ASTM F3014-2014 Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures《外科缝合针穿透试验的标准试验方法》.pdf

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1、Designation: F3014 14Standard Test Method forPenetration Testing of Needles Used in Surgical Sutures1This standard is issued under the fixed designation F3014; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revisi

2、on. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONThe purpose of this test method is to provide a common method for fixturing and measuring thepenetration force of a surgical need

3、le. Most surgical needles are coated to facilitate passage throughtissue. This coating needs to be both lubricious and durable. The lubricity of the coating acts to lowerthe penetration force, while the durability of the coating maintains the needles ability to pass throughtissue multiple times with

4、 minimum increase in penetration force. It has been observed that, when acoating is found to be more lubricious, that coating is often less durable. Likewise, when a coating isfound to be more durable, that coating is often less lubricious. Comparative measurements of lubricityand durability can pro

5、vide an expectation of how the coated needle may perform during actual use.This standard does not presently address the testing medium. Test medium will be addressed in thenext phase of this test method development. However, this test method does require certain mediumcharacteristics to be identifie

6、d.1. Scope1.1 This test method describes the procedure for penetrationtesting sharp and blunt needles used for the placement ofsurgical sutures. It only describes the test procedures (Phase 1)and does not define a test medium at this time. Test media willbe address in the next phase (Phase 2) of thi

7、s test methodsevolution.1.2 This test method applies to straight and curved surgicalneedles.1.3 This test method does not intend to address the value ofthe test with respect to actual conditions of use.1.4 In this test method, it is assumed the needles used forthis test have passed all applicable qu

8、ality standards and haveno physical malformation that would inappropriately influencethe test results.1.5 This test method quantifies the force required for aneedle to pass through a medium and its ability to do somultiple times.1.6 UnitsThe values stated in either SI units or inch-pound units are t

9、o be regarded separately as standard. Thevalues 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 noncon-formance with the standard.1.7 This standard does not purport to address all o

10、f 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 Documents2.1 ASTM Standards:2E122 Practice for Calcu

11、lating Sample Size to Estimate, WithSpecified Precision, the Average for a Characteristic of aLot or ProcessF1840 Terminology for Surgical Suture Needles3. Terminology3.1 DefinitionsTerms used in this test method are inaccordance with Terminology F1840.3.2 Definitions of Terms Specific to This Stand

12、ard:3.2.1 compound curved surgical needle, nneedle havingmore than one radius of curvature associated with the shape ofthe needle.3.2.2 needle test gripping location, narea in front of theattachment zone or tangent portion of the needle where theneedle will be clamped/secured in the test fixture.1Th

13、is test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.33 on Medical/Surgical Instruments.Current edition approved March 1, 2014. Published April 2014. DOI: 10.1520/F3014-14.2For referenced ASTM

14、standards, visit the ASTM website, 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.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocke

15、n, PA 19428-2959. United States13.2.2.1 Discussion3.2.2 can be exempt for exceptionallysmall needles.4. Summary of Test Method4.1 Securely clamp the needle into the clamping fixture in auniform area in front of the attachment zone or tangent portionof the needle, distal to the needle point. This is

16、referred to asthe needle test gripping location, such that the needle move-ment is restricted.4.1.1 The needle shall be held so that the needle passesthrough the medium perpendicular to the test medium.4.2 The clamping fixture is rotated forward to commencepassing the needle through the media accord

17、ing to Table 1 orTable 2, as applicable.4.3 As the needle penetrates and passes through the mediumat 90, data about the force needed to penetrate the medium iscontinuously collected.5. Significance and Use5.1 This test method provides a means of assessing thepenetration force of a surgical needle th

18、rough the chosenmedia.5.2 The needle is passed through a chosen medium at achosen speed and path which applies a force on the load cellthat reflects the needles resistance to penetration as a functionof its shape and coating.6. ApparatusNOTE 1Two methods of testing are possible for curved surgicalne

19、edlesrotational, based on the rotational speed of the sample, andlinear, based on the linear speed of the sample. Either method may beused. The method selected shall be indicated in any use of the datagenerated. The data generated by these methods cannot be compared toeach other. Only like method co

20、mparisons shall be made.6.1 Clamping FixtureA device to clamp the surgicalneedle firmly.6.2 Data Collection SystemThe data shall be collected asa function of force.6.3 Rotational Speed for a Curved Surgical NeedleTheneedle-clamping fixture shall be rotated at a continuous andconstant speed of 4 6 2/

21、s.6.4 Linear Speed for a Straight Surgical NeedleTheneedle-clamping fixture shall move at a continuous and con-stant speed. The minimum speed shall be 10.0 cm/min (4in./min). The maximum speed shall be 30.5 cm/min (12in./min) unless a greater test speed is required as a function ofuse.6.5 Linear Spe

22、ed for a Curved Surgical NeedleTheneedle-clamping fixture shall move at a continuous and con-stant speed. The minimum speed shall be 10.0 cm/min (4in./min). The maximum speed shall be 30.5 cm/min (12in./min).6.5.1 Speed can be set to address a special use of the needle.7. Sampling7.1 There should be

23、 a minimum of ten penetrations perneedle. However, the actual number of penetrations may bemore to reflect intended use.7.2 For statistical purposes, a minimum of 30 needles isrecommended.8. ProcedureNOTE 2Accurate fixturing is important. The greater the number ofdegrees the needle is tested through

