Originally Published EMDM May/June 2002
INDUSTRY NEWS
Testing Firm Helps OEMs Comply with New Chemical Characterization StandardThe final draft of ISO 10993-18, an international standard for the chemical characterization of materials, is expected to be released some time 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, USA) 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," adds Albert.
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. NAMSA is also expanding its chemistry laboratory to respond to new testing requirements and will organize a seminar series devoted to ISO 10993, parts 1 and 18. The first seminar was held in Santa Clara, CA, USA, in March; others are scheduled for Boston in the spring and Minneapolis in the fall this year.
To obtain a copy of the matrix and for further information, contact NAMSA, 2261 Tracy Rd., Northwood, OH 43619, USA; phone: +1 949 9513110; fax: +1 949 9513280; e-mail: dgibbs@namsa.com; Internet: www.namsa.com.
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