Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System ${}^1$${}^1$^(1){ }^{1}
脊柱骨骼系统手术固定所用组件的标准规格和测试方法 ${}^1$${}^1$^(1){ }^{1}

1.1 These specifications and test methods are intended to provide a comprehensive reference for the components of systems used in the surgical fixation of the spinal skeletal system. The document catalogs standard specifications that specify material, labeling, and handling requirements. The specifications and test methods also establish common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components. Additionally, the specifications and test methods establish performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components.
1.1 本规范和测试方法旨在为脊柱骨骼系统手术固定中使用的系统组件提供全面的参考。本文件收录了规定材料、标签和处理要求的标准规范。规范和测试方法还建立了通用术语，可用于描述脊柱组件的尺寸和其他物理特征，以及与脊柱组件性能相关的性能定义。此外，这些规范和测试方法还制定了性能要求和标准测试方法，用于统一测量脊柱组件与性能相关的机械特性。
1.2 These specifications and test methods are part of a series of standards addressing systems used in the surgical fixation of the spinal skeletal system. These specifications and test methods concentrate on the individual components, which are found in many spinal fixation systems. If the user is interested in evaluating the next level in the spinal fixation system chain, the interconnections between individual components and subassemblies (two or more components), the user should consult Guide F1798. At the highest level in this chain is Test Methods F1717, which is used to evaluate an entire construct assembled from many components and involves numerous interconnections and several subassemblies.
1.2 本规范和测试方法是针对脊柱骨骼系统手术固定系统的系列标准的一部分。这些规范和测试方法主要针对许多脊柱固定系统中的单个组件。如果用户有兴趣评估脊柱固定系统链中的下一级，即单个组件和子组件（两个或多个组件）之间的互连，则应参考指南 F1798。该链的最高级别是测试方法 F1717，用于评估由多个组件组装而成的整个结构，涉及众多互连和多个子组件。
1.3 It is not the intention of these specifications and test methods to define levels of performance or case-specific clinical performance for spinal components addressed by this document. Insufficient knowledge to predict the consequences of using any of these components in individual patients for specific activities of daily living is available. Furthermore, it is not the intention of this document to describe or specify specific designs for the individual components of systems used in the surgical internal fixation of the spinal skeletal system.
1.3 本规范和测试方法无意为本文件所涉及的脊柱部件定义性能水平或特定病例的临床表现。目前还没有足够的知识来预测这些组件在个别患者身上用于特定日常生活活动的后果。此外，本文件无意描述或规定用于脊柱骨骼系统手术内固定的系统单个组件的具体设计。

1.4 These specifications and test methods may not be appropriate for all types of spinal surgical fixation systems. The user is cautioned to consider the appropriateness of this document in view of the particular implant system and its potential application.
1.4 这些规范和测试方法可能并不适用于所有类型的脊柱外科固定系统。用户应根据具体的植入系统及其潜在应用来考虑本文件的适用性。
1.5 This document includes the following specifications and test methods that are used in determining the spinal component’s mechanical performance characteristics:
1.5 本文件包括以下用于确定脊柱组件机械性能特征的规格和测试方法：
1.5.1 Specification for Metallic Spinal Screws-Annex A1.
1.5.1 金属脊柱螺钉规范-附件 A1。
1.5.2 Specification for Metallic Spinal Plates-Annex A2.
1.5.2 金属脊柱板规范--附件 A2。
1.5.3 Specification for Metallic Spinal Rods-Annex A3.
1.5.3 金属脊髓棒规范-附件 A3。
1.5.4 Test Method for Measuring the Static and Fatigue Bending Strength of Metallic Spinal Screws-Annex A4.
1.5.4 测量金属脊柱螺钉静态和疲劳弯曲强度的试验方法--附件 A4。
1.6 Unless otherwise indicated, the values stated in SI units shall be regarded as the standard.
1.6 除非另有说明，以国际单位制单位表示的数值应视为标准值。
1.7 This standard may involve 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 本标准可能涉及危险材料、操作和设备。本标准无意解决与使用本标准有关的所有安全问题（如果有的话）。本标准的使用者有责任在使用前制定适当的安全、健康和环保措施，并确定法规限制的适用性。
1.8 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.
1.8 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》中确定的国际公认的标准化原则制定的。

E4 Practices for Force Verification of Testing Machines
E4 试验机测力验证方法
E6 Terminology Relating to Methods of Mechanical Testing E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
E6 与机械测试方法有关的术语 E122 按规定精度计算样本量以估计批量或过程特性平均值的方法

