Medical devices should be designed and manufactured in such a
Way that, when used under the conditions and for the purposes
Intended and where applicable, by virtue of the technical knowledge, experience, education or training of intended users,
They will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety