary conditions and testing services for animal welfare during the biological evaluation of ISO 10993-2 medical equipment within the scope of laboratory services.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