E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
E467 轴向疲劳试验系统中恒定振幅动态力的验证方法
E1823 Terminology Relating to Fatigue and Fracture Testing E1942 Guide for Evaluating Data Acquisition Systems Used in Cyclic Fatigue and Fracture Mechanics Testing
E1823 疲劳和断裂测试相关术语 E1942 循环疲劳和断裂力学测试数据采集系统评估指南
F382 Specification and Test Method for Metallic Bone Plates
F382 金属骨板的规格和测试方法
F543 Specification and Test Methods for Metallic Medical Bone Screws
F543 金属医用骨螺钉的规格和测试方法
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
F565 骨科植入物和器械的护理和处理规范
F983 Practice for Permanent Marking of Orthopaedic Implant Components
F983 骨科植入组件永久标记规范
F1582 Terminology Relating to Spinal Implants
F1582 与脊柱植入物有关的术语
F1717 Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
F1717 脊骨切除术模型中脊柱植入结构的测试方法
F1798 Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
F1798 用于评估脊柱关节固定植入物中使用的互连机制和子组件的静态和疲劳特性的测试方法
F1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
F1839 硬质聚氨酯泡沫用作测试矫形设备和器械的标准材料的规范
F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment F2943 Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
F2503 在磁共振环境中对医疗器械和其他物品进行安全标记的做法 F2943 肌肉骨骼植入物最终用户标签信息表述指南
2.2 ASTM Standards: Materials ${}^2$${}^2$^(2){ }^{2}
2.2 ASTM 标准：材料 ${}^2$${}^2$^(2){ }^{2}

D4020 Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials
D4020 超高分子量聚乙烯成型和挤出材料规范
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F67 外科植入应用非合金钛规范（UNS R50250、UNS R50400、UNS R50550、UNS R50700）
F136 Specification for Wrought Titanium-6Aluminum4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
F136 外科植入物用锻造钛-6 铝-4 钒 ELI（超低间隙）合金（UNS R56401）规范
F138 Specification for Wrought 18Chromium-14Nickel2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
F138 外科植入物用锻造 18 铬-14 镍-2.5 钼不锈钢棒材和线材规格（UNS S31673）
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F648 外科植入物用超高分子量聚乙烯粉末及制成品规范
F1295 Specification for Wrought Titanium-6Aluminum7Niobium Alloy for Surgical Implant Applications (UNS R56700)
F1295 外科植入应用锻造钛-6 铝-7 铌合金（UNS R56700）规范
F1314 Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
F1314 用于外科植入物的锻造氮强化 22 铬-13 镍-5 锰-2.5 钼不锈钢合金棒材和线材（UNS S20910）规范
F1472 Specification for Wrought Titanium-6Aluminum4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
F1472 外科植入物用锻造钛-6 铝-4 钒合金（UNS R56400）规范
2.3 ISO Standards: 2.3 ISO 标准：

ISO 14630 Non-active Surgical Implants-General Requirements ${}^3$${}^3$^(3)^{3}
ISO 14630 非活动外科植入物--一般要求 ${}^3$${}^3$^(3)^{3}

3.1 Unless otherwise defined in these specifications and test methods, the terminology used in this document that is related to spinal implants will be in accordance with the definitions of Specification F382, Specification F543, and Terminology F1582.
3.1 除非本规范和测试方法另有规定，本文件中使用的与脊柱植入物有关的术语应符合规范 F382、规范 F543 和术语 F1582 的定义。
3.2 Unless otherwise defined in these specifications and test methods, the terminology related to mechanical testing that is used in this document will be in accordance with the definitions of Terminology E6, Terminology E1823, Specification F382, Terminology F1582, Test Methods F1717, and Guide F1798.
3.2 除非本规范和测试方法另有规定，本文件中使用的与机械测试有关的术语应符合术语 E6、术语 E1823、规范 F382、术语 F1582、测试方法 F1717 和指南 F1798 的定义。

