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Metal allergies are a growing cause of concern for the medical device industry. Exposure to metal ions released from the normal wear of medical implants can lead to adverse side effects such as hypersensitivity, implant loosening and premature device failure, which can cause life-threatening outcomes. The European Union’s Medical Device Regulation (EU MDR) implements changes to limit the cobalt content in medical devices without a definitive solution. This regulatory update creates a vast disconnect between device manufacturers and material suppliers. Commonly used stainless steel alloys such as 300 series, 400 series, custom 455 and custom 465 typically contain 0.5-0.40 wt% cobalt, which is attributed to impurities during the melting process. The trace amount of cobalt makes these alloys non-compliant with the EU MDR.
In this webinar, Carpenter Technology presents recent material advancements to produce EU MDR-compliant low-cobalt stainless steel alloys. The company also discusses the applications of BioDur 734 (cobalt-free stainless) and BioDur 108 (cobalt- and nickel-free stainless) alloys for the medical device industry.
The webinar provides attendees with a comprehensive understanding of metal allergies, regulatory changes, material advancements and alternative alloys for manufacturing EU MDR-compliant stainless steels for medical devices.
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