【国外标准】 Standard Specification for Fixation Pins and Wires

This specification covers the material requirements and functional dimensions for fixation pins and wires. Factors such as bending strength, fatigue strength, break strength (Knowles type only), torsion strength, and ductility are considered important but the values and associated test methods for which have not been established yet.1.1 This specification covers functional dimensions for fixation pins and wires.1.2 In recognition of many broad and varied uses of such pins and wires, many options are included. A variety, but not necessarily all, of the options are illustrated in Figs. 1-3.FIG. 1 Fixation Pins and WiresNOTE 1: Pins and wires may be smooth shank or threaded.NOTE 2: Point angle and helix angle, where applicable, is as specified by the manufacturer.NOTE 3: On square or triangular shanks, flats are equal and corners are on the same circumference as the pin diameter. Shank diameters on pins larger than 3.2 mm may be reduced.NOTE 4: Optional designs, both ends pointed or point with suture hole.FIG. 2 Fixation Pin—Knowles TypeNOTE 1: Shall be made of one piece of material; that is, not an assembly of two or more pieces.NOTE 2: Thread major diameter may be the same or larger than the shaft diameter.NOTE 3: Thread length shall be optional to suit the intended medical application.NOTE 4: Optional marking in this location.FIG. 3 Fixation Pin—Hagie TypeNOTE 1: Thread major diameter may be the same or larger than the shaft diameter.NOTE 2: Thread length shall be optional to suit the intended medical application.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.