1、Designation: F 1325 91 (Reapproved 2008)1Standard Specification forStainless Steel Suture Needle Holders-GeneralWorkmanship Requirements and Corresponding TestMethods1This standard is issued under the fixed designation F 1325; the number immediately following the designation indicates the year ofori
2、ginal 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.This standard has been approved for use by agencies of the Department of D
3、efense.1NOTESubsections 3.1.2 and 4.1 were editorially corrected in December 2008.1. Scope1.1 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 o
4、f MetallicMaterialsE92 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 Wrought Stainless Ste
5、els for Surgi-cal InstrumentsF 921 Terminology Relating to Hemostatic ForcepsF 1089 Test Method for Corrosion of Surgical Instruments3. Terminology3.1 Definition:3.1.1 modified working endworking surfaces possessingsuperior hardness characteristics which are either the result ofdepositing various ma
6、terials on the base metal or the result ofpermanently securing an insert (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 wearcharacteristic
7、s such as tungsten carbide or stellite (trade-marked). For the jaw insert method, 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. th
8、ick.3.2 Definitions applicable to stainless steel suture needleholders and the terms specified herein, shall be in accordancewith Definitions of Terms F 921.4. Materials4.1 All component parts of the instrument other than themodified working end shall be fabricated from martensiticstainless steel ty
9、pe 410, 410X, 416, 420A, 420B, 420C, 420F,420F Mod, and 440B per Specification F 899 (see Note 1). Themodified working end may be made of stellite (trademarked),tungsten carbide, or other suitable material.NOTE 1Free-machining grades of stainless steel are inappropriate foruse due to their lower cor
10、rosion resistance and toughness.5. Requirements5.1 Heat treatment and hardness for component parts.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 modif
11、ied shall be 42 HRC to 52 HRC.Instruments where the working end has been modified shallhave a modified 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 F 1089. Holders
12、with modified working ends shall1This 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. Origina
13、llyapproved in 1991. Last previous edition approved in 2002 as F 1325 91 (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, refer to the standards Document Summary page
14、onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.be subject to corrosion tests as specified in Test Method F 1089except for the modifying material.6. Performance Requirements6.1 Needle retention testFrom Table 1, se
15、lect a needle,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
16、 a one-inch-poundtorsion.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 Te
17、rms F 921 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 permanently setpeened, and flush.ASTM International takes no position respecti
18、ng 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, are entirely their own responsibility.This stand
19、ard 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 standardsand should be addressed to ASTM Internation
20、al 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 Committee on Standards, at the address shown below.T
21、his 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
22、), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).TABLE 1 Suture/Needle/Holder RelationshipSuture NeedleHolderMost CommonUseRecommendedTeethPerSquare InchCompatibleSuture Size PerUSPACorrespondingWire Size(Diameter)of NeedleDebakey 7 thru 12 in. vascular andvalve2500 02-00.16
23、 in.0.140.035 in.0.24Hufnagel 8 thru 10 in. replacement 2500 3-04-00.0100.0080.0240.015WebsterHegar-MayoBrowncoronarybypass3500 orsmooth5-06-07-00.0060.0040.0030.0150.0090.009Castrovieijo microsurgery smooth 8-09-00.0020.00150.0060.006Kalt smooth 10-0 0.0008 0.006AMean average of USP absorbable and non-absorbable and Suture size averages.F 1325 91 (2008)12
