Article 13 Preparation before cleaning

Procedures for preparation before cleaning referred to in point (c) of Article 11 shall cover the following, if applicable:

1. (a)

   requirements for disassembly of the single-use device;

2. (b)

   capping or opening of ports;

3. (c)

   leak testing;

4. (d)

   special soaking or brushing techniques and ultrasonic treatment of the single-use device.