ASTM F1079-1987(2014) Standard Specification for Inserted and Noninserted Surgical Scissors《外科镶刃和不镶刃剪的标准规格》.pdf

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1、Designation: F1079 87 (Reapproved 2014)Standard Specification forInserted and Noninserted Surgical Scissors1This standard is issued under the fixed designation F1079; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last

2、 revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers general workmanship aspectsof inserted and noninserted stainless steel scissors fabricatedfrom s

3、tainless 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 concerns, if any,associated with its use. It is the responsibility of the user of thisst

4、andard to establish appropriate safety and health practicesand determine the applicability of regulatory limitations priorto use.2. Referenced Documents2.1 ASTM Standards:2A380 Practice for Cleaning, Descaling, and Passivation ofStainless Steel Parts, Equipment, and SystemsE18 Test Methods for Rockw

5、ell Hardness of Metallic Ma-terialsE92 Test Method for Vickers Hardness of Metallic Materials(Withdrawn 2010)3E140 Hardness Conversion Tables for Metals RelationshipAmong Brinell Hardness, Vickers Hardness, RockwellHardness, Superficial Hardness, Knoop Hardness, Sclero-scope Hardness, and Leeb Hardn

6、essF899 Specification for Wrought Stainless Steels for SurgicalInstrumentsF1078 Terminology for Surgical ScissorsInserted andNon-Inserted BladesF1089 Test Method for Corrosion of Surgical Instruments3. Terminology3.1 Definitions applicable to surgical scissors shall be inaccordance with Terminology

7、F1078.4. 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 F899. Inserts shallbe made of stellite or tungsten carbide or other suitablematerial.5. Physical Properties5.1 Rockwell

8、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 Test Methods E18.) Oppositehalves and inserts shall not vary in hardness by more than 4points on the Rockwell hardness sc

9、ale (HRC) or equivalent.5.2 PassivationInstruments and instrument componentsshall be passivated after completion of all fabricating andfinishing operations as specified in Practice A380.5.3 Heat TreatmentThe component parts of the instru-ments shall be heat treated under conditions recommended forth

10、e material used. Typical heat-treatment guidelines and hard-ness values are given in Specification F899.6. Performance Requirements6.1 Corrosion ResistanceInstruments or instrument com-ponents shall be subject to corrosion tests specified in TestMethod F1089.6.2 Cutting AbilityThe test material shal

11、l 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 test shall consist of a nonstop cutalong the distal two-thirds of the blade length using the testmaterial at right angles

12、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 anywherealong the cut incl

13、uding the distal tips shall be cause forrejection.7. Workmanship, Finish, and Appearance7.1 Finger RingsThe inside surface of the finger ringsshall be well rounded and polished and comply with therequirements in 7.5.1.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and

14、Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.33 on Medical/Surgical Instruments.Current edition approved Oct. 1, 2014. Published November 2014. Originallyapproved in 1987. Last previous edition approved in 2008 as F1079 87 (2008)1.DOI: 10.1520/F1079-87R14.2For r

15、eferenced 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 Summary page onthe ASTM website.3The last approved version of this historical standard is reference

16、d onwww.astm.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States17.2 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 groun

17、d 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), cracks, coarse

18、 marks, and processing materials.7.5.2 TypeThe finish shall be one of the types specified inTerminology F1078 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

19、 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 time by the re

20、sponsible 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 receive care

21、ful 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 Internationa

22、l, 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 A

23、STM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 1 Testing Materials for Lightweight and Micro, Neuro, andOphthalmologic ScissorsExample of AcceptableTesti

24、ng 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)Potts-DeMartellJosephLatex rubber sheet 0.009/0.0115Latex rubber sheet 0.004/0.008Wet

25、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.TABLE 2 Testing Materials for Medium Weight ScissorsExample of Acc

26、eptableTesting 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 rubber sheet 0.006/0.010TABLE 3 Te

27、sting 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 rubbersheet0.006/0.010F1079 87 (2014)2