ASTM_F_1026_-_86_2014.pdf

Designation:F102686(Reapproved 2014)Standard Specification forGeneral Workmanship and Performance Measurements ofHemostatic Forceps1This standard is issued under the fixed designation F1026;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 hemostatic forceps fabricated from stainless steel andintended for reuse in surgery.2.Referenced Documents2.1 ASTM Standards:2E18 Test Methods for Rockwell Hardness of Metallic Ma-terialsE92 Test Method for Vickers Hardness of Metallic Materials(Withdrawn 2010)3E140 Hardness Conversion Tables for Metals RelationshipAmong Brinell Hardness,Vickers Hardness,RockwellHardness,Superficial Hardness,Knoop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 SurgicalInstrumentsF921 Terminology Relating to Hemostatic Forceps3.Terminology3.1 Definitions applicable to hemostatic forceps shall be inaccordance with Definitions F921.4.Material4.1 All of the component parts of the instruments shall bemade of martensitic stainless steel of Type 410,410X,416,416MOD,420A,or 420B of Specification F899.5.Physical Requirements5.1 Heat Treatment and Hardness for Component Parts:5.1.1 The component parts of the instruments shall be heattreated under conditions recommended for the material used.Typical heat treating guidelines and hardness values are givenin Specification F899.5.1.2 The hardness of all opposing parts of the sameinstrument shall not vary in hardness by more than 4 units onthe Rockwell Hardness C scale(HRC)or equivalent.(See TestMethods E18.)5.2 PassivationInstruments and instrument componentsshall be passivated after completion of all fabricating andfinishing operations.6.Performance Requirements6.1 Finger RingsInside surfaces shall be well rounded andpolished and shall comply with the requirements in 7.1.6.2 Jaw Serrations and TeethThe serrations and teethshall be of uniform depth and height and well defined toprovide effective gripping.The serrations and teeth shallinterdigitate.The edges of the serrations shall be chamfered.6.3 Box LockThe hemostatic forceps shall be of box lockconstruction,as defined in Definitions F921.The pin,or otherfastening component,shall be permanently secured.The jointperformance of the box lock shall be smooth,of equalresistance,and non-binding when opening or closing theforceps to an included angle of 90 6 5(the lock may belubricated).6.4 ClearanceThe maximum clearance between the maleand female members of the forceps in the lock area shall be 0.4mm(0.015 in.).The clearance is the visible gap that existswhen the instrument is viewed from both the front and sideprofile or end view of the instrument(excluding bevel)(seeFig.1).6.5 RatchetsRatchets shall securely engage at each ratchetposition in a smooth and progressive manner.6.6 Jaw and Ratchet SettingThe jaw tips shall close andinterdigitate when the first ratchet position is engaged,andthere shall be no visible misalignment of the jaws.The jawsshall progressively tighten with each succeeding ratchet en-gagement.Each ratchet position shall hold firmly and releaseeasily.The jaws shall be fully closed and the serrations1This 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 1986.Last previous edition approved in 2008 as F1026 86(2008)1.DOI:10.1520/F1026-86R14.2For 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 interdigitated when the last ratchet is engaged.The jaws shallnot open as the result of engaging any ratchet position.6.7 ElasticityThe instrument by design shall be capable ofpassing the test for elasticity as specified in 8.2.After comple-tion of the test,no visible distortion,cracks,or other visibledamage to the instrument shall be evident.7.Workmanship,Finish,and Appearance7.1 SurfacesThe surfaces of the instrument shall be uni-formly finished and free of burrs,sharp edges,cracks,coarsemarks,and manufacturing materials.7.2 TypeThe finish shall be one of the types defined inDefinitions F921,or as required by the purchaser.8.Test Methods8.1 HardnessHardness shall be determined in accordancewith Test Methods E18 or Test Method E92.Conversion ofVickers har