1、Designation:F132591(Reapproved 2008)1Standard Specification forStainless Steel Suture Needle Holders-GeneralWorkmanship Requirements and Corresponding TestMethods1This standard is issued under the fixed designation F1325;the number immediately following the designation indicates the year oforiginal
2、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.1NOTESubsections 3.1.2 and 4.1 were editorially corrected in December 2008.1.Scope1.1
3、This specification covers general workmanship aspectsof stainless steel suture needle holders intended for reuse insurgery.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Test Methods for Rockwell Hardness of Metallic Ma-terialsE92 Test Method for Vickers Hardness of Metallic Materials(Withdrawn 2010)
4、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 F
5、orcepsF1089 Test Method for Corrosion of Surgical Instruments3.Terminology3.1 Definitions:3.1.1 modified working endworking surfaces possessingsuperior hardness characteristics which are either the result ofdepositing various materials on the base metal or the result ofpermanently securing an insert
6、(such as by brazing)to the basemetal.3.1.2 DiscussionThe typical method of modifying theworking end of the suture needle holder is to use jaw inserts orto plasma deposit(flame plate)materials with improved wearcharacteristics such as tungsten carbide or stellite(trade-marked).For the jaw insert meth
7、od,the insert is brazed to thejaw face with a uniform deposit of silver solder which is freeof crevices at all interfaces.For the flame plating method,auniform layer of material is deposited which is 0.004 6 0.001in.thick.3.2 Definitions applicable to stainless steel suture needleholders and the ter
8、ms specified herein,shall be in accordancewith Definitions of Terms F921.4.Materials4.1 All component parts of the instrument other than themodified working end shall be fabricated from martensiticstainless steel type 410,410X,416,420A,420B,420C,420F,420F Mod,and 440B per Specification F899(see Note
9、 1).Themodified working end may be made of stellite(trademarked),tungsten carbide,or other suitable material.NOTE1Free-machining grades of stainless steel are inappropriate foruse due to their lower corrosion resistance and toughness.5.Requirements5.1 Heat treatment and hardness for component parts.
10、5.1.1 Stainless steel component parts of the instrument shallbe heat treated under conditions recommended for the materialused.5.1.2 The Rockwell hardness of an instrument with theworking end not modified shall be 42 HRC to 52 HRC.Instruments where the working end has been modified shallhave a modif
11、ied working surface whose Rockwell hardness isA77 minimum.5.2 Corrosion ResistanceHolders with working ends notmodified shall be subjected to corrosion tests as specified inTest Method F1089.Holders with modified working ends shallbe subject to corrosion tests as specified in Test Method F1089except
12、 for the modifying material.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 Feb.1,2008.Published March 2008.Originallyappro
13、ved in 1991.Last previous edition approved in 2002 as F1325 91(2002).DOI:10.1520/F1325-91R08E01.2For 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 Su
14、mmary 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 6.Performance Requirements6.1 Needle retention testFrom Table 1,select a nee
15、dle,sized for use with the holder being tested.The suture needle,with its axis held perpendicularly to the axis of the jaw shall,upon engagement of the second ratchet of the suture needleholder,show no lateral,rotational,or longitudinal motion whensubjected to a one-half pound pull and a one-inch-po
16、undtorsion.7.Workmanship,Finish,and Appearance7.1 Finish:7.1.1 SurfacesSurfaces of the instrument shall be uni-formly finished and free from burrs,sharp edges,cracks,coarsemarks,and processing materials.7.1.2 TypeThe finish shall be one of the types specified inDefinitions of Terms F921 or as specified by the purchaser.7.2 Workmanship:7.2.1 Finger rings-inside surfaces of the finger rings shall bewell rounded and conform to the requirements of Section 7.1.1.7.2.2 The pivot screw or pin shall be