ASTM F1325-1991(2002) Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods《不锈钢缝合用针托 一般技术要求和通信试验方法》.pdf

1、Designation: F 1325 91 (Reapproved 2002)Standard 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 oforig

2、inal adoption or, in the case of revision, the 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.This standard has been approved for use by agencies of the Department of D

3、efense.1. Scope1.1 This specification covers general workmanship aspectsof stainless steel suture needle holders intended for reuse insurgery.2. Referenced Documents2.1 ASTM Standards:E 18 Test Methods for Rockwell Hardness and RockwellSuperficial Hardness of Metallic Materials2E 92 Test Method for

4、Vickers Hardness of Metallic Mate-rials2E 140 Hardness Conversion Tables for Metals2F 899 Specification for Stainless Steels for Surgical Instru-ments3F 921 Definitions of Terms Relating to Hemostatic Forceps3F 1089 Test Method for Corrosion of Surgical Instruments33. Terminology3.1 Definition:3.1.1

5、 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 (such as by brazing) to the basemetal.3.1.2 DiscussionThe typical method of modifying theworki

6、ng 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. For the jawinsert method, the insert is brazed to the jaw face with auniform deposit of silver solder which is free of crevices

7、 at allinterfaces. For the flame plating method, a uniform layer ofmaterial is deposited which is 0.004 6 0.001 in. thick.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 compo

8、nent 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 F 899 (see Note 1). Themodified working end may be made of stellite, tungstencarbide, or other suitable

9、 material.NOTE 1Free-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.5.1.1 Stainless steel component parts of the instrument shallbe heat treated under conditions rec

10、ommended 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 modified working surface whose Rockwell hardness isA77 minimum.5.2 Corrosion ResistanceHolders with wo

11、rking ends notmodified shall be subjected to corrosion tests as specified inTest Method F 1089. Holders with modified working ends shallbe subject to corrosion tests as specified in Test Method F 1089except for the modifying material.6. Performance Requirements6.1 Needle retention testFrom Table 1,

12、select 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 a

13、nd a one-inch-poundtorsion.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 April 15, 1991. Published June 1991.2Annual Book

14、 of ASTM Standards, Vol 03.01.3Annual Book of ASTM Standards, Vol 13.01.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.7. Workmanship, Finish, and Appearance7.1 Finish:7.1.1 SurfacesSurfaces of the instrument shall be uni-formly fin

15、ished 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 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

16、 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 respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly

17、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 at any time by the responsible technical committee and must be reviewed every five years andif not revised, eit

18、her 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 comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend

19、. 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 by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Ind

20、ividual 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).TABLE 1 Suture/Needle/Holder RelationshipSuture NeedleHolderMost

21、 CommonUseRecommendedTeethPerSquare InchCompatibleSuture Size PerUSPACorrespondingWire Size(Diameter)of NeedleDebakey 7 thru 12 in. vascular andvalve2500 02-00.16 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 (2002)2