Production process of our surgical instrument

Workshop
Material

Choice of raw material

The materials used to manufacture our instruments comply with the FDA regulations and the French Standardization Norms :

- Stainless steel NFS 90450 - NFS 90451
- Peek and Acetal Copolymer (FDA norms)
- Resin complies with the industry norms 21 CFR 177 24 70 without phtalates
- Titanium used complies with the standards N° AMS 4928 – ASTM B348 - ISO 5832-3

Materials, whether steel or titanium, must be carefully chosen because the PH as well as the ionic conditions in the human body constitute a harmful environment for metals provoking the acceleration of the corrosion process.

Therefore, surgical steel must contain a percentage of Nickel to resist corrosion. Furthermore, the corrosion resistance of surgical steel depends greatly on its surface finish.

Indeed, a rough surface state, which contains roughness, retains the bacteria while a smooth and well polished surface ensures the fact that they do not cling and facilitates the decontamination.

Traceability

In order to guarantee that the raw material we use comply with the FDA regulations, we require an authenticity certificate from our suppliers. In addition, we conduct a rigorous tracking of the raw materials we use, starting from their arrival to the finished products. This is accomplished through a computerized tracking system that allows us to identify all manufacturing steps and materials used by issuing a lot number to the instrument.
Heat

Heat treatment

Heat treatment includes a number of specialized engineering techniques and processes that improve the characteristics of metals and alloys while extending the life of the components; this is one of the most important steps in our manufacturing process. That's why we outsource it to Bodycote, the world's leading provider of heat treatment services. Hardness tests are carried out for each quenching process, and listed in our traceability monitoring.
Quality

Quality Control

We conduct a quality control during all the production process to ensure that the instruments meet the quality standards as well as the dimensions required. Once the production is finished we reexamine the instrument to detect any flaws that hadn’t been noticed before. If the instrument does not respect one of check points, it is stored in non-conformity zone.
Passivation

Passivation

Passivation is the removal of iron compounds from the surface of steel, by means of chemical treatment which removes any surface contamination and forms a very thin protective passive layer. The latter greatly increases the corrosion resistance of steel, which means that the instruments last longer and can withstand regular cleaning and reprocessing.

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