ASTM F1840-2010 Standard Terminology for Surgical Suture Needles《外科缝针标准术语》.pdf

1、Designation: F1840 10Standard 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 in parentheses indi

2、cates 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):attachment area, np

3、ortion 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, nthe shape of the n

4、eedle 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. 3).cutting egde, ncutting edges are made of various goemetricshapes, that is, triangular, diamond, and hexagonal. T

5、hevarious 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 of theneedle body.n

6、eedle 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 of the point. Some

7、 commonpoint configurations include, but are not limited to (see Fig.2): 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 crimp the end of the

8、needle andfirmly hold the suture in place2.2 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 reflective surface(as com

9、pared 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 the yield bend moment

10、occurs.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 Materials and Device

11、s and is the direct responsibility ofSubcommittee F04.33 on Medical/Surgical Instruments.Current edition approved June 1, 2010. Published July 2010. Originally approvedin 1997. Last previous edition approved in 2004 as F1840 - 98a (2004). DOI:10.1520/F1840-10.1Copyright ASTM International, 100 Barr

12、Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.FIG. 1 Schematic of a Surgical NeedleFIG. 2 Typical Point ConfigurationsF1840 102APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 Because there is a clinical need for a variety ofsurgical suture needles for surgical proced

13、ures, 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. However, t

14、heintent 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 this standard

15、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 no

16、t 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, which

17、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,Unit

18、ed 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 ASTM website (www.astm.org/COPYRIGHT/).F1840 103