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Penetration Testing

One of the most important characteristics of a curved surgical needle is how easily it can pass through tissue. This characteristic, known as penetration force, is important for several reasons, which include minimizing scarring during plastic surgery and dealing with highly communicable diseases such as hepatitis.

ASTM International Committee F04 on Medical and Surgical Materials and Devices is currently developing a proposed standard that covers needle penetration force. WK34601, Test Method for Penetration Testing of Needles Used in Surgical Sutures, is under the jurisdiction of Subcommittee F04.33 on Medical/Surgical Instruments.

“No standard currently exists that addresses specifically curved surgical needle penetration testing,” says Eric Hinrichs, principal engineer, ETHICON, and a member of F04. “This type of testing is influenced by the speed of the test, the amount of the needle that passes through the test medium and the characteristics and properties of the test medium utilized.”

Hinrichs notes that having a standard will aid in the comparison of data. “Once a standard is in place, the next step will be to develop an industry-wide medium for the test.”

All interested parties, particularly manufacturers and users of wound closure devices that use curved surgical needles with sutures, are encouraged to join in the development of WK34601.

CONTACT Technical Information: Eric Hinrichs, Ethicon Inc. • Somerville, N.J. • Phone: 908-218-3177 O ASTM Staff: Pat Picariello • Phone: 610-832-9720 O Upcoming Meeting: May 8-11, 2012 • May Committee Week • Phoenix, Ariz.

This article appears in the issue of Standardization News.