Division 2.5

Packaging systems for devices other than those referred to in section 2.3 must keep the product without deterioration at the level of cleanliness indicated by the manufacturer and, if the devices are to be sterilised prior to use, reduce as far as possible the risk of microbial contamination.

Steps must be taken to reduce as far as possible microbial contamination during selection and handling of raw materials, manufacture, storage and distribution where the performance of the device can be adversely affected by such contamination.