ASTM F1079-1987(2002) Standard Specification for Inserted and Noninserted Surgical Scissors《外科镶刃与不镶刃剪标准规范》.pdf

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1、Designation: F 1079 87 (Reapproved 2002)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:A 380 Practice for Cleaning, Descaling, and

5、Passivation ofStainless Steel Parts, Equipment, and Systems2E 18 Test Methods for Rockwell Hardness and RockwellSuperficial Hardness of Metallic Materials3E 92 Test Method for Vickers Hardness of Metallic Mate-rials3E 140 Hardness Conversion Tables for Metals3F 899 Specification for Stainless Steels

6、 for Surgical Instru-ments4F 1078 Terminology for Surgical ScissorsInserted andNon-Inserted Blades4F 1089 Test Method for Corrosion of Surgical Instruments43. Terminology3.1 Definitions applicable to surgical scissors shall be inaccordance with Terminology F 1078.4. Material4.1 All the component par

7、ts 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 suitable material.5. Physical Properties5.1 Rockwell HardnessThe Rockwell hardness of thescissor halves and i

8、nserts 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 the Rockwellhardness scale (HRC) or equivalent.5.2 PassivationInstruments and instrument componentsshal

9、l 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 conditions recommended forthe material used. Typical heat treating guidelines and hardnessvalues are shown

10、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 AbilityThe test material shall comply with thematerial specified in Table 1, Table 2, or Table 3. Clean sciss

11、orsto 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 testmaterial at right angles to the threads (if present) of the1This specification is under the jurisdiction of

12、 ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F 04.33 on Medical/Surgical Instruments.Current edition approved Sept. 25, 1987. Published November 1987.2Annual Book of ASTM Standards, Vol 01.03.3Annual Book of ASTM Standards, Vol 03.0

13、1.4Annual Book of ASTM Standards, Vol 13.01.TABLE 1 Testing Materials for Lightweight and Micro, Neuro, andOphthalmologic ScissorsExample of AcceptableTesting MaterialsThickness, in. ExamplesSynthetic (50 % polyester, 50 %cotton)0.007 (1 layer) Iris ScissorsStrabismus ScissorsStevens ScissorsDissect

14、ing ScissorsSynthetic (65 % polyester, 35 %cotton)0.006/0.007 (Kilner)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

15、 the aforementioned materials to test extrafine micro, neuro, and ophthalmologic scissors.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.material. Each cut shall be made using the scissors in thenormal manner, that is, with the exam

16、iners fingers in the fingerrings of the instrument, except that no lateral pressure shall beexerted. Any bending or snagging of the test material anywherealong the cut including the distal tips shall be cause forrejection.7. Workmanship, Finish, and Appearance7.1 Finger RingsInside surfaces shall be

17、 well roundedand polished and comply with the requirements in 7.5.1.7.2 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 Sc

18、rewThe pivot screw shall be permanently set,peened, 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

19、one of the types specified inTerminology F 1078 or as 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

20、this standard are expressly advised that determination 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

21、years andif not revised, either reapproved or withdrawn. 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 com

22、mittee, which you may attend. If you feel that your 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 1

23、9428-2959,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).TABLE 2 Testing Materials for Medium

24、 Weight ScissorsExample of AcceptableTesting MaterialsThickness, 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 rubb

25、er sheet 0.006/0.010TABLE 3 Testing Materials for Heavyweight 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 rubbersheet0.006/0.010F 1079 87 (2002)2