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and does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. Software as Medical Device (SaMD): An SaMD in Australia is defined as a software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. In Vitro diagnostic Device (IVD) An in vitro diagnostic medical device (IVD) is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use

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These risks can be kept low to insignificant as long as the rubber stopper on the vial does not have significant damage and proper technique is used in withdrawing from the vial