1.1 This test method describes the procedure for penetration testing sharp and blunt needles used for the placement of surgical sutures. It only describes the test procedures (Phase 1) and does not define a test medium at this time. Test media will be address in the next phase (Phase 2) of this test method’s evolution.
1.2 This test method applies to straight and curved surgical needles.
1.3 This test method does not intend to address the value of the test with respect to actual conditions of use.
1.4 In this test method, it is assumed the needles used for this test have passed all applicable quality standards and have no physical malformation that would inappropriately influence the test results.
1.5 This test method quantifies the force required for a needle to pass through a medium and its ability to do so multiple times.