ASTM_F_1079_-_87_2014.pdf

Designation:F107987(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 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 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 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 ASTM Standards:2A380 Practice for Cleaning,Descaling,and Passivation ofStainless Steel Parts,Equipment,and SystemsE18 Test Methods for Rockwell Hardness of Metallic Ma-terialsE92 Test Method for Vickers Hardness of Metallic Materials(Withdrawn 2010)3E140 Hardness Conversion Tables for Metals RelationshipAmong Brinell Hardness,Vickers Hardness,RockwellHardness,Superficial Hardness,Knoop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 HardnessF899 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 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 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 scale(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 forthe 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 shall comply with thematerial specified in Table 1,Table 2,or Table 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 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 including 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 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 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 Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 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,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(exceptcu