ASTM F1079-1987(2008) Standard Specification for Inserted and Noninserted Surgical Scissors.pdf

1、Designation: F 1079 87 (Reapproved 2008)Standard Specification forInserted and Noninserted Surgical Scissors1This standard is issued under the fixed designation F 1079; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of la

2、st revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the Department of Defense.1. Scope1.1 This specification covers general work

3、manship aspectsof inserted and noninserted stainless steel scissors fabricatedfrom stainless steel and intended for reuse in surgery.1.2 The following safety hazards caveat pertains only to thetest method described in this specification: This standard doesnot purport to address all of the safety con

4、cerns, if any,associated with its use. It is the responsibility of the user of thisstandard to establish appropriate safety and health practicesand determine the applicability of regulatory limitations priorto use.2. Referenced Documents2.1 ASTM Standards:2A 380 Practice for Cleaning, Descaling, and

5、 Passivation ofStainless Steel Parts, Equipment, and SystemsE 18 Test Methods for Rockwell Hardness of MetallicMaterialsE 92 Test Method for Vickers Hardness of Metallic Mate-rialsE 140 Hardness Conversion Tables for Metals RelationshipAmong Brinell Hardness, Vickers Hardness, RockwellHardness, Supe

6、rficial Hardness, Knoop Hardness, andScleroscope HardnessF 899 Specification for Wrought Stainless Steels for Surgi-cal InstrumentsF 1078 Terminology for Surgical ScissorsInserted andNon-Inserted BladesF 1089 Test Method for Corrosion of Surgical Instruments3. Terminology3.1 Definitions applicable t

7、o surgical scissors shall be inaccordance with Terminology F 1078.4. Material4.1 All the component parts of the instrument shall be madeof martensitic stainless steel type 410, 410K, 416, 420, 420A,and 420B of Specification F 899. Inserts shall be made ofstellite or tungsten carbide or other suitabl

8、e material.5. Physical Properties5.1 Rockwell HardnessThe Rockwell hardness of thescissor halves and inserts shall be within the range of 40 HRCand 58 HRC (approximately equivalent to Vickers hardness530 HV and 670 HV). Opposite halves and inserts shall notvary in hardness by more than 4 points on t

9、he Rockwellhardness scale (HRC) or equivalent.5.2 PassivationInstruments and instrument componentsshall be passivated after completion of all fabricating andfinishing operations as specified in Practice A 380.5.3 Heat TreatmentThe component parts of the instru-ments shall be heat treated under condi

10、tions recommended forthe material used. Typical heat treating guidelines and hardnessvalues are shown in Specification F 899.6. Performance Requirements6.1 Corrosion ResistanceInstruments or instrument com-ponents shall be subject to corrosion tests specified in TestMethod F 1089.6.2 Cutting Ability

11、The test material shall comply with thematerial specified in Table 1, Table 2,orTable 3. Clean scissorsto be tested prior to test. Perform three separate, consecutivetests with each scissor. Each test shall consist of a nonstop cutalong the distal two-thirds of the blade length using the testmateria

12、l at right angles to the threads (if present) of thematerial. Each cut shall be made using the scissors in thenormal manner, that is, with the examiners fingers in the fingerrings of the instrument, except that no lateral pressure shall beexerted.Any bending or snagging of the test material anywhere

13、along the cut including the distal tips shall be cause forrejection.7. Workmanship, Finish, and Appearance7.1 Finger RingsInside surfaces shall be well roundedand polished and comply with the requirements in 7.5.1.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surg

14、ical Materials and Devices and is the direct responsibility ofSubcommittee F04.33 on Medical/Surgical Instruments.Current edition approved Feb. 1, 2008. Published March 2008. Originallyapproved in 1987. Last previous edition approved in 2002 as F 1079 87 (2002).2For referenced ASTM standards, visit

15、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.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959

16、, United States.7.2 JointThe instrument shall have a smooth moving joint(ride) and shall close and open easily.7.3 Cutting EdgesInside surfaces of blades and cuttingedges shall be ground uniformly to provide a smooth nongrat-ing action.7.4 Pivot ScrewThe pivot screw shall be permanently set,peened,

17、and ground flush or peened over.7.5 Finish:7.5.1 SurfacesThe surfaces of the instrument shall beuniformly finished and free from burrs, sharp edges (exceptcutting edges), cracks, coarse marks, and processing materials.7.5.2 TypeThe finish shall be one of the types specified inTerminology F 1078 or a

18、s specified by the purchaser.8. Keywords8.1 instruments; stainless steelsurgical applicationsASTM 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

19、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

20、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

21、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

22、 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).TABLE 2 Testing Materials for Medium Weight ScissorsExample of AcceptableTesting Materia

23、lsThickness, in. ExamplesCoarse flannel cotton 0.025/0.035(1 layer)Mayo ScissorsMetzenbaumScissorsNail ScissorsStockinette (JJ-S-746Type I)1 layer Sims UterineScissorsDressing ScissorsDAPHINELatex rubber sheet 0.009/0.0115 Tonsil ScissorsLatex rubber sheet 0.006/0.010TABLE 3 Testing Materials for He

24、avyweight ScissorsExample of AcceptableTesting MaterialsThickness, in. ExamplesCoarse cottonflannel0.050/0.070(2 layers of0.025/0.035)Lister BandageScissorsSmith BandageScissorsBowel ScissorsDoyen Flesh ScissorsStockinette(JJ-S-746Type I)2 layersLatex rubbersheet0.006/0.010TABLE 1 Testing Materials

25、for Lightweight and Micro, Neuro, andOphthalmologic ScissorsExample of AcceptableTesting MaterialsThickness, in. ExamplesSynthetic (50 % polyester, 50 %cotton)0.007 (1 layer) Iris ScissorsStrabismus ScissorsStevens ScissorsDissecting ScissorsSynthetic (65 % polyester, 35 %cotton)0.006/0.007 (Kilner)

26、Potts-DeMartellJosephLatex rubber sheet 0.009/0.0115Latex rubber sheet 0.004/0.008Wet facial tissue paperA(2 layers)N/ASilicone tubingA0.030 ID, 0.065 ODSuturetwist polyester fiberA0.025 (G-207)AThis material may also be used with the aforementioned materials to test extrafine micro, neuro, and ophthalmologic scissors.F 1079 87 (2008)2