Australia Therapeutic Goods (Medical Devices) Regulations 2002 sch1-8.1-8.2: Essential principles 8.1 and 8.2: eliminate or minimise infection risk, make the device easy to handle without cross-contamination, and control non-viable animal, microbial or recombinant tissues and substances with veterinary controls, origin records and validated viral inactivation

What does sch1-8.1-8.2 require?

The device must be designed and produced so that infection risk to patients, users and others is removed or minimised; it must be easy to handle and, where relevant, limit contamination between the device or specimen and people. Where a device contains non-viable animal tissues, cells or substances, or tissues and substances of microbial or recombinant origin, source animals must have been under suitable veterinary control, the country of origin of each source animal must be recorded, processing, preservation, testing and handling must achieve the highest safety standard, and production must use validated methods to remove or inactivate viruses and other transmissible agents (unless, for certain IVDs, those characteristics are integral to the purpose).