Commonwealth Consolidated Acts

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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.

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