3.3.1 expansion head screw, $n$$n$nn-threaded anchor that is designed so that the head can be elastically deformed, through mechanical means, to establish an interconnection with another spinal construct element.
3.3.1 膨胀头螺钉， $n$$n$nn 螺纹锚栓，其设计可使头部通过机械方式发生弹性变形，从而与另一个脊柱构造部件建立相互连接。
3.3.2 locking screw, $n$$n$nn-threaded anchor that is rigidly connected to the longitudinal element of the spinal construct.
3.3.2 锁定螺钉， $n$$n$nn 与脊柱结构纵向部件刚性连接的螺纹锚。
3.3.3 self-locking screw, $n$$n$nn-threaded anchor design that undergoes a deformation process at the end of the insertion process which results in the screw’s locking to the mating spinal construct element.
3.3.3 自锁螺钉， $n$$n$nn 螺纹锚栓设计，在插入过程结束时经历变形过程，从而使螺钉锁定到配合的脊柱构造元件上。
3.3.4 shaft screw, $n$$n$nn-threaded anchor having an unthreaded shank equal to its thread diameter.
3.3.4 轴螺丝， $n$$n$nn 有螺纹的锚栓，其无螺纹柄与其螺纹直径相等。
3.4 Terminology—Geometric:
3.4 术语--几何：
3.4.1 rod diameter ( mm ), $n$$n$nn-length in mm of a chord passing through the center of the rod’s cross-section.
3.4.1 杆件直径（毫米）， $n$$n$nn 通过杆件横截面中心的弦长，以毫米为单位。
3.4.2 rod length ( mm ), $n$$n$nn-overall dimension measured in mm between the ends of a given rod.
3.4.2 杆件长度（毫米）， $n$$n$nn 特定杆件两端之间的总尺寸，以毫米为单位。

