Division 1.2.7 Tissues or derivatives of animal origin coming into contact with the patients and users

The manufacturer must consider:

1. (a)

   the maximum quantity of animal tissues or derivatives coming into contact with the patient or user when using a single medical device;

2. (b)

   the contact area: its surface, type (e.g. skin, mucous tissue, brain) and condition (e.g. healthy or damaged);

3. (c)

   the type of the tissues or derivatives coming into contact with the patients or users;

4. (d)

   the period of time the device is intended to remain in contact with the body (including bioresorption effect); and

5. (e)

   the number of medical devices that could be used in a given procedure or, if possible, over the lifetime of a patient or user.