Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41cc
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41CC
Character Range: 653103–654233

41CC  Content of medical device standards
 (1) 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:
 (a) the safety or performance characteristics of the devices; or
 (b) a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary; or
 (c) a monograph in a publication approved by the Minister for the purposes of this subsection; or
 (d) such a monograph as modified in a manner specified in the order; or
 (e) a standard published by a standards organisation; or
 (f) such other matters as the Minister thinks fit.
 (2) For the purposes of paragraph (1)(e), these are standards organisations:
 (a) Standards Australia;
 (b) the International Organisation for Standardization;
 (c) the International Electrotechnical Commission;
 (d) the European Committee for Standardization;
 (e) the European Committee for Electrotechnical Standardization;
 (f) any other organisation declared by the Minister by notice published in the Gazette or on the Department's website.