7.5.11 Preservation of product

The organization shall document procedures for preserving the conformity of product to requirements

during processing, storage, handling, and distribution. Preservation shall apply to the constituent parts

of a medical device.



The organization shall protect product from alteration, contamination or damage when exposed to

expected conditions and hazards during processing, storage, handling, and distribution by:

a) designing and constructing suitable packaging and shipping containers;

b) documenting requirements for special conditions needed if packaging alone cannot provide

preservation.

If special conditions are required, they shall be controlled and recorded (see 4.2.5).