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ASTM_F_921_-_10_2011.pdf

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1、Designation:F92110(Reapproved 2011)Standard Terminology Relating toHemostatic Forceps1This standard is issued under the fixed designation F921;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in paren

2、theses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This terminology covers basic terms and considerationsfor the components of hemostatic forceps.Instruments in thisterminology are limited to those fabricat

3、ed from stainless steeland for general surgical procedures.See Fig.1 and Fig.2.2.Referenced Documents2.1 ASTM Standards:2F899 Specification for Wrought Stainless Steels for SurgicalInstruments2.2 ISO Standard:ISO 7151 Instruments for SurgeryHemostatic ForcepsGeneral Requirements33.TerminologyDefinit

4、ions of Hemostatic Forcepsbox lockthe junction where the female member and the malemember are secured,forming the pivoting feature.distal endthe working end,comprised of two jaws,that isfurthest from the surgeon when in use.female memberthe component that accommodates andencloses the male member at

5、the box lock junction.finger ringsthe feature of both the female and the malemembers that forms the gripping surface for the surgeon(commonly classified as the ring-handled feature in ISO7151).hemostatic forcepsan instrument,available in various sizesand configurations,used in surgical procedures fo

6、r thecompression of blood vessels and the grasping of tissue.jawsparts that contain serrations to interrupt the flow ofblood through any vessel.male memberthe component that is inserted through thefemale member and secured to the female member at the boxlock junction.proximal endthat portion of the

7、instrument that is closest tothe surgeon when in use.ratchetsthe portion of both the female and male members atthe proximal end possessing inclined teeth and that form thelocking mechanism.serrations or teeththe gripping or clamping surfaces of thejaws or ratchets.shankthe part of either the female

8、or the male member thatyields configuration,length,and leverage.Definitions of Physical Properties of Hemostatic Forcepschamferthe broken edge of the jaw serrations and theexternal edges of the box lock surfaces.corrosionthe formation of rust.elasticitythe capacity of the instrument to undergo induc

9、edstress without permanent distortion or breakage of anycomponent.finish,nfinal surface visual appearance classified as follows:bright or mirror finish,nhighly reflective surface.satin,matte,or black finish,nreduced reflective surface(as compared to bright or mirror finish)varying from a dullappeara

10、nce to a blackened surface.hardnessa measurement of the resistance to indentation.interdigitationthe interlocking or meshing of the female andmale jaw serrations.jaw alignmentthe positioning of the female and male jawswith respect to interdigitation(related to box lock functionand ratchet performanc

11、e).passivationthe changing of the chemically active surface ofstainless steel to a much less reactive state.stainless steelthe raw material on the instrument that is inaccordance with Specification F899.1This terminology is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials

12、 and Devices and is the direct responsibility of SubcommitteeF04.33 on Medical/Surgical Instruments.Current edition approved June 1,2011.Published July 2011.Originally approvedin 1985.Last previous edition approved in 2010 as F921 10.DOI:10.1520/F0921-10R11.2For referenced ASTM standards,visit the A

13、STM 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.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/

14、www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 FIG.1 Components of a Hemostatic ForcepsF921 10(2011)2 APPENDIX(Nonmandatory Information)X1.RATIONALEX1.1 Because there is a clinical need for a variety ofinstruments for genera

15、l and surgical procedures,they aremanufactured in various configurations and from various typesof stainless steel.For practical purposes and patient safety,these devices supplied by different manufacturers necessitate adefined system of categorization,materials,and performancerequirements.X1.2 This

16、is the first standard of a multiple part standard thatdefines the components of a hemostatic forceps designed forrepeated use,including various terminology that describesperformance considerations.X1.3 Box LockThe box lock construction defined in thisterminology is the most commonly produced junction forhemostatic forceps.However,the intent is not to prohibittechnological innovation or to exclude instruments manufac-tured with other types of pivoting features such as lap joints.X1.4 Disposable i

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