ASTM F1613-1995(2008) Standard Specification for Surgical Tissue Dressing Pick-Up Forceps (Thumb Type).pdf

1、Designation: F 1613 95 (Reapproved 2008)Standard 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, the

2、 year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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

3、(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:2E 18 Test Methods for

4、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 Hardness, andScleroscope HardnessF 899 Specification for W

5、rought 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 InstrumentsF 1638 Terminology for Surgical Tissue/Dressing/Pic

6、k-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 various materials on the base metal or securing aninsert perm

7、anently (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 beof stellite, tungsten carbide, or other suitable materi

8、al.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 instrument withthe working end not modified shall be 4049 HRC

9、afterappropriate processing. Instruments in which the working endhas been modified shall have an HRC of A77.5.2 Corrosion ResistanceInstruments shall be subjectedto corrosion tests as specified in Test Method F 1089.5.3 Finish:5.3.1 SurfacesSurfaces of the instruments shall be uni-formly finished an

10、d 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 SymmetryExcluding functional differences, bothforceps halves shall be symmetrical.5.4.2 Teet

11、hTeeth shall be well formed, uniform in depthand spacing, and mesh without binding, unless designedotherwise.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 Ins

12、truments.Current edition approved 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 AS

13、TMStandards volume information, refer 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.5.4.3 Handle SerrationsHandle serrations shall be uni-form in depth and spacing.5.5 Guide

14、 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.NOTE 1Guide pin/guide pin holes are generally used on forceps 712in. (191

15、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

16、 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 location of marking shall be on a suitable surface ofthe instrument.NOTE 2This specification is not intended to cover delicate tissu

17、eforceps 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 characteristics such as tungsten carbide or stellite. For thejaw insert methods, the inser

18、t 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 is deposited that is 0.0046 0.001 in. (0.1 6 0.03 mm) thick.ASTM International takes no position respecting the validity of any pate

19、nt 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, are entirely their own responsibility.This standard is subject to revision

20、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 standardsand should be addressed to ASTM International Headquarters. Your comme

21、nts 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 Committee on Standards, at the address shown below.This standard is copyrighted

22、 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)2