Sheet metal parts for medical applications must undergo biocompatibility certification,
which primarily covers aspects such as material selection, surface treatment, and testing standards.
Biocompatibility Certification Requirements
Sheet metal parts used in the medical field must comply with ISO 10993 standards to ensure that they do not produce harmful reactions when in contact with human tissue or body fluids. For example, components such as surgical instrument trays and imaging equipment holders must be made of certified materials such as 316L stainless steel and avoid heavy metal leachate (e.g., lead and cadmium content ≤ 0.1 μg/cm²).
Material and Process Requirements
Material Selection: Materials that have passed biocompatibility testing, such as 304/316L stainless steel and medical-grade aluminum alloys, are preferred. Surface treatment must utilize electrolytic polishing or passivation, and the use of chemicals containing hexavalent chromium is prohibited. Welding Processes: Laser welding, argon arc welding, and other processes must ensure a residue-free weld seam and a surface roughness of Ra ≤ 0.8μm. Some components require industrial CT scanning to detect internal pores.
Testing and Verification
Biocompatibility testing (such as cytotoxicity and skin irritation tests) and a medical device registration certificate must be obtained. Specialty components (such as joints) must additionally meet ISO 13485 standards.
Sheet metal parts that have not passed biocompatibility certification may cause allergic reactions or infection risks, directly impacting medical safety.
Of course, if you need large quantities of medical sheet metal parts, you can partner with Mulan Group. Mulan Group has 12 years of experience in sheet metal manufacturing and processing, and possesses comprehensive certifications to meet the sheet metal certification requirements of various industries. We have supported customers in over 30 countries with their sheet metal manufacturing operations and have received widespread recognition. We look forward to your consultation and cooperation.
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