12/11/2023 0 Comments Incontrol medical device![]() ![]() (b) in respect of any other medical device, the requirements set out in section 10, subsections 11(1) and 12(1) and sections 13 to 20. ( exigences applicables prévues aux articles 10 à 20)īar code means a unique bar code in the symbology of the Universal Product Code (UPC), the Health Industry Business Communications Council (HIBCC) or the European Article Number (EAN), assigned to a medical device by the manufacturer. ( code à barres) body orificeīody orifice means a natural opening or a permanent artificial opening in the body, such as a stoma. ( orifice du corps) business day (a) in respect of a decorative contact lens, the requirements set out in section 10, subsections 11(2) and 12(2) and sections 13 to 17 and A medical device that transmits or withdraws energy or a substance to or from a patient without substantially altering the energy or the substance is not an active device. ( instrument actif) active diagnostic deviceĪctive diagnostic device means an active device that, whether used alone or in combination with another medical device, is intended to supply information for the purpose of detecting, monitoring or treating a physiological condition, state of health, illness or congenital deformity. ( instrument diagnostique actif) active therapeutic deviceĪctive therapeutic device means an active device that, whether used alone or in combination with another medical device, is intended to support, modify, replace or restore a biological function or structure for the purpose of treating or mitigating an illness or injury or a symptom of an illness or injury. ( instrument thérapeutique actif) applicable requirements of sections 10 to 20Īpplicable requirements of sections 10 to 20 means ActĪct means the Food and Drugs Act. ( Loi) active deviceĪctive device means a medical device that depends for its operation on a source of energy other than energy generated by the human body or gravity. 73ġ The definitions in this section apply in these Regulations. ![]()
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