Manufacturers of disinfectants, sterilants, sanitisers and sanitary preparations in Australia will need to adhere to the requirements of Therapeutic Goods Order No. 54 (TGO 54) in order or registration or listing of their product in the ARTG.
TGO 54 does not apply to the following categories of products –
- sterilant gases;
- antiseptics and skin disinfectants;
- a disinfectant that is represented to be suitable for antifungal use only;
- a disinfectant or sanitiser registered under the Agricultural and Veterinary Chemicals Code Act, 1994 for which no claim or representation for disinfectant use is made other than a use which is registered for the disinfectant;
- a disinfectant or sanitiser that is represented to be suitable for the treatment of water only;
- contact lens care products
A disinfectant is defined by TGO 54 as a substance:
- that is recommended by its manufacturer for application to an inanimate object to kill a range of micro‑organisms; and
- that is not represented by the manufacturer to be suitable for internal use.
The different grades of disinfectants as noted in TGO 54 are –
- Instrument grade – high level disinfectant
- Instrument grade – intermediate level disinfectant
- Instrument grade – low level disinfectant
- Hospital grade disinfectant
- Household / Commercial grade disinfectant
Depending on the grade and the intended application of the disinfectant, varying levels of efficacy data is required to comply with TGO 54.
Mérieux NutriSciences is TGA Licensed and has the capabilities to conduct a wide range of tests methods in compliance with TGO 54.
Disinfectant Efficacy Testing (TGO 54)
- Hospital Grade Disinfectants– TGA Option A, TGA Option B
- Household / Commercial Grade Disinfectants - TGA Option C
- AOAC 991.47, 991.48, 991.49 Hard Surface Carrier Test Method
- AOAC 961.02 Germicidal Spray Products
- AOAC 955.17 Fungicidal Activity of Disinfectants
- BS EN & EN Standards