1.1 本规范规定了植入骨内的金属骨螺钉的材料、光洁度和标记、护理和处理要求，以及可接受的尺寸和公差。本规范中的尺寸和公差仅适用于本规范中描述的金属骨螺钉。 1.2 本规范提供了用于测量植入骨中的金属骨螺钉的扭转机械性能的性能考虑和标准测试方法。除了此处规定的尺寸和公差外，这些试验方法也可适用于其他螺钉。包括以下附件: 1.2.1、 附件A1 -金属骨螺钉扭转性能测定的试验方法。 1.2.2 附件A2 -医用骨螺钉驱动力矩的试验方法。 1.2.3 附件A3 -医用骨螺钉轴向拔出载荷测定的试验方法。 1.2.4 附件A4 -自攻医用骨螺钉自攻性能测定的试验方法。 1.2.5 附件A5 -HA型和HB型金属骨螺钉规范。 1.2.6 附件A6 -HC型和HD型金属骨螺钉规范。 1.2.7 附件A7 -金属骨螺钉驱动连接规范。 1.3 本规范部分基于ISO 5835、ISO 6475和ISO 9268。 1.4 以国际单位制表示的数值应视为标准。本标准中不包括其他计量单位。 1.5 本标准包括多种试验方法。 然而，用户不一定有义务使用所有描述的方法进行测试。相反，用户应该只选择适合特定设备设计的测试方法，并说明理由。这可能仅仅是本文所描述的测试方法的子集。 1.6 本标准可能涉及危险材料、操作和设备的使用。 本标准并非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。 1.7 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。 ====意义和用途====== A1.1条 意义和用途 A1.1.1 该试验方法用于在标准条件下测量接骨螺钉的扭转屈服强度、最大扭矩和断裂角度。在该试验方法中获得的结果并不旨在预测在人或动物骨骼中插入或移除骨螺钉时遇到的扭矩。该测试方法仅用于测量测试产品的均匀性，或比较不同但尺寸相似的产品的机械性能。

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 A2 —Test Method for Driving Torque of Medical Bone Screws. 1.2.3 Annex A3 —Test Method for Determining the Axial Pullout Load 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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods. 1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 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. ====== Significance And Use ====== A1.1 Significance and Use A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.