1Use of medical devices not to compromise health and safety

#### 1 Use of medical devices not to compromise health and safety A medical device is to be designed and produced in a way that ensures that: (a) the device will not compromise the clinical condition or safety of a patient, or the safety and health of the user or any other person, when the device is used on a patient under the conditions and for the purposes for which the device was intended and, if applicable, by a user with appropriate technical knowledge, experience, education or training; and (b) any risks associated with the use of the device are: (i) acceptable risks when weighed against the intended benefit to the patient; and (ii) compatible with a high level of protection of health and safety.