3.5.1 $0.2\mathrm{\%}$$0.2\mathrm{\%}$0.2%0.2 \% offset displacement ( mm ), $n$$n$nn-permanent displacement equal to 0.002 times the test gage section length for the specific test, in mm . The test gage section length is equal to the bending moment arm for spinal screw tests. The test gage section length is equal to the center span distance for spinal plate and rod tests where the loading rollers are directly contacting the test specimen (Fig. A2.1 and Fig. A3.1). The test gage section length is equal to the unsupported distance between the ends of the extension segments for spinal plate and rod tests where extension segments are used to load the test sample (Fig. A2.2). (distance $OB$$OB$OBO B in Fig. A4.1).
3.5.1 $0.2\mathrm{\%}$$0.2\mathrm{\%}$0.2%0.2 \% 偏移位移（毫米）， $n$$n$nn 永久位移等于 0.002 乘以特定试验的试验量规截面长度，以毫米为单位。在脊柱螺钉测试中，测试规截面长度等于弯矩臂。对于加载辊直接接触试样的椎板和椎棒试验，测试规截面长度等于中心跨距（图 A2.1 和图 A3.1）。在使用延伸段加载测试样本的脊板和杆测试中，测试量规截面长度等于延伸段两端之间的无支撑距离（图 A2.2）。(图 A4.1 中的距离 $OB$$OB$OBO B ）。
3.5.2 axial pull-out load $(N)$$(N)$(N)(N), $n$$n$nn-tensile force in N required to fail or remove a screw from a material into which the screw has been inserted when tested in accordance with Specification and Test Methods F543, Annex A3.
3.5.2 轴向拉出载荷 $(N)$$(N)$(N)(N) ， $n$$n$nn --按照规格和试验方法 F543 附件 A3 进行试验时，使螺钉失效或从已插入螺钉的材料中取出螺钉所需的拉力，单位 N。
3.5.3 bending fatigue runout moment $(N\cdot m)$$(N\cdot m)$(N*m)(N \cdot m), $n$$n$nn-value in $\mathrm{N}-\mathrm{m}$$\mathrm{N}-\mathrm{m}$N-m\mathrm{N}-\mathrm{m} of the maximum moment that can be applied to a spinal component where all of the tested samples have experienced 2500000 loading cycles without a failure at a specific $R$$R$RR-ratio.
3.5.3 弯曲疲劳跳动力矩 $(N\cdot m)$$(N\cdot m)$(N*m)(N \cdot m) 、 $n$$n$nn -- $\mathrm{N}-\mathrm{m}$$\mathrm{N}-\mathrm{m}$N-m\mathrm{N}-\mathrm{m} 中的值，在特定的 $R$$R$RR 比率下，所有测试样品经历 2500000 次加载循环而未出现故障时，可施加于脊柱部件的最大力矩。
3.5.4 bending moment arm, $L(\mathrm{mm})$$L(\mathrm{mm})$L(mm)L(\mathrm{~mm}), $n$$n$nn-distance in mm between the point where the test sample is gripped (typically the axis of the longitudinal element) and the line-of-action for the applied force prior to any deformation of of the assembly. (See dimension $L$$L$LL of Fig. A4.2).
3.5.4 弯曲力臂， $L(\mathrm{mm})$$L(\mathrm{mm})$L(mm)L(\mathrm{~mm}) ， $n$$n$nn -测试样品的夹持点（通常是纵向元件的轴线）与组件变形之前的外力作用线之间的距离，以毫米为单位。(见图 A4.2 中的尺寸 $L$$L$LL ）。
3.5.5 bending stiffness, $S(N/\mathrm{mm})$$S(N/\mathrm{mm})$S(N//mm)S(N / \mathrm{mm}), $n$$n$nn-slope in $\mathrm{N}/\mathrm{mm}$$\mathrm{N}/\mathrm{mm}$N//mm\mathrm{N} / \mathrm{mm} of the initial linear elastic portion of the load versus total displacement curve (slope of line $Om$$Om$OmO m in Fig. A4.1).
3.5.5 弯曲刚度， $S(N/\mathrm{mm})$$S(N/\mathrm{mm})$S(N//mm)S(N / \mathrm{mm}) ， $n$$n$nn -荷载与总位移曲线（图 A4.1 中 $Om$$Om$OmO m 线的斜率）中初始线性弹性部分的 $\mathrm{N}/\mathrm{mm}$$\mathrm{N}/\mathrm{mm}$N//mm\mathrm{N} / \mathrm{mm} 斜率。
3.5.6 bending ultimate moment ( $N\cdot m$$N\cdot m$N*mN \cdot m ), $n$$n$nn-maximum bending moment in $\mathrm{N}-\mathrm{m}$$\mathrm{N}-\mathrm{m}$N-m\mathrm{N}-\mathrm{m} that can be applied to a test sample. This would correspond to the bending moment at Point $E$$E$EE in Fig. A4.1.
3.5.6 弯曲极限力矩（ $N\cdot m$$N\cdot m$N*mN \cdot m ）， $n$$n$nn -可作用于测试样本的 $\mathrm{N}-\mathrm{m}$$\mathrm{N}-\mathrm{m}$N-m\mathrm{N}-\mathrm{m} 中的最大弯曲力矩。这相当于图 A4.1 中 $E$$E$EE 点处的弯矩。
3.5.7 bending yield moment ( $N\cdot m$$N\cdot m$N*mN \cdot m ), $n-$$n-$n-n- bending moment in $\mathrm{N}-\mathrm{m}$$\mathrm{N}-\mathrm{m}$N-m\mathrm{N}-\mathrm{m} necessary to produce a $0.2\mathrm{\%}$$0.2\mathrm{\%}$0.2%0.2 \% offset displacement in the spinal component. If the specimen fractures before the test reaches the $0.2\mathrm{\%}$$0.2\mathrm{\%}$0.2%0.2 \% offset displacement point, the bending yield moment shall be defined as the bending moment at fracture (point $D$$D$DD in Fig. A4.1).
3.5.7 弯曲屈服力矩（ $N\cdot m$$N\cdot m$N*mN \cdot m ）， $n-$$n-$n-n- 在 $\mathrm{N}-\mathrm{m}$$\mathrm{N}-\mathrm{m}$N-m\mathrm{N}-\mathrm{m} 中产生脊柱部件 $0.2\mathrm{\%}$$0.2\mathrm{\%}$0.2%0.2 \% 偏移位移所需的弯曲力矩。如果试样在试验达到 $0.2\mathrm{\%}$$0.2\mathrm{\%}$0.2%0.2 \% 偏移位移点之前断裂，则弯曲屈服力矩应定义为断裂时的弯曲力矩（图 A4.1 中的 $D$$D$DD 点）。
3.5.8 exposed length ( mm ), $n$$n$nn-linear distance measured in mm between the surface of the test block that the screw is embedded in during the test and the location where the screw is anchored (typically the axis of the longitudinal element) in the test fixture (see Fig. A4.2).
3.5.8 外露长度（毫米）， $n$$n$nn 试验中螺钉嵌入的试块表面与试验夹具中螺钉锚定位置（通常是纵向元件的轴线）之间的线性距离，单位为毫米（见图 A4.2）。
3.5.9 gross failure, $n$$n$nn-permanent displacement resulting from fracture or plastic deformation in excess of the yield displacement that renders the spinal component ineffective in fulfilling its intended function.
3.5.9 严重失效， $n$$n$nn -由于断裂或塑性变形产生的永久位移超过屈服位移，使脊柱部件不能有效地实现其预期功能。
3.5.10 insertion depth ( mm ), $n$$n$nn-linear advancement in mm of the screw into the test block measured relative to its seated position at the test block’s surface prior to testing.
3.5.10 插入深度(毫米)， $n$$n$nn 相对于试验前在试验块表面的就位位置测量的螺钉插入试验块的线性推进量，以毫米为单位。
3.5.11 median bending fatigue moment at $N$$N$NN cycles $(N\cdot m)$$(N\cdot m)$(N*m)(N \cdot m), $n$$n$nn-value in $\mathrm{N}-\mathrm{m}$$\mathrm{N}-\mathrm{m}$N-m\mathrm{N}-\mathrm{m} of the maximum moment that can be applied to a spinal component for which $50\mathrm{\%}$$50\mathrm{\%}$50%50 \% of the test specimens of a given sample can be expected to survive $N$$N$NN loading cycles at a specific $R$$R$RR-ratio.
3.5.11 $N$$N$NN 循环时的弯曲疲劳力矩中值 $(N\cdot m)$$(N\cdot m)$(N*m)(N \cdot m) 、 $n$$n$nn --在 $\mathrm{N}-\mathrm{m}$$\mathrm{N}-\mathrm{m}$N-m\mathrm{N}-\mathrm{m} 中的值，该值是在特定 $R$$R$RR 比率下，对脊柱部件施加的最大力矩，其中 $50\mathrm{\%}$$50\mathrm{\%}$50%50 \% 给定样品的测试试样可望在 $N$$N$NN 加载循环中存活。
3.5.12 permanent displacement ( mm ), $n$$n$nn-total displacement in mm remaining after the applied load has been removed from the test specimen.
3.5.12 永久位移（毫米）， $n$$n$nn 从试验试样上卸除外加载荷后剩余的总位移，以毫米为单位。
3.5.13 torsion yield moment ( $N\cdot m$$N\cdot m$N*mN \cdot m ), $n-$$n-$n-n- applied torque in $\mathrm{N}-\mathrm{m}$$\mathrm{N}-\mathrm{m}$N-m\mathrm{N}-\mathrm{m} at which the screw reaches its proportional limit when tested in accordance with Specification and Test Methods F543, Annex A1. The value is determined by using an offset method with a $2^{\circ }$$2^{\circ }$2^(@)2^{\circ} angular offset.
3.5.13 扭转屈服力矩（ $N\cdot m$$N\cdot m$N*mN \cdot m ）， $n-$$n-$n-n- 在 $\mathrm{N}-\mathrm{m}$$\mathrm{N}-\mathrm{m}$N-m\mathrm{N}-\mathrm{m} 中的应用扭矩，当按照规格和试验方法 F543 附件 A1 进行试验时，螺钉达到其比例极限。该值通过使用 $2^{\circ }$$2^{\circ }$2^(@)2^{\circ} 角度偏移的偏移方法确定。
3.5.14 total displacement ( mm ), $n$$n$nn-distance in mm , in the direction of the applied load, which the load application point has moved relative to the zero load intercept of the initial linear segment of the load versus displacement curve (point 0 in Fig. A4.1).
3.5.14 总位移（毫米）， $n$$n$nn 在施加荷载的方向上，施加荷载点相对于荷载与位移曲线的初始线性段（图 A4.1 中的 0 点）的零荷载截距的移动距离（毫米）。
3.5.15 yield displacement ( mm ), $n$$n$nn-total displacement in mm associated with the bending yield strength (distance $OA$$OA$OAO A in Fig. A4.1).
3.5.15 屈服位移（毫米）， $n$$n$nn -与弯曲屈服强度相关的总位移（毫米）（图 A4.1 中的距离 $OA$$OA$OAO A ）。

