All the raw material and components for the Saint Côme products are biocompatible.

The results of 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 furnished accompanies each raw material or component.

The products are manufactured in a clearoom in which the concentration of airborne particles, the pressure between zones, the concentration of airborne biological organisme, the concentration of biological organisms on surfaces and in water is quaterly controlled.

The results show the quality of the cleanroom regarding the airbone particles and the biological organisms.

Other relevant parameters like temperature, humidity and pressure are controlled daily.

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

The products are sterilized with gamma radiations according to a validated process compliant with the EN 552 norm or with ethylene oxide gas to a validated process compliant with the EN 550 norm.

The compliance of the sterilization parameters is controlled and recorded for each sterilisation lot.

A quarterly control of initial contamination on the finished products is performed.

The products are sterile for 5 years from the sterilization date.

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Quality System

Saint Côme Chirurgie : 14 Rue du Vieux Faubourg - CS 30028
59042 LILLE CEDEX - FRANCE
Tel: +33 (0) 359 569 776 - Fax: +33 (0) 359 569 777
@mail: saintcome@inter.net