A device that is a mammary implant is classified as Class III. Classification examples The following examples are provided to demonstrate the importance of considering all the Classification Rules for a device to ensure that the device is appropriately classified. The examples will not include all the possible devices that may be on the market—they are intended to demonstrate how different variables affect the classification of a device. There may be several Classification Rules that apply to a device—if this happens the higher classification applies, with the exception of medical devices for export only (Rule 5.8), which are classified as Class I. Warming blanket Intended purpose: To re-warm patients who are cold (hypothermic or recovering post-surgery). These patients may be unconscious. Description Variable/comments Classification Classification Rule A large piece of fabric Not powered Rule 2.1 I material blanket specially designed to keep a person warm and/or to prevent the further loss of body heat, often in an emergency situation Blanket used to blow Electrically powered Rule 4.2(2) Class IIb warm air onto patient in Potentially hazardous as patient may get hypothermia, burned or overheated; may have peripheral (person unable to neuropathy (so not able to feel the intensity regulate own body of the heat), may not be able to indicate if temperature) the blanket is too hot (e.g., neonates, unconscious patients). If a patient’s blood pressure is critically low when the therapy is first applied, the applied heat may be detrimental to maintaining adequate blood pressure, as resulting vasodilation reduces blood pressure Nebuliser Intended purpose: To deliver particles of medication/moisture (typically bronchodilators such as salbutamol) to the airways and lungs. Description Variable/comments Classification Classification Rule A compressor that pumps Electrically powered Rule 4.4(1) Class IIa compressed air through the fluid to be nebulised, thus forming droplets/vapour and
A device that is a mammary implant is classified as Class III. Classification examples The following examples are provided to demonstrate the importance of considering all the Classification Rules for a device to ensure that the device is appropriately classified. The examples will not include all the possible devices that may be on the market—they are intended to demonstrate how different variables affect the classification of a device. There may be several Classification Rules that apply to a device—if this happens the higher classification applies, with the exception of medical devices for export only (Rule 5.8), which are classified as Class I. Warming blanket Intended purpose: To re-warm patients who are cold (hypothermic or recovering post-surgery). These patients may be unconscious. Description Variable/comments Classification Rule Classification A large piece of fabric material blanket specially designed to keep a person warm and/or to prevent the further loss of body heat, often in an emergency situation Not powered Rule 2.1 I Blanket used to blow warm air onto patient in hypothermia, (person unable to regulate own body temperature) Electrically powered Potentially hazardous as patient may get burned or overheated; may have peripheral neuropathy (so not able to feel the intensity of the heat), may not be able to indicate if the blanket is too hot (e.g., neonates, unconscious patients). If a patient’s blood pressure is critically low when the therapy is first applied, the applied heat may be detrimental to maintaining adequate blood pressure, as resulting vasodilation reduces blood pressure Rule 4.2(2) Class IIb Nebuliser Intended purpose: To deliver particles of medication/moisture (typically bronchodilators such as salbutamol) to the airways and lungs. Description Variable/comments Classification Rule Classification A compressor that pumps compressed air through the fluid to be nebulised, thus forming droplets/vapour and Electrically powered Rule 4.4(1) Class IIa
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