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Standard Specification for Fixation Pins and Wires 固定销和固定线的标准规范
发布日期: 2024-01-01
1.1 本规范涵盖固定销和电线的功能尺寸。 1.2 认识到这种引脚和导线的许多广泛和不同的用途,包括许多选项。中说明了各种(但不一定全部)选项 图1- 3. . 图1 固定销和固定线 注1: 销和金属丝可以是光滑的柄或螺纹。 注2: 点角和螺旋角(如适用)由制造商规定。 注3: 在方形或三角形柄上,平面相等,角与销直径在同一圆周上。大于3.2 mm的销的柄直径可以减小。 注4: 可选设计,两端尖头或带缝合孔。 图2 固定销——Knowles型 注1: 应由一块材料制成;即不是两个或多个部件的组件。 注2: 螺纹大直径可以与轴直径相同或大于轴直径。 注3: 螺纹长度应是可选的,以适应预期的医疗应用。 注4: 此位置的可选标记。 图3 Hagie型固定销 注1: 螺纹大直径可以与轴直径相同或大于轴直径。 注2: 螺纹长度应是可选的,以适应预期的医疗应用。 1.3 以国际单位制表示的数值应视为标准。本标准不包括其他计量单位。 1.4 本标准并不旨在解决与其使用相关的所有安全问题(如有)。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。
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 Wires Note 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 Type Note 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 Type Note 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.
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归口单位: F04.21
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