ASTM F1325-1991(2008) Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods.pdf

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1、Designation: F 1325 91 (Reapproved 2008)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:2E 18 Test Methods for Rockwell Hardness of MetallicMaterialsE 92 Test Method for Vickers Hardness of Metallic Mate-

4、rialsE 140 Hardness Conversion Tables for Metals RelationshipAmong Brinell Hardness, Vickers Hardness, RockwellHardness, Superficial Hardness, Knoop Hardness, andScleroscope HardnessF 899 Specification for Wrought Stainless Steels for Surgi-cal InstrumentsF 921 Terminology Relating to Hemostatic For

5、cepsF 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 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. For the jawinsert method, the ins

7、ert is brazed to the jaw face with auniform deposit of silver solder which is free of crevices 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 spe

8、cified 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 type 410, 410X, 416, 420A, 420B, 420C, 420F,420F Mod, and 440B per Specification F 899 (se

9、e Note 1). Themodified working end may be made of stellite, tungstencarbide, or other suitable 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

10、.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 modified

11、 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 with modified working ends shallbe subject to corrosion tests as specified in Test Method F 1089except

12、 for the modifying material.6. Performance Requirements6.1 Needle retention testFrom Table 1, 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,1This specification is under the jurisdiction of ASTM Committee

13、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. Originallyapproved in 1991. Last previous edition approved in 2002 as F 1325 91 (2002).2For referenced

14、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 onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Consh

15、ohocken, PA 19428-2959, United States.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-poundtorsion.7. Workmanship, Finish, and Appearance7.1 Finish:7.1.1 SurfacesSurfaces of th

16、e 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 F 921 or as specified by the purchaser.7.2 Workmanship:7.2.1 Finger rings-inside surfaces of the f

17、inger 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 respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. U

18、sers 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 at any time by the responsible technical committee and must be reviewed eve

19、ry 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 comments will receive careful consideration at a meeting of theresponsible techn

20、ical 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 by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohock

21、en, 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).TABLE 1 Suture/Needle/Holder

22、 RelationshipSuture NeedleHolderMost 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 (2008)2