Division 1.2.5.2 For other devices, if claims are made by the manufacturer for the ability of manufacturing processes to remove or inactivate TSE infectious agents, these must be substantiated by appropriate documentation.

Relevant information from an analysis of appropriate scientific literature can be used to support inactivation and elimination factors, where the specific processes referred to in the literature are comparable to those used for the device. This search and analysis shall also cover the available scientific opinions that may have been adopted by an F1... international scientific committee or body. These opinions are to serve as a reference, in cases where there are conflicting opinions.

If the literature search fails to substantiate the claims, the manufacturer must set up a specific inactivation or elimination study, as appropriate, on a scientific basis and the following need to be considered:

1. (a)

   the identified hazard associated with the tissue;

2. (b)

   identification of the relevant model agents;

3. (c)

   rationale for the choice of the particular combinations of model agents;

4. (d)

   identification of step and/or stage chosen to eliminate or inactivate the TSE infectious agents;

5. (e)

   documentation of the parameters for any TSE inactivation or elimination validation study;

6. (f)

   calculation of the reduction factors.

The manufacturer must apply appropriate documented procedures to ensure that the validated processing parameters are applied during routine manufacture.

A final report must identify manufacturing parameters and limits that are critical to the effectiveness of the inactivation or elimination process.