Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance

This Part of this European Standard provides guidance on the implementation of the requirements specified in EN 1174-1. It is aimed at providing a better understanding of EN 1174-1 as well as assisting in implementing its requirements. The guidance given is not intended to be exhaustive, but to highlight important aspects to which attention should be given. NOTE: This Part of EN 1174-1 is informative and does not contain requirements. This Part of this European Standard is not intended as a checklist for assessing compliance with EN 1174-1.