ASTM F1079-1987(2008)e1 Standard Specification for Inserted and Noninserted Surgical Scissors《外科镶刃与不镶刃剪的标准规范》.pdf

1、Designation: F 1079 87 (Reapproved 2008)e1Standard 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

2、last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the Department of Defense.e1NOTEEditorial changes were made throughout in J

3、une 2008.1. Scope1.1 This specification covers general workmanship 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: Thi

4、s standard doesnot purport to address all of the safety concerns, 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

5、ASTM Standards:2A 380 Practice for Cleaning, Descaling, and Passivation ofStainless Steel Parts, Equipment, and SystemsE18 Test Methods for Rockwell Hardness of MetallicMaterialsE 92 Test Method for Vickers Hardness of Metallic Mate-rialsE 140 Hardness Conversion Tables for Metals RelationshipAmong

6、Brinell Hardness, Vickers Hardness, RockwellHardness, Superficial 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 Surg

7、ical Instruments3. Terminology3.1 Definitions applicable to 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 in accordance with Specification F

8、899. Inserts shallbe made of stellite or tungsten carbide or other suitablematerial.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). (See Te

9、st Methods E18.) Oppositehalves and inserts shall not vary in hardness by more than 4points on the Rockwell hardness scale (HRC) or equivalent.5.2 PassivationInstruments and instrument componentsshall be passivated after completion of all fabricating andfinishing operations as specified in Practice

10、A 380.5.3 Heat TreatmentThe component parts of the instru-ments shall be heat treated under conditions recommended forthe material used. Typical heat-treatment guidelines and hard-ness values are given in Specification F 899.6. Performance Requirements6.1 Corrosion ResistanceInstruments or instrumen

11、t 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,orTable 3. Clean scissorsto be tested prior to testing. Perform three separate, consecutivetests with each scissors. Each

12、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 thematerial. Each cut shall be made using the scissors in thenormal manner, that is, with the examiners fingers in the fingerrings of the instrumen

13、t, except that no lateral pressure shall be1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.33 on Medical/Surgical Instruments.Current edition approved Feb. 1, 2008. Published March 20

14、08. Originallyapproved in 1987. Last previous edition approved in 2002 as F 1079 87 (2002).2For referenced ASTM 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 Su

15、mmary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.exerted.Any bending or snagging of the test material anywherealong the cut including the distal tips shall be cause forrejection.7. Workmanship, Finish, an

16、d Appearance7.1 Finger RingsThe inside surface of the finger ringsshall be well rounded and polished and comply with therequirements 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 sha

17、ll be ground uniformly to provide a smooth nongrat-ing action.7.4 Pivot ScrewThe 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), cra

18、cks, coarse marks, and processing materials.7.5.2 TypeThe finish shall be 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

19、 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 entirely their own responsibility.This standard is subject to revision at any ti

20、me 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 standardsand should be addressed to ASTM International Headquarters. Your comments will

21、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 Committee on Standards, at the address shown below.This standard is copyrighted by ASTM

22、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 t

23、hrough the ASTM website(www.astm.org).TABLE 2 Testing Materials for Medium 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 UterineScissorsDressin

24、g ScissorsDAPHINELatex rubber sheet 0.009/0.0115 Tonsil ScissorsLatex rubber 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 BandageSciss

25、orsBowel ScissorsDoyen Flesh ScissorsStockinette(JJ-S-746Type I)2 layersLatex rubbersheet0.006/0.010TABLE 1 Testing Materials for Lightweight and Micro, Neuro, andOphthalmologic ScissorsExample of AcceptableTesting MaterialsThickness, in. ExamplesSynthetic (50 % polyester, 50 %cotton)0.007 (1 layer)

26、 Iris ScissorsStrabismus ScissorsStevens ScissorsDissecting 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 the aforementioned materials to test extrafine micro, neuro, and ophthalmologic scissors.F 1079 87 (2008)e12