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Significance and Use
5.1 This test method provides a means of assessing the penetration force of a surgical needle through the chosen media.
5.2 The needle is passed through a chosen medium at a chosen speed and path which applies a force on the load cell that reflects the needle’s resistance to penetration as a function of its shape and coating.
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.
1.6 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
F1840 Terminology for Surgical Suture Needles
ICS Number Code 11.040.30 (Surgical instruments and materials)
UNSPSC Code 42292904(Surgical suture or wire passers or related products)