Article 19 Packaging
United Kingdom
1.
Procedures for packaging referred to in point (h) of Article 11 shall cover the following, if applicable:
(a)
material specification;
(b)
compliance with the specific sterilization or disinfection method;
(c)
limits on packaging process parameters, including sealing temperature;
(d)
criteria for acceptance or rejection.
2.
The packaging and the instructions for use of the reprocessed single-use device shall not bear the CE mark.