13Performance requirements for hospital grade disinfectants

13 Performance requirements for hospital grade disinfectants

General requirements (1) A hospital grade disinfectant must comply with the minimum performance requirements specified in this section for each claim made in relation to the use of the disinfectant on the label, when tested: (a) at the highest dilution recommended on the label for that use; and (b) at the end of the shelf life for that use. Hospital grade disinfectants for general purpose use on surfaces (2) If the disinfectant is for general purpose use on surfaces then, when tested in accordance with the conditions specified on the label (if any), the disinfectant must: (a) pass either of the following tests: (i) the TGA Disinfectant Test, under the conditions specified in Option A or Option B of that test; or (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; and (b) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and (c) if it is a hospital grade disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim. Hospital grade disinfectants that are surface spray disinfectants (3) If the disinfectant is a surface spray disinfectant then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must: (a) pass an appropriate bactericidal carrier test as specified in Division 2 of Part 2 of the Instructions; and (b) if it is a surface spray disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is made pass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim. Hospital grade disinfectant wipes or sponges for single use (4) Subject to subsection (6), if the disinfectant is a disinfectant wipe or sponge that is for single use then, following extraction from the wipe or sponge and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must: (a) pass any of the following tests: (i) the TGA Disinfectant Test under the conditions specified in Option A or Option B of that test; (ii) an appropriate test equivalent to the TGA Disinfectant Test as specified in Division 2 of Part 2 of the Instructions; (iii) an appropriate test for single or multiple use as specified in Division 2 of Part 2 of the Instructions; and (b) if it is a disinfectant wipe or sponge that is for single use for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim. Hospital grade disinfectant wipes or sponges for multiple use (5) Subject to subsection (7), if the disinfectant is a disinfectant wipe or sponge that is for multiple use then, following extraction from the wipe and when tested in accordance with the test conditions specified on the label (if any), the disinfectant must pass an appropriate test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol. Hospital grade disinfectant wipes or sponges for single use where disinfectant cannot be expressed (6) If the disinfectant is a disinfectant wipe or sponge for single use and: (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge; then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must: (c) pass an appropriate simulated in-use test for single use as specified in Division 2 of Part 2 of the Instructions; and (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim. Hospital grade disinfectant wipes or sponges for multiple use where disinfectant cannot be expressed (7) If the disinfectant is a disinfectant wipe or sponge for multiple use and: (a) the amount of disinfectant from such a wipe or sponge that is able to be expressed is not sufficient for testing; or (b) the disinfectant in the wipe or sponge is too dry to be expressed from the wipe or sponge; then, when tested in accordance with the test conditions specified on the label (if any), the disinfectant must: (c) pass an appropriate simulated in-use test for multiple use as specified in Division 2 of Part 2 of the Instructions after the disinfectant has been subjected to a re-use protocol; and (d) if it is a disinfectant for which a claim for sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal use is madepass an appropriate sporicidal, fungicidal, tuberculocidal, virucidal or other biocidal test as specified in Division 2 of Part 2 of the Instructions in relation to each such claim.