All the raw material and components for the Saint Côme products are biocompatible.
The results of the biocompatibility tests show that the Saint Côme products do not present any biological risk according to the NF EN ISO 10 993-1.

A quality control on 100% of the raw material and components is performed and recorded.
A certificate of compliance from the supplier accompanies each raw material or component

The manufacturing of the products is performed in a clean room ISO 5.

Two quality controls (100% of products) are performed and recorded at each step of manufacturing.

The products are sterilized with ethylene oxide gaz according to a validated process in accordance with EN 550, ISO 11135, EN ISO 11135-1: 2007.

All the sterilization parameters are controlled and recorded for each sterilization lot.

Biological indicator revelation results, estimations of the population of micro-organisms, residual ethylene oxide analysis and sterility tests are performed for each sterilization lot

5 years shelf life sterility for all the products.