ASTM F1874-1998(2004) Standard Test Method for Bend Testing of Needles Used in Surgical Sutures《外科缝合用针的弯曲试验的标准试验方法》.pdf

1、Designation: F 1874 98 (Reapproved 2004)Standard Test Method forBend Testing of Needles Used in Surgical Sutures1This standard is issued under the fixed designation F 1874; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year o

2、f last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method describes the procedure for bendtesting needles used for the placement of surgical sutures.1.2 Thi

3、s standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Document

4、s2.1 ASTM Standards:F 1840 Terminology for Surgical Suture Needles23. Terminology3.1 DefinitionsDefinitions of terms used in this testmethod are in accordance with Terminology F 1840.3.2 Definitions of Terms Specific to This Standard:3.2.1 needle test gripping location, nfor test methods, theneedle

5、will be clamped two-thirds of the distance back from thepoint of the needle. Since the needle will deform during thebend test, the needle test gripping location only applies to anunbent needle.3.2.2 test chord length, nthe straight line distance fromthe center of rotation of the needle in the test f

6、ixture to theinitial point of contact with the bending platform or knife edge.4. Summary of Test Method4.1 Surgical needles are grasped approximately two-thirdsof the distance from the point of the needle, then bent againsta knife edge or platform. The force deflection data obtainedfrom the test wil

7、l be used to calculate the yield bend momentand the maximum bend moment.4.2 The decision to use a knife edge or a platform for thebending surface will be determined by the equipment available.5. Significance and Use5.1 This test method provides a means of assessing the yieldmoment and maximum moment

8、 of a surgical needle.5.2 The needle is bent against a platform or knife edge, andit is bent at the approximate location where a pair of needleholders would grip it. This simulates the actual bending of aneedle while in surgical use.6. Apparatus6.1 Clamping FixtureA device to firmly clamp and rotate

9、the needle.6.2 Bending PlatformThe surface on which the curvedneedle will exert force during the test. The bending platformwill have its top surface located along the horizontal axis of thecenter of rotation of the clamping fixture.6.3 Knife EdgeThe knife edge will be placed parallel tothe centerlin

10、e of rotation to provide a single point contact forreading the torque generated by the needle.6.4 Data Collection SystemThe data will be collected as afunction of rotational angle.6.5 Rotation SpeedThe clamping fixture must be rotatedat a continuous and constant speed. This speed will be less than30

11、/s.7. Sampling7.1 A sample size of no less than five needles shall be used.8. Procedure (see Fig. 1)8.1 Securely clamp the needle into the clamping fixture at aposition approximately two-thirds of the distance back fromthe tip of the needle.8.2 Rotate the clamping fixture forward until the needletou

12、ches the bending platform or knife edge. Continue rotatingthe clamping fixture through a sufficient angle to generate therequired data. While the needle is bending, collect the bendingforce data as a function of the bend angle.9. Calculation (see Fig. 2)9.1 Data will be reported as a moment versus d

13、egrees ofrotation. Units will be reported.9.2 Yield Bend MomentUsing the graph obtained duringthe needle bend test, calculate the initial slope of the graph.Draw a line with the same slope through the 2 offset on the1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surg

14、ical Materials and Devices and is the direct responsibility of SubcommitteeF04.33 on Medical/Surgical Instruments.Current edition approved May 1, 2004. Published May 2004. Originallyapproved in 1998. Last previous edition approved in 1998 as F 1874 98.2For referenced ASTM standards, visit the ASTM w

15、ebsite, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United S

16、tates.degree axis. Read the bending moment at the point where the2 offset slope crosses the data line. This is the yield bendmoment.9.3 Yield Bend AngleRead the angle at the point where the2 offset slope line crosses the data line.9.4 Maximum Bend MomentThe maximum bend momentis the largest bending

17、moment achieved by the needle duringthe bend test.10. Report10.1 Include the following information:10.1.1 Sample identification, test conditions, and apparatus.10.1.2 Test chord length.10.1.3 Yield bend moment.10.1.4 Yield bend angle.FIG. 1 Sample Bend TestsFIG. 2 Bend Test Data CurveF 1874 98 (2004

18、)210.1.5 Maximum bend moment (angle at which it wasachieved should be reported).11. Precision and Bias11.1 PrecisionThe precision of the results of this testmethod are dependent on the equipment selected.11.2 BiasNo standard material has been selected forreference; therefore, bias for this test meth

19、od cannot bedetermined.12. Keywords12.1 bend test; needle; strength; surgical; sutureAPPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 It is understood that the needle contact with theplatform or knife edge will change as the needle is deformedduring the test, effecting the value of the test chord

20、 length. Thisis an agreed upon convention by the users of the test.X1.2 It is understood that the test chord length will be largeenough to prevent shear effect on the test and allow measure-ment of bend moment.X1.3 When comparing results, it is understood that the testchord lengths will be the same.

21、ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are

22、 entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standar

23、dsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committ

24、ee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F 1874 98 (2004)3