ASTM F1026-1986(2008) Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps.pdf

1、Designation: F 1026 86 (Reapproved 2008)Standard Specification forGeneral Workmanship and Performance Measurements ofHemostatic Forceps1This standard is issued under the fixed designation F 1026; the number immediately following the designation indicates the year oforiginal adoption or, in the case

2、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 Defense.1. Scope1.1 This specif

3、ication covers general workmanship aspectsof hemostatic forceps fabricated from stainless steel andintended for reuse in surgery.2. Referenced Documents2.1 ASTM Standards:2E18 Test Methods for Rockwell Hardness of MetallicMaterialsE92 Test Method for Vickers Hardness of Metallic Mate-rialsE 140 Hard

4、ness 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 Forceps3. Terminol

5、ogy3.1 Definitions applicable to hemostatic forceps shall be inaccordance with Definitions F 921.4. 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 F 899.5. Physical Requirements5.1 He

6、at Treatment and Hardness for Component Parts:5.1.1 The component parts of the instruments shall be heattreated under conditions recommended for the material used.Typical heat treating guidelines and hardness values are shownin Specification F 899.5.1.2 The hardness of all opposing parts of the same

7、instrument shall not vary in hardness by more than 4 units onthe Rockwell Hardness C scale (HRC) or equivalent.5.2 PassivationInstruments and instrument componentsshall be passivated after completion of all fabricating andfinishing operations.6. Performance Requirements6.1 Finger RingsInside surface

8、s shall be well roundedand polished and shall comply with the requirements in 7.1.6.2 Jaw Serrations and TeethJaw serrations and teethshall be of the types specified in Definitions F 921. Theserrations and teeth shall be of uniform depth and height andwell defined to provide effective gripping. The

9、serrations andteeth shall interdigitate. The edges of the serrations shall bechamfered.6.3 Box LockThe hemostatic forceps shall be of box lockconstruction, as defined in Definitions F 921. The pin, or otherfastening component, shall be permanently secured. The jointperformance of the box lock shall

10、be smooth, of equalresistance, and non-binding when opening or closing theforceps to an included angle of 90 6 5 (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

11、gap that existswhen the instrument is viewed from both the front and sideprofile or end view of the instrument (excluding bevel) (seeFig. 1).6.5 RatchetsRatchet and ratchet catch shall securely en-gage at each ratchet position in a smooth and progressivemanner.6.6 Jaw and Ratchet SettingThe jaw tips

12、 shall close andinterdigitate when the first ratchet position is engaged, andthere shall be no visible misalignment of the jaws. The jaws1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F0

13、4.33 on Medical/Surgical Instruments.Current edition approved Feb. 1, 2008. Published March 2008. Originallyapproved in 1986. Last previous edition approved in 2002 as F 1026 86 (2002).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceast

14、m.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 Conshohocken, PA 19428-2959, United States.shall progressively tighten with each succeeding ratchet en-g

15、agement. Each ratchet position shall hold firmly and releaseeasily. The jaws shall be fully closed and the serrationsinterdigitated 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 ofpassin

16、g the test for elasticity 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, shar

17、p edges, cracks, coarsemarks, and manufacturing materials.7.2 TypeThe finish shall be one of the types defined inDefinitions F 921, or as required by the purchaser.8. Test Methods8.1 HardnessHardness shall be determined in accordancewith Test Methods E18or Test Method E92. Conversion ofVickers hardn

18、ess values to Rockwell values shall be inaccordance with Conversion Tables 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

19、 for 24 h at 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 manufacturer

20、s or con-tractors 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 location of markings shall be on a suitable surfaceof the instrument.ASTM Internation

21、al 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 advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their

22、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, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be

23、addressed to ASTM 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,

24、 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. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-95

25、85 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).FIG. 1 Clearance of ForcepsTABLE 1 Test Material Thickness 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)F 1026 86 (2008)2