The Therapeutic Goods Administration (TGA) of the Australian Department of Health and Aged Care is responsible for regulating the quality of therapeutic goods including medical devices, medicines, disinfectants and sterilants, to name a few. Focusing on disinfectants, the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 was established, with the latest 2022 revision in force, to ensure quality, safety and efficacy standards of disinfectants marketed in Australia. Following this, TGA published a detailed guideline of instructions for disinfectant testing, highlighting the efficacy test requirements for specific claims for disinfectants and sterilants.

In this instruction document, TGA lays out a wide range of testing that you could perform according to international standards such as EN, AOAC, ASTM, and US EPA, all of which would be acceptable by TGA in demonstrating product performance. Without being familiar with these international standards and test methods, it is possible that this document may be a little daunting to you. Out of all these options, which test should you do? How do you decide?

Here, we have summarized the scope of tests to perform based on your type of product and specific claims you want for your product.