4.1 Spinal implant constructs are typically a compilation of several components. Screws, plates, and rods are integral components of many spinal implant constructs. These components are designed to transfer load between the bone and the longitudinal or transverse element, or both. These specifications and test methods identify specifications for such components and define standard equivalent test methods that can be used when evaluating different related component designs.
4.1 脊柱植入物通常由多个组件组成。螺钉、钢板和钢棒是许多脊柱植入物结构的组成部分。这些部件的设计目的是在骨骼和纵向或横向部件之间或两者之间传递载荷。这些规格和测试方法确定了此类组件的规格，并定义了标准等效测试方法，可用于评估不同的相关组件设计。
4.2 Since the loading of spinal components in-vivo may differ from the loading configurations addressed in these specifications and test methods, the results obtained from this document may not predict in-vivo performance of either the components or the construct as a whole. Such tests can, however, be used to compare different component designs in terms of relevant mechanical performance characteristics.
4.2 由于脊柱组件的活体加载可能不同于本规范和测试方法中涉及的加载配置，因此从本文件中获得的结果可能无法预测组件或整个结构的活体性能。不过，此类测试可用来比较不同部件设计的相关机械性能特征。
4.3 The performance-related mechanical characteristics determined by these specifications and test methods will supply the user with information that may be used to predict the mechanical performance of different design variations of similar (function and indication) spinal construct components.
4.3 本规范和试验方法确定的与性能有关的机械特性将为用户提供信息，可用于预测类似 （功能和指示）脊柱结构部件的不同设计变体的机械性能。

