Animal welfare and ISO - the International Organisation for Standardization

The International Organisation for Standardization (ISO) is a world-wide federation of national standards bodies. The work of preparing International Standards is carried out through ISO Technical Committees composed of national experts and in collaboration with international organisations both governmental and non-governmental. The 10993 series of ISO standards deal with the biological safety of medical devices and materials, and provide one means of satisfying regulatory requirements with respect to their biological safety. Although risk assessments must be undertaken on case-by-case basis, these standards establish essential requirements relating to the selection and performance of test methods, including animal tests. ISO Standard 10993-2 sets out the animal welfare provisions to be satisfied if compliance with the 10993 series of standards is to be established and, as the only animal welfare standard produced by ISO, it has also become a normative reference in other ISO standards describing animal use. The last revision of ISO Standard 10993-2 was completed in July 2006, and makes good contemporary provision for the welfare of animals used for biological testing. This paper reviews both the processes and product of this last revision, and commends specific components of the process as good examples where international agreement and collaboration has enabled the production, publication and adoption of a document that takes full account of the 3Rs.