ASTM F1026-1986(2014) Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps《止血钳的一般工艺和性能测量的标准规格》.pdf

1、Designation: F1026 86 (Reapproved 2014)Standard Specification forGeneral Workmanship and Performance Measurements ofHemostatic Forceps1This standard is issued under the fixed designation F1026; the number immediately following the designation indicates the year oforiginal adoption or, in the case of

2、 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 hemostatic forceps fabricated from stai

3、nless steel andintended for reuse in surgery.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Test Methods for Rockwell Hardness of Metallic Ma-terialsE92 Test Method for Vickers Hardness of Metallic Materials(Withdrawn 2010)3E140 Hardness Conversion Tables for Metals RelationshipAmong Brinell Hardnes

4、s, Vickers Hardness, RockwellHardness, Superficial Hardness, Knoop Hardness, Sclero-scope Hardness, and Leeb HardnessF899 Specification for Wrought Stainless Steels for SurgicalInstrumentsF921 Terminology Relating to Hemostatic Forceps3. Terminology3.1 Definitions applicable to hemostatic forceps sh

5、all be inaccordance with Definitions F921.4. Material4.1 All of the component parts of the instruments shall bemade of martensitic stainless steel of Type 410, 410X, 416,416MOD, 420A, or 420B of Specification F899.5. Physical Requirements5.1 Heat Treatment and Hardness for Component Parts:5.1.1 The

6、component parts of the instruments shall be heattreated under conditions recommended for the material used.Typical heat treating guidelines and hardness values are givenin Specification F899.5.1.2 The hardness of all opposing parts of the sameinstrument shall not vary in hardness by more than 4 unit

7、s onthe Rockwell Hardness C scale (HRC) or equivalent. (See TestMethods E18.)5.2 PassivationInstruments and instrument componentsshall be passivated after completion of all fabricating andfinishing operations.6. Performance Requirements6.1 Finger RingsInside surfaces shall be well rounded andpolishe

8、d and shall comply with the requirements in 7.1.6.2 Jaw Serrations and TeethThe serrations and teethshall be of uniform depth and height and well defined toprovide effective gripping. The serrations and teeth shallinterdigitate. The edges of the serrations shall be chamfered.6.3 Box LockThe hemostat

9、ic forceps shall be of box lockconstruction, as defined in Definitions F921. The pin, or otherfastening component, shall be permanently secured. The jointperformance of the box lock shall be smooth, of equalresistance, and non-binding when opening or closing theforceps to an included angle of 90 6 5

10、 (the lock may belubricated).6.4 ClearanceThe maximum clearance between the maleand female members of the forceps in the lock area shall be 0.4mm (0.015 in.). The clearance is the visible gap that existswhen the instrument is viewed from both the front and sideprofile or end view of the instrument (

11、excluding bevel) (seeFig. 1).6.5 RatchetsRatchets shall securely engage at each ratchetposition in a smooth and progressive manner.6.6 Jaw and Ratchet SettingThe jaw tips shall close andinterdigitate when the first ratchet position is engaged, andthere shall be no visible misalignment of the jaws. T

12、he jawsshall progressively tighten with each succeeding ratchet en-gagement. Each ratchet position shall hold firmly and releaseeasily. The jaws shall be fully closed and the serrations1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices an

13、d is the direct responsibility ofSubcommittee F04.33 on Medical/Surgical Instruments.Current edition approved Oct. 1, 2014. Published November 2014. Originallyapproved in 1986. Last previous edition approved in 2008 as F1026 86 (2008)1.DOI: 10.1520/F1026-86R14.2For referenced ASTM standards, visit t

14、he 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.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM I

15、nternational, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1interdigitated when the last ratchet is engaged. The jaws shallnot open as the result of engaging any ratchet position.6.7 ElasticityThe instrument by design shall be capable ofpassing the test for elas

16、ticity as specified in 8.2. After comple-tion of the test, no visible distortion, cracks, or other visibledamage to the instrument shall be evident.7. Workmanship, Finish, and Appearance7.1 SurfacesThe surfaces of the instrument shall be uni-formly finished and free of burrs, sharp edges, cracks, co

17、arsemarks, and manufacturing materials.7.2 TypeThe finish shall be one of the types defined inDefinitions F921, or as required by the purchaser.8. Test Methods8.1 HardnessHardness shall be determined in accordancewith Test Methods E18 or Test Method E92. Conversion ofVickers hardness values to Rockw

18、ell values shall be inaccordance with the Conversion Tables in E140.8.2 ElasticityThe instrument shall have a segment ofbasswood, leather strap, or stainless steel wire test materialplaced between the jaws at the tip. The instrument shall beengaged in the last (tightest) ratchet position for 24 h at

19、 roomtemperature. The thickness of the test material shall be as listedin Table 1.8.3 Corrosion ResistanceInstruments or instrument com-ponents shall be subject to the corrosion tests.9. Marking and Labeling9.1 All markings shall be legible.9.2 The instrument shall bear: the manufacturers or con-tra

20、ctors name or registered trademark; the country of origin,when the instrument is not manufactured in the United States;and other markings as required by the purchaser, manufacturer,or contractor.9.3 The markings shall be located on a suitable surface ofthe instrument.ASTM International takes no posi

21、tion respecting 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 responsibili

22、ty.This standard 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 AST

23、M International 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

24、shown below.This 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-

25、832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 1 Clearance of ForcepsTABLE 1 Test Material T

26、hickness and Instrument LengthThickness or Diameter ofTest Material, mm (in.)Nominal Overall Length ofInstrument, mm (in.)1.982.00 (0.07810.0787) Up to and including 127 (5)3.003.18 (0.11810.1250) Over 127 to 150 (5 to 5.906)3.974.00 (0.15630.1575) Over 150 to 177.8 (5.906 to 7.000)4.765.00 (0.18750.1969) Over 177.8 (7.000)F1026 86 (2014)2