5.1 The following spinal components shall conform to the requirements of the listed standard specification:
5.1 下列脊柱部件应符合所列标准规范的要求：
5.1.1 Screws-Standard Specification for Metallic Spinal Screws (see Annex A1).
5.1.1 螺钉-金属脊柱螺钉标准规格（见附件 A1）。
5.1.2 Plates-Standard Specification for Metallic Spinal Plates (see Annex A2).
5.1.2 钢板-金属脊柱钢板标准规格（见附件 A2）。
5.1.3 Rods-Standard Specification for Metallic Spinal Rods (see Annex A3).
5.1.3 脊骨棒-金属脊骨棒标准规格（见附件 A3）。

6.1 Mark spinal components using the methods specified in Practice F983.
6.1 使用规范 F983 中规定的方法标记脊柱组件。
6.2 Markings on spinal components shall identify the manufacturer or distributor. When size permits, the following information should be legibly marked on the spinal component (items listed in order of preference):
6.2 脊骨组件上的标记应标明制造商或经销商。在尺寸允许的情况下，脊柱组件上应清晰标注以下信息（按优先顺序排列）：
6.2.1 Manufacturer’s name or logo,
6.2.1 制造商名称或徽标、
6.2.2 Material and, when applicable, the ASTM designation, 6.2.3 Catalog number,
6.2.2 材料及（如适用）ASTM 名称， 6.2.3 目录号、
6.2.4 Manufacturing lot number, and
6.2.4 制造批号，以及
6.2.5 If the component is manufactured according to an ASTM specification, the ASTM designation.
6.2.5 如果部件是按照 ASTM 规范制造的，则应注明 ASTM 名称。
6.3 Packaging shall be adequate to protect the spinal component during shipment.
6.3 包装应足以在运输过程中保护脊柱组件。
6.4 Package labeling for spinal components shall include the following information:
6.4 脊骨组件的包装标签必须包括以下信息
6.4.1 Manufacturer and product name,
6.4.1 制造商和产品名称、
6.4.2 Catalog number, 6.4.2 目录编号、
6.4.3 Lot or serial number,
6.4.3 批量或序列号、
6.4.4 Material and, when applicable, the ASTM designation for the material, and
6.4.4 材料和（如适用）材料的 ASTM 名称，以及
6.4.5 The sterility condition of the packaged spinal component.
6.4.5 包装脊柱部件的无菌条件。
6.5 Package labeling may elect to follow guidance in Guide F2943 for package label presentation.
6.5 包装标签可选择遵循指南 F2943 中关于包装标签表述的指导。
6.6 Product labeling may include marking for safety in the Magnetic Resonance Environment in accordance with Practice F2503.
6.6 产品标签可包括符合 F2503 规范的磁共振环境安全标记。
6.7 Spinal components shall be cared for and handled according to the requirements specified in Practice F565.
6.7 脊柱部件应按照实践 F565 中规定的要求进行护理和处理。

7.1 The manufacturer is responsible for ensuring that materials used to manufacture spinal components are suitable for implanting into the body. Material suitability can be verified with the methods described in ISO 14630.
7.1 制造商有责任确保用于制造脊柱部件的材料适合植入人体。材料适用性可通过 ISO 14630 中描述的方法进行验证。
7.2 The manufacturer should also consider the materials of other spinal components within the spinal implant construct when selecting a material. Avoid the mixing of materials within a spinal implant construct in order to prevent the development of undesirable corrosion conditions.
7.2 制造商在选择材料时还应考虑脊柱植入物结构中其他脊柱部件的材料。避免脊柱植入物结构内的材料混合，以防止出现不良的腐蚀情况。
7.3 All spinal components that are made of materials that have an ASTM standard designation shall meet those requirements given in the ASTM standards. The following is a list of some materials that have been used for spinal components:
7.3 所有由 ASTM 标准指定的材料制成的脊柱组件均应符合 ASTM 标准中的要求。以下是一些已用于脊柱组件的材料清单：
7.3.1 Unalloyed Titanium (see Specification F67).
7.3.1 非合金钛（见规格 F67）。
7.3.2 Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (see Specification F136).
7.3.2 锻钛-6铝-4钒 ELI（特低间隙）合金（见规格 F136）。
7.3.3 Stainless Steel Bar and Wire (see Specification F138).
7.3.3 不锈钢棒材和线材（见规格 F138）。
7.3.4 Wrought Titanium-6Aluminum-7Niobium Alloy (see Specification F1295).
7.3.4 锻制钛-6铝-7铌合金（见规格 F1295）。
7.3.5 Wrought Nitrogen Strengthened 22Chromium-12.5Nickel-5Manganese-2.5Molybdenum Stainless Steel Bar and Wire (see Specification F1314).
7.3.5 锻氮强化 22 铬-12.5 镍-5 锰-2.5 钼不锈钢棒材和线材（见规格 F1314）。
7.3.6 Wrought Titanium Ti-6Al-4V Alloy (see Specification F1472).
7.3.6 锻钛 Ti-6Al-4V 合金（见规格 F1472）。

