Article 18 Inspection, maintenance, repair and functionality testing

Procedures for inspection, maintenance, repair and functionality testing referred to in point (g) of Article 11 shall cover the following, if applicable:

1. (a)

   method(s) and performance criteria for inspection;

2. (b)

   method(s) to be used for adjustment, reparation and/or calibration;

3. (c)

   type, amount and method of application of lubricant;

4. (d)

   re-assembly of the single-use device;

5. (e)

   specification of parts that might need to be replaced;

6. (f)

   functionality testing and parameters to be considered for acceptance or rejection.