PROVIDED that the requirement of Transmissible Spongiform Encephalopathies (TSEs) or Bovine Spongiform Encephalopathy (BSE) Certificates is not necessary, if the source is from an animal species from a country of origin recognised as having negligible Bovine Spongiform Encephalopathy risk in accordance with the recommendations of the World Organisation for Animal Health.] (ii) The system for record-keeping to allow traceability from sources to the finished device should be fully described. 7.5 Sterilization: (i) Where the device is supplied sterile, the dossier should contain the detailed information of the initial sterilization validation including Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. sterilizer qualification, bio-burden testing, pyrogen testing, testing for sterilant residues (if applicable) and packaging validation as per prescribed standards. Typically, the detailed validation information should include the method used, sterility assurance level attained, standards applied, the sterilization protocol developed in accordance with prescribed standards, and a summary of results.