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Tag Archives: ASTM F138

Providing Risk Mitigation Solutions to the Medical Implant, Device, and Instrument Communities Through Ultrasonic Testing Capability and Expertise

CAROL STREAM, ILLINOIS – The demand has never been greater for specialized supply chains that deliver medical materials to meet the production demands of OEM’s. These businesses are acutely aware of the need to use quality metals and materials in their products to assure performance, durability and long-term reliability. Due to the recent revisions to ASTM standards F136 and F138, Banner Medical has installed a multi-axis, computer controlled Ultrasonic Inspection System designed and built by Matec Inspection Companies, Inc., for precision ground bars.

ASTM F136 and ASTM F138 are commonly specified standards in the design of titanium and stainless steel surgical implants; and recent revisions to each standard call for ultrasonic testing at final diameter for all centerless ground, or peeled and polished bars, which are greater than or equal to .375” in diameter.

“The decision to purchase this highly versatile inspection system was driven by the current and future needs of our customers. We are experiencing greater demand for ultrasonic testing of medical grade raw materials and the recent changes to ASTM standards F136 and F138 will increase demand even further in the very near term,” said Bob Khin, Vice President of Quality Assurance, Banner Medical.

“We recognize the impact these revisions will have on our customers. Ultrasonic testing at final diameter has the potential to add significant delays and cost to the supply chain. Our new ultrasonic inspection unit allows us to ensure the precision of centerless grinding and testing under one roof. We are providing our customers with a cost effective, time saving solution to the problems which could arise as manufacturers begin to comply with these changes. We will maintain the inventory, production capability, and testing equipment in a medical focused factory,” said Dan Stoettner, Executive Vice President and Chief Operating Officer.

To fully comply with industry testing standards, Banner Medical has hired additional qualified personnel to operate the equipment and implement the proper management systems including Rick Wallen, Director of Technical Services. He will assume full responsibility for the ultrasonic testing program. Rick was employed at Zimmer Inc. for 34 years in various roles and most recently served as Principal Engineer, Quality. He was responsible for all nondestructive testing requirements company-wide.

“We feel very fortunate to have Rick join our team. He is an industry recognized expert in ultrasonic testing and Quality Management Systems, and we are certain he will make an immediate impact within our organization. Rick is an ASTM certified Level III Engineer and an ASQ certified Quality Auditor. He is going to help us provide the very best service to our customers,” said Bob Khin.

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Banner Medical serves the medical device, implant, and instrument industry with medical-grade metal materials; Banner Medical is ISO 13485 and ISO 9001 certified, and FDA CFR part 820 compliant.

For more information:

BILL NORLANDER
Medical Products Specialist
494 East Lies Road
Carol Stream, IL 60188-9425
P:630.868.1230
F:630.653.7555
E: bnorlander@banner-medical.com
www.banner-medical.com

MIKE HADLEY
Supply Chain Manager
494 East Lies Road
Carol Stream, IL 60188-9425
P:630.868.1229
F:630.653.7555
E: mhadley@banner-medical.com
www.banner-medical.com

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