We propose the passivation of stainless steel and titanium medical devices by means of processes developed and validated by our expert team as per IQ OQ PQ PPQ principles, in accordance with the requirements of ISO 13485 and 21CFR820s.
Based on biodegradable products, these processes draw on the latest medical reference systems an,d make it possible to obtain a particularly effective nitric-acid-free treatment, so ensuring reproducible results coupled with ISO-10993-compliant biocompatibility.
Through elimination of iron particles and other foreign bodies, our passivation of stainless steel makes it possible to develop a uniforme and compact layer on the surface of the alloy. The oxide layer formed bolsters the material's corrosion resistance by acting as a barrier against aggressuve agents. Validated on a broad range of stainless steels used for the manufacture of surgical instruments and implants, our process enables treatment of austenitic, marstensitic and austenitic-feritic steels.
The passivation of titanium alloys which we can offer makes it possible to rid medical devices of any contaminants such as ferrous ions and machining oils chile alos developing an oxide layer in a much purer way than by spontaneous oxidation in an uncontrolled environment.
Validation studies conducted wih the most critical corrosion, toxicity and cytotoxicity tests on the different alloys have enabled us to verify the effectiveness of the process through improved resistance to corrosion and biocompatibility.
In addition to ensuring the enhanced corrosion resistancce of medical implants and instruments, passivation also makes it possible to stabilise laser marking on products.
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