8.1 bend testing-plate; bend testing-rod; bend testing-screw; bend testing-surgical implants; fatigue test-plate; fatigue test-rod; fatigue test-screw; fatigue test-surgical implants; orthopedic medical device-plate; orthopedic medical device-rod; orthopedic medical device-screw; orthopedic spinal devices; performance; spinal arthrodesis; surgical devices; terminology; test methods-surgical implants
8.1 弯曲测试-板；弯曲测试-杆；弯曲测试-螺钉；弯曲测试-外科植入物；疲劳测试-板；疲劳测试-杆；疲劳测试-螺钉；疲劳测试-外科植入物；矫形医疗设备-板；矫形医疗设备-杆；矫形医疗设备-螺钉；矫形脊柱设备；性能；脊柱关节成形术；外科设备；术语；测试方法-外科植入物

(Mandatory Information) (必填信息）

A1.1.1 This specification describes metallic spinal screws that are used as anchor elements in spinal arthrodesis implants for the surgical fixation of the skeletal spinal system.
A1.1.1 本规范描述在脊柱关节固定植入物中用作锚固件的金属脊柱螺钉，用于骨骼脊柱系统的手术固定。

A1.2.1 Classify spinal screws according to the classification methods identified in Specification F543.
A1.2.1 根据规范 F543 中确定的分类方法对脊柱螺钉进行分类。

A1.2.2 Spinal screws can also be classified with regard to the screw’s interconnecting capabilities with other spinal fixation system components such as expansion head, locking, and self-locking.
A1.2.2 脊柱螺钉还可根据螺钉与其他脊柱固定系统组件（如膨胀头、锁定和自锁）的相互连接能力进行分类。

A1.3.1 Dimensions of spinal screws shall follow the nomenclature established in Section 3.
A1.3.1 脊柱螺钉的尺寸应遵循第 3 节中规定的术语。

A1.3.2 In addition to the requirements of Section 6, add the screw diameter on the spinal screw labeling (when size permits).
A1.3.2 除第 6 节的要求外，在脊柱螺钉标签上增加螺钉直径（尺寸允许时）。

A1.3.3 In addition to the packaging information contained in Section 6, include the screw diameter and screw length.
A1.3.3 除第 6 节所载包装信息外，还应包括螺杆直径和螺杆长度。

A1.4.1 Select spinal screw materials in accordance with the requirements and recommendations of Section 7.
A1.4.1 根据第 7 节的要求和建议选择脊柱螺钉材料。

A1.5.1 Drive Connection-Suggested drive recesses for spinal screws can be found in Specification F543, Annex A6.
A1.5.1 传动连接-脊柱螺钉的建议传动凹槽见规格 F543，附件 A6。
A1.5.2 Torsion Properties-Determine the screw’s torsion strength characteristics (torsional yield moment, maximum torque, and breaking angle) using the test method of Specification F543. Annex A1.
A1.5.2 扭转特性-使用规范 F543 的试验方法确定螺钉的扭转强度特性（扭转屈服力矩、最大扭矩和断裂角）。附件 A1.

A1.5.3 Driving Torque Requirements-Determine the driving torque requirements (insertion and removal torque) for self-tapping and self-drilling spinal screws according to the test method found in Specification F543, Annex A2 with the following conditional requirements:
A1.5.3 驱动扭矩要求--根据规格 F543 附件 A2 中的试验方法，确定自攻和自钻脊柱螺钉的驱动扭矩要求（插入和拆除扭矩），并附带以下条件要求：

A1.5.3.1 Manufacture the test blocks from Grade 20, Specification F1839 rigid polyurethane foam whose length is no less than the insertion depth of the test being conducted.
A1.5.3.1 用规格为 F1839 的 20 级硬质聚氨酯泡沫塑料制造试块，其长度不小于所进行试验的插入深度。

