You may be required to comply with this standard if you intend to manufacture disinfectants and sterilants.
The standard details the requirements for the packaging, labelling, composition and performance of disinfectants and sterilants. The requirements are considered to be the minimum information that should appear on the label of a disinfectant or sterilant to ensure its safe use and to enable it to be traced to the sponsor and to a particular cycle of manufacture if the need arises. It applies to all disinfectants, sterilisers, sanitisers and sanitary preparations except:
- 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.
Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.
Code of Practice
A code of practice can be either a legal requirement or non-legal requirement. Legal codes of practice are defined as a result of legislation. Non-legal codes of practice are defined by industry regulators and bodies.
Department of Health
Therapeutic Goods Administration
Therapeutic Goods Act 1989 (Australian Government)
Therapeutic Goods Order No. 54 - Standard for Disinfectants and Sterilants 1996 (Australian Government)
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