ASTM_F_1613_-_95_2016.pdf

Designation:F161395(Reapproved 2016)Standard Specification forSurgical Tissue/Dressing/Pick-Up Forceps(Thumb Type)1This standard is issued under the fixed designation F1613;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 spring-action,tissue,dressing,or pick-up forceps(thumb-type)intended for the retraction,grasping,or dissection oftissue during surgical procedures.1.2 The values stated in inch-pound units are to be regardedas the standard.The values given in parentheses are forinformation only.2.Referenced Documents2.1 ASTM Standards:2E18 Test Methods for Rockwell Hardness of Metallic Ma-terialsE92 Test Methods for Vickers Hardness and Knoop Hard-ness of Metallic MaterialsE140 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 ForcepsF1026 Specification for General Workmanship and Perfor-mance Measurements of Hemostatic ForcepsF1089 Test Method for Corrosion of Surgical InstrumentsF1638 Terminology for Surgical Tissue/Dressing/Pick-UpForceps(Thumb-Type)3.Terminology3.1 Definitions:3.1.1 Definitions shall be in accordance with TerminologyF1638.3.1.2 modified working endsworking surfaces possessingsuperior hardness characteristics that are the result of eitherdepositing various materials on the base metal or securing aninsert permanently(such as by brazing)to the base metal(seeNote 3).4.Material4.1 All component parts of the instrument shall be fabri-cated from Class 4 martensitic stainless steel in accordancewith Specification F899.The modified working ends may be ofstellite,tungsten carbide,or other suitable material.5.Requirements5.1 Heat Treatment and Hardness for Component Parts:5.1.1 The stainless steel component parts shall be heattreated under conditions recommended for the material used.5.1.2 The Rockwell hardness(HRC)of the instrument withthe working end not modified shall be 4049 HRC(see TestMethods E18)after appropriate processing.Instruments inwhich the working end has been modified shall have an HRCof A77.5.2 Corrosion ResistanceInstruments shall be subjected tocorrosion tests as specified in Test Method F1089.5.3 Finish:5.3.1 SurfacesSurfaces of the instruments shall be uni-formly finished and free of burrs,sharp edges,cracks,coarsemarks,and processing materials.5.3.2 TypeThe finish shall be one of the types specified inTerminology F921 or as specified by the purchaser.5.4 Workmanship:5.4.1 SymmetryExcluding functional differences,bothforceps halves shall be symmetrical.5.4.2 TeethTeeth shall be well formed,uniform in depthand spacing,and mesh without binding,unless designedotherwise.5.4.3 Handle SerrationsHandle serrations shall be uni-form in depth and spacing.5.5 Guide Pin and Guide Pin Hole:5.5.1 The guide pin shall pass through the guide pin holewithout binding.5.5.2 The guide pin length shall not protrude past theoutside surface of the guide pin hole when the forceps tipscome in contact.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.1,2016.Published October 2016.Originallyapproved in 1995.Last previous edition approved in 2008 as F1613 95(2008)1.DOI:10.1520/F1613-95R16.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 NOTE1Guide pin/guide pin holes are generally used on forceps 712in.(191 mm)or longer.6.Performance6.1 AlignmentScissoring shall be 0.015 in.(0.38 mm)orless upon closure.7.Marking and Labeling7.1 All marking and labeling shall be legible.7.2 The instruments shall bear the following:(1)the manu-facturers(or contractors)name or registered trademark;(2)the country of origin(when the instrument is not manufacturedin the United States);and(3)other markings,as required,bythe purchaser or the manufacturer(contractor).7.3 The marking shall be located on a suitable surface of theinstrument.NOTE2This specification is not intended to cover delicate tissueforceps such as those used in microsurgery or neurosurgery.NOTE3Typical methods of modifying the working end of the forcepsis to use jaw inserts or to plasma deposit(flame plate)materials withimproved wear characteristics suc