A1.5.3.2 Conduct the driving torque tests at a motor speed of $30\mathrm{r}/\min$$30\mathrm{r}/\min$30r//min30 \mathrm{r} / \mathrm{min}.
A1.5.3.2 在 $30\mathrm{r}/\min$$30\mathrm{r}/\min$30r//min30 \mathrm{r} / \mathrm{min} 电机转速下进行驱动扭矩试验。

A1.5.3.3 Specific Screw Performance Tests-Measure the driving torque of the longest length spinal screw of a given design until the insertion depth is equal to the screw’s thread length.
A1.5.3.3 特定螺钉性能试验--测量特定设计的最长螺钉的驱动扭矩，直到插入深度等于螺钉的螺纹长度。

A1.5.3.4 Comparative Screw Performance Tests-Measure the driving torque until an insertion depth is reached that is equal to the shortest maximum screw thread length possible for the screw designs being compared.
A1.5.3.4 螺钉性能比较试验-测量驱动扭矩，直到插入深度等于所比较的螺钉设计可能的最短最大螺纹长度。

A1.5.4 Axial Pull-Out Load-Determine the screw’s axial pull-out load using the standard test method of Specification F543, Annex A3 with the following conditional requirements:
A1.5.4 轴向拉出载荷-使用规范 F543 附件 A3 的标准测试方法确定螺钉的轴向拉出载荷，并满足以下条件要求：

A1.5.4.1 Manufacture the test blocks from Grade 20, Specification F1839 rigid polyurethane foam.
A1.5.4.1 用规格为 F1839 的 20 级硬质聚氨酯泡沫塑料制造试块。

A1.5.4.2 Insert each screw into the test block at a motor speed of $30\mathrm{r}/\min$$30\mathrm{r}/\min$30r//min30 \mathrm{r} / \mathrm{min}.
A1.5.4.2 以 $30\mathrm{r}/\min$$30\mathrm{r}/\min$30r//min30 \mathrm{r} / \mathrm{min} 的电机速度将每个螺钉插入试块。

A1.5.4.3 Specific Screw Performance Tests-Insert the shortest spinal screw of a given design until the insertion depth is equal to the screw’s thread length.
A1.5.4.3 特定螺钉性能试验-插入特定设计的最短脊柱螺钉，直到插入深度等于螺钉的螺纹长度。

A1.5.4.4 Comparative Screw Performance Tests-Insert each spinal screw until an insertion depth is reached that is equal to the shortest maximum screw thread length possible for the screw designs being compared.
A1.5.4.4 螺钉性能比较试验--插入每根脊柱螺钉，直到插入深度等于所比较的螺钉设计可能的最短螺纹长度。
A1.5.5 Bending Properties-Determine the screw’s bending structural stiffness, bending yield moment, bending ultimate moment, bending fatigue runout moment, and when applicable, the median fatigue bending moment at 2500000 cycles using the test methods described in Annex A4.
A1.5.5 弯曲性能--采用附件 A4 中所述的试验方法，确定螺钉的弯曲结构刚度、弯曲屈服力矩、弯曲极限力矩、弯曲疲劳跳动力矩，并在适用情况下，确定 2500000 次循环时的疲劳弯曲力矩中值。

A2.1.1 This specification describes metallic spinal plates that are used as longitudinal elements in spinal arthrodesis implants for the surgical fixation of the skeletal spinal system.
A2.1.1 本规范描述了在脊柱关节固定植入物中用作纵向元件的金属脊柱板，用于骨骼脊柱系统的手术固定。

A2.2.1 Plates intended for spinal applications can be classified with regard to the following characteristics:
A2.2.1 用于脊柱的钢板可根据以下特征进行分类：

A2.2.2 Preferred Anatomic Location-The spinal region where the plate is indicated (such as cervical, thoracic, lumbar, and sacral) and position (anterior versus posterior).
A2.2.2 首选的解剖位置--指示钢板的脊柱区域（如颈椎、胸椎、腰椎和骶椎）和位置（前方或后方）。

A2.2.3 Preferred Use Limited to Specific Procedures-The type of surgical procedure where the plate is indicated (such as reconstruction, trauma, deformity, degenerative).
A2.2.3 限于特定手术的优先使用--钢板适用的手术类型（如重建、创伤、畸形、退行性变）。

A2.3.1 Dimensions of bone plates shall follow the nomenclature established in Section 3.
A2.3.1 骨板的尺寸应遵循第 3 节中规定的术语。

A2.3.2 In addition to the requirements of Section 6, include the plate length on spinal plate labeling.
A2.3.2 除第 6 节的要求外，还要在脊板标签上标明板长。

A2.4.1 Select spinal plate materials in accordance with the requirements and recommendations of Section 7.
A2.4.1 根据第 7 节的要求和建议选择脊板材料。

