2. Control and validation of medical device sterilization processes using microbiological methods

by Corinne DANAN and Cyril VADROT

Medical devices are defined as a category of healthcare products distinct from drugs. They are used in humans for medical purposes, but their action is not obtained by pharmacological, immunological or metabolic means (e.g. probes, prostheses, compresses, etc.), according to Article L-5211-1 of the French Public Health Code. Directive 93/42/EEC , translated into French law in 1998, distinguishes four classes of medical devices and defines the essential requirements for each, according to the risks associated with their use.

Sterilization is one of the requirements for invasive...