7.4 Biological safety: (i) The dossier should contain a list of all materials of animal or human origin used in the device. For these materials, detailed information should be provided concerning the selection of sources or donors; the harvesting, processing, preservation, testing and handling of tissues, cells and substances of such origin should also be provided. Process validation results should be included to substantiate that manufacturing procedures are in place to minimize biological risks, in particular, with regard to viruses and other transmissible agents. Transmissible Spongiform Encephalopathies (TSE) or Bovine Spongiform Encephalopathy (BSE) Certificates should also be submitted: