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【英文标准名称】: Standard Specification and Test Methods for Metallic Medical Bone Screws 【原文标准名称】: 金属医疗骨螺钉的标准规范和试验方法 【标准号】: ASTM F543-2007 【标准状态】: 现行 【国别】: 【发布日期】: 2007 【实施或试行日期】: 【发布单位】: 美国材料与试验协会(US-ASTM)【起草单位】: F04.21【标准类型】: (Specification)【标准水平】: ()【中文主题词】: 骨螺钉;医疗设备;医学科学;螺钉;规范(验收)【英文主题词】: bone screw; dimensions; insertion; performance requirements; pullout; static; test methods; torsion【摘要】: 1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:1.2.1 Annex A1 - Test Method for Determining the Torsional Properties of Metallic Bone Screws.1.2.2 Annex A 2 - Test Method for Driving Torque of Medical Bone Screws.1.2.3 Annex A3 - Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.1.2.4 Annex A4 - Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.1.2.5 Annex A5 - Specifications for Type HA and Type HB Metallic Bone Screws.1.2.6 Annex A6 - Specifications for Type HC and Type HD Metallic Bone Screws.1.2.7 Annex A7 - Specifications for Metallic Bone Screw Drive Connections.1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.1.4 Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values in parentheses are given for information only.This standard may involve the use of hazardous materials, operations, and equipment. 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 and health practices and determine the applicability of regulatory limitations prior to use.1.5 This annex specifies the requirements for a variety of drive connections that can be implemented in metallic medical bone screws. The screw's drive connection supplies the interconnection that is typically used in orthopedic surgery for inserting and removing bone screws.【中国标准分类号】: C35【国际标准分类号】: 11_040_40【页数】: 20P.;A4【正文语种】:
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