24、, the greater the chance for a fixturingerror to be introduced to the test.8.1 Curved Surgical Needle:8.1.1 The needle shall be clamped in a uniform area in frontof the attachment zone or tangent portion of the needle, distalto the needle point.8.1.2 Always check the needle before and after each pen

25、-etration to ensure the needle has not moved in the fixture andis properly positioned.8.1.3 The portion of the needle that is behind the fixture, orthe point at which the needle is held may be cut to avoid theneedle hitting the test medium. This would be necessary for 5/8circle needles or a needle w

26、ith a very large radius (see Fig. 1).8.1.4 The needle shall pass through a test medium at auniform speed such that the needle passes through the mediumaccording to Table 1.8.1.4.1 Refer to Table 1 for testing ranges.8.1.5 The needle shall penetrate the medium, at minimum,to the values listed in Tabl

27、e 1 as long as the value contains thefull body diameter of the needle. Refer to Fig. 2.8.1.6 The needle shall pass through the test media such thatthe needles major axis is followed throughout the test.8.1.7 Upon completion of the penetration pass, move theneedle or the medium to an unpenetrated sur

28、face beforeinitiating the next penetration test. This distance should be atminimum twice the wire diameter of the test sample.NOTE 3Each penetration performed shall be in an unadulteratedportion of the test medium. If a needle does pass through a hole made bya previous penetration, that needle shall

29、 be discarded along with the testfindings and noted accordingly.8.2 Straight Surgical Needle:8.2.1 The needle shall be clamped in a uniform area in frontof the attachment zone.8.2.2 The needle shall pass through a test medium at auniform speed.TABLE 1 Curved Surgical Needle Testing RangesNeedleCurva

30、tureEquivalentRange ()ApproximateRotation ()1/4 70 to 115 453/8 116 to 155 451/2 156 to 200 60A5/8 201 to 245 60AALess than 60 of rotation is acceptable provided that the entire point and a portionof the full body diameter have fully passed through the medium.TABLE 2 Straight Surgical Needle Testing

31、 RangesOverall NeedleLengthApproximate PercentLength of Testing(before Cutting, if Applicable)5 to 152 mm 30153 mm and longer 30F3014 1428.2.3 The needle should penetrate the medium, at minimum,to the values listed in Table 2 as long as the value is, as aminimum, equal to the body diameter of the ne

32、edle. Refer toFig. 3.8.2.4 The needle shall be perpendicular to the surface of themedium throughout the test.NOTE 4The needle may be reduced in length to accommodate the testequipment as long as the reduction allows for full body testing of theneedle.8.2.5 Upon completion of the penetration pass, mo

33、ve theneedle or medium to an unpenetrated portion of the mediumbefore initiating the next penetration.NOTE 5Each penetration performed shall be in an unadulteratedportion of the test medium. If a needle does pass through a hole made bya previous penetration, that needle shall be discarded along with

34、 the testfindings and noted accordingly.8.3 Compound Curved Surgical NeedleIt is acceptable totest only the primary curve on multiple curved needles. This istypically the curve associated with the point.8.4 Test MediumThe medium shall be held firmly andsupported sufficiently to minimize deflection (

35、tenting).8.5 Test Fixture:8.5.1 The aperture underneath the area of penetration mayrange between 3 and 19 mm (0.120 and 0.750 in.) in diameteror dimension. The aperture opening beneath the medium shallbe designed to minimize or control tenting of the mediumduring testing.8.5.2 A smaller needle-clamp

36、ing fixture may be necessaryto allow for smaller needles to be tested. This may be necessaryas the fixture for large needles may be too large or distort theFIG. 1 Representation of Degrees of CurvatureFIG. 2 Correct PenetrationFIG. 3 Straight Needle PenetrationF3014 143needles curvature, thus requir

37、ing a smaller needle holder,which would require a smaller medium holder.8.6 Data AcquisitionData acquisition should be a mini-mum of 150 Hz for data collection.8.7 Environment:8.7.1 Room temperature, 22 6 2C.8.7.2 Relative humidity, 70 %.9. Calculation9.1 Data shall be reported as force in Newtons.

38、Grams-forcemay be used as an alternative measure if it is deemedappropriate for the needle being tested.10. Report10.1 Include the following information:10.1.1 Sample identification, test conditions, and apparatus;10.1.2 Test medium and lot number, if applicable;10.1.3 Maximum force per complete pen

39、etration;10.1.4 Average force for each penetration or pass, if testingmultiple needles;10.1.5 Maximum and minimum force (that is, the range offorce) for each penetration repetition, if testing multipleneedles;10.1.6 Test date and test technician;10.1.7 Test speed and test approach (linear or rotatio

40、nal);and10.1.8 Medium thickness.11. Precision and Bias11.1 PrecisionThe precision of the results of this testmethod is dependent on the equipment selected.11.2 BiasNo standard material has been selected forreference; therefore, bias for this test method cannot bedetermined.12. Keywords12.1 curved su

41、rgical needle force; load cell; needle; pen-etration; speed; straight surgical needle; sutureASTM 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 determinati

42、on of the validity of any such patent rights, and the riskof infringement of such rights, are 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 withdr

43、awn. Your comments are invited either for revision of this standard or for additional standardsand 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

44、comments have not received a fair hearing you shouldmake your views known to the ASTM Committee 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

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