ASTM F1325-1991(2016) Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods《不锈钢缝合针夹的标准规格 通用工艺要求和相应的试验方法》.pdf

1、Designation: F1325 91 (Reapproved 2016)Standard 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 oforigin

2、al 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.1. Scope1.1 This specification covers general workmanship aspectsof stainless

3、 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 Methods for Vickers Hardness and Knoop Hard-ness of Metallic MaterialsE140 Hardness Conversion Tables for Metals RelationshipAmon

4、g 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 ForcepsF1089 Test Method for Corrosion of Surgical Inst

5、ruments3. 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 (such as by brazing) to the basemetal.3.1.2 Discussi

6、onThe 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 method, the insert is brazed to thejaw face with a

7、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 terms specified herein, shall be in accordance

8、with Terminology 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 1). Themodified working end may be made o

9、f stellite (trademarked),tungsten carbide, 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.5.1.1 Stainless steel component parts

10、 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 working surface whose Rockwell ha

11、rdness 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 for the modifying material.6. Perfo

12、rmance 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,upon engagement of the second ratchet of the suture needle1This specification is under the jurisdict

13、ion 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 Oct. 1, 2016. Published October 2016. Originallyapproved in 1991. Last previous edition approved in 2008 as F1325 91

14、(2008)1.DOI: 10.1520/F1325-91R16.2For 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 onthe ASTM website.Copyright ASTM International

15、, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1holder, 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 the instrume

16、nt 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 inTerminology F921 or as specified by the purchaser.7.2 Workmanship:7.2.1 Finger rings-inside surfaces of the finger rings shall be

17、well 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. Users of this standar

18、d 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 every five years andif

19、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 technical committee, whic

20、h 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 Conshohocken, PA 19428-2959,Un

21、ited 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). Permission rights to photocopy the standard may

22、 also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 1 Suture/Needle/Holder RelationshipSuture NeedleHolderMost CommonUseRecommendedTeethPerSquare InchCompatibleSuture Size PerUSPACorrespondingWire Size(Diameter)of NeedleDebakey 7 th

23、ru 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.F1325 91 (2016)2