Therapeutic Goods Act 1989

Without limiting the scope of section 41CB, an order establishing a medical device standard for kinds of medical devices may be specified by reference to:

the safety or performance characteristics of the devices; or

a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary; or

a monograph in a publication approved by the Minister for the purposes of this subsection; or

such a monograph as modified in a manner specified in the order; or

a standard published by a standards organisation; or

such other matters as the Minister thinks fit.

For the purposes of paragraph (1)(e), these are standards organisations:

Standards Australia;

the International Organisation for Standardization;

the International Electrotechnical Commission;

the European Committee for Standardization;

the European Committee for Electrotechnical Standardization;

any other organisation declared by the Minister by notice published in the Gazette or on the Department’s website.