PVD Coatings in Medical Devices Industry - Bio-compatibility

PVD Coatings With Biocompatibility Testings

The biocompatibility of a coating is a prerequisite to its use on medical devices.

For this reason, we has tested the biocompatibility of all the coatings that it applies, with the exception of TiN, which has been widely reported to be biocompatible.

Coatings are certified biocompatible based on a series of tests conducted by an independent biological-testing laboratory. These tests were conducted in accordance with ISO 10993-1 guidelines for materials that experience short-term body contact. The results indicate that TiN, ZrN, CrN, TiAlN, AlTiN are acceptable for external and internal medical devices that contact bone, skin tissue or blood.

Biocompatibility tests completed include the following:

1. Sensitization: no significant evidence of causing delayed dermal contact sensitization in a guinea pig.

2. Cytotoxicity: no evidence of causing cell lysis or toxicity.
3. Acute Systemic: no significant systemic toxicity or mortality.
4. Intracutaneous: no evidence of significant irritation or toxicity in rabbits.
5. Genotoxicity: not mutagenic.
6. USP Muscle: non-irritating to muscle tissue.
7. Hemolysis: nonhemolytic, compatible with blood.

Note: The data generated from laboratory samples. Coating films properties may vary depending on customer's material, surface condition ( high polished or others) and products 3D geometry.)

Reference:

1. Pappas and Buechel, 41st Annual ORS Meeting, March 1994.

2. Coll et al, Surface Coating Technology, 1988.

Please contact us to find the suitablel PVD coating solutions and PVD coater systems for your products.