April 7, 2002

2 Min Read
Testing Firm Helps OEMs Comply with New Chemical Characterization Standard

Originally Published MPMN April 2002


Testing Firm Helps OEMs Comply with New Chemical Characterization Standard

Norbert Sparrow


In preparation for the impact of ISO 10993-18, NAMSA's chemistry laboratory is expanding to accommodate analytical instrumentation such as HPLC/MS, HPLC/FTIR, GC, and GCMS.

The final draft of ISO 10993-18, an international standard for the chemical characterization of materials, is expected to be released sometime in 2003. The standard details the characterization procedures that device manufacturers should follow to gain market clearance for their products from regulatory bodies. Nonclinical testing services provider NAMSA (Northwood, OH; www.namsa.com) has announced that it will begin implementing measures to help the device industry address specific part-18 requirements for testing programs.

"The final draft . . . reflects the increasing importance of ensuring the safety of the materials used in medical devices as the number of polymers, elastomers, and alloys used in biomedical applications expands," says NAMSA senior scientist and chief chemist David Albert. "This will include the increased use of analytical techniques to identify chemical constituents, along with biological risk assessments to determine their compatibility with the human body," he adds.

NAMSA is making available a chemical characterization matrix that mimics the format of its four-phase approach to medical device safety evaluation. This matrix provides direction on tests that should be performed based on the classification of a device. Readers interested in obtaining a copy should contact Deborah Gibbs in corporate marketing by phoning 949/951-3110 or sending an e-mail to [email protected]. NAMSA is also expanding its chemistry laboratory to respond to new testing requirements and will organize a national seminar series devoted to ISO 10993, parts 1 and 18. The first seminar was held in Santa Clara, CA, in March; others are scheduled for Minneapolis in the spring and Boston in the fall.

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