ASTM F1840-2010(2016) Standard Terminology for Surgical Suture Needles《外科缝合针的标准术语》.pdf

1、Designation: F1840 10 (Reapproved 2016)Standard Terminology forSurgical Suture Needles1This standard is issued under the fixed designation F1840; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number i

2、n parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This terminology covers general definitions for surgicalneedles.2. Terminology2.1 Definitions of Terms Specific to the Instrument (See Fig.1):a

3、ttachment area, nportion of the needle where the attach-ment of the suture takes place. For example, eyed, drilled,and channel.body, ncentral portion of the needle intended to be graspedby the needle holder.chord length, nthe straight line distance between the twoends of a curved needle.curvature, n

4、the shape of the needle viewed in profile. Somecommon shapes include, but are not limited to: straight,12curve or “ski,”18 circle,14 circle,38 circle,12 circle,58circle, and compound curvature (see Fig. 2).cutting edge, ncutting edges are made of various geometricshapes, that is, triangular, diamond

5、, and hexagonal. Thevarious edges may be sharpened by the manufacturer de-pending on the user performance.needle length, nthe distance measured along the needlecurvature from end to end.needle radius, nthe radius of the uniformly curved portionor portions of the needle measured from the centerline o

6、f theneedle body.needle wire diameter, nthe gage or thickness of the needlewire, measured at a location between the needle body andthe attachment area, where either no or minimal work hastaken place.point, nportion of the needle intended to initiate tissuepenetration.point configuration, nthe shape

7、of the point. Some commonpoint configurations include, but are not limited to (see Fig.3): taper, trocar, blunt, spatulated, conventional cutting edge,reverse cutting edge, cutting taper, and side cutting needle.swage, nthe term used to describe any attachment methodthat uses mechanical force to cri

8、mp the end of the needle andfirmly hold the suture in place.2.2 Definitions of Terms Specific to Mechanical Propertiesof a Surgical Needle:finish, nfinal surface visual appearance classified as follows:bright or mirror finish, nhighly reflective surface.satin, matte, or black finish, nreduced reflec

9、tive surface (ascompared to bright or mirror finish) varying from a dullappearance to a blackened surface.maximum bend momentthe greatest moment applied to aneedle during a bend test.needle ducilitya measure of the amount of plastic bending aneedle can withstand.yield bend anglethe angle at which th

10、e yield bend momentoccurs.yield bend momentthe amount of moment required toinitiate plastic deformation during a bend test.3. Keywords3.1 needle; stainless steel- surgical applications; surgical;suture needle1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical M

11、aterials 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 1997. Last previous edition approved in 2010 as F1840 101. DOI:10.1520/F1840-10R16.Copyright ASTM Internati

12、onal, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1FIG. 1 Schematic of a Surgical NeedleFIG. 2 Typical CurvaturesF1840 10 (2016)2APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 Because there is a clinical need for a variety ofsurgical suture needles for sur

13、gical procedures, they are manu-factured in various configurations and from various materials.For practical purposes these devices supplied by differentmanufacturers necessitate a defined system of terms.X1.2 The terms defined in this terminology are the mostcommonly used for surgical suture needles

14、. However, theintent is not to prohibit technological innovation or to excludesurgical suture needles manufactured with other types offeatures.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of th

15、is 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 every five ye

16、ars 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 technical commi

17、ttee, 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 Conshohocken, PA 194

18、28-2959,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). 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:/ 3 Typical Point ConfigurationsF1840 10 (2016)3