Guidance for Risk-Based Qualification of New Technology

Qualification is a process by which a new technology or an existing technology used in a new context is validated. The qualification process is intended to prove with an acceptable level of confidence and in a cost effective manner that a technology is fit for purpose, that it complies with the specifications that the designer developed and that it is sufficiently reliable and is safe for the people and the environment.

The detailed guidelines cover how to analyse the service conditions for which a novel technology is designed, identify the possible resulting failure modes which it needs to withstand and against which it needs to be qualified and how to establish the relevant qualification program. The qualification process should combine both theoretical analytical modelling and physical tests.