1、Designation: F 1613 95 (Reapproved 2008)e1Standard Specification forSurgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)1This standard is issued under the fixed designation F 1613; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, t
2、he 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.e1NOTEEditorial changes were made throughout in June 2008.1. Scope1.1 This specification covers general workmanship asp
3、ectsof 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. Ref
4、erenced Documents2.1 ASTM Standards:2E18 Test Methods for Rockwell Hardness of MetallicMaterialsE 92 Test Method for Vickers Hardness of Metallic Mate-rialsE 140 Hardness Conversion Tables for Metals RelationshipAmong Brinell Hardness, Vickers Hardness, RockwellHardness, Superficial Hardness, Knoop
5、Hardness, andScleroscope HardnessF 899 Specification for Wrought Stainless Steels for Surgi-cal InstrumentsF 921 Terminology Relating to Hemostatic ForcepsF 1026 Specification for General Workmanship and Perfor-mance Measurements of Hemostatic ForcepsF 1089 Test Method for Corrosion of Surgical Inst
6、rumentsF 1638 Terminology for Surgical Tissue/Dressing/Pick-UpForceps (Thumb-Type)3. Terminology3.1 DefinitionsDefinitions shall be in accordance withTerminology F 1638.3.1.1 modified working endsworking surfaces possessingsuperior hardness characteristics that are the result of eitherdepositing var
7、ious 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 F 899. The modified working ends may
8、 beof stellite, tungsten carbide, or other suitable material.5. Requirements 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 inst
9、rument 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 subjectedto corrosion tests as specified in Test Method F 1089.5.3
10、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 inDefinitions F 921 or as specified by the purchaser.5.4 Workmanship:5.4.1 SymmetryExcl
11、uding 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 Hol
12、e:5.5.1 The guide pin shall pass through the guide pin holewithout binding.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
13、Feb. 1, 2008. Published March 2008. Originallyapproved in 1995. Last previous edition approved in 2002 as F 1613 95 (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, re
14、fer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5.5.2 The guide pin length shall not protrude past theoutside surface of the guide pin hole when the forceps tipscome in co
15、ntact.NOTE 1Guide 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)
16、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 th
17、einstrument.NOTE 2This specification is not intended to cover delicate tissueforceps such as those used in microsurgery or neurosurgery.NOTE 3Typical methods of modifying the working end of the forcepsis to use jaw inserts or to plasma deposit (flame plate) materials withimproved wear characteristic
18、s such as tungsten carbide or stellite. For thejaw insert methods, the insert is brazed to the jaw face with a uniformdeposit of silver solder that is free of crevices at all interfaces. For theflame plating method, a uniform layer of material that is 0.004 6 0.001 in.(0.1 6 0.03 mm) thick is deposi
19、ted.ASTM International takes no position respecting the validity of any patent rights 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,
20、 are entirely their own responsibility.This standard is subject to revision at any time 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 sta
21、ndardsand should be addressed to ASTM International Headquarters. Your comments will 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 Com
22、mittee on Standards, at the address shown below.This standard is copyrighted by ASTM 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 through the ASTM website(www.astm.org).F 1613 95 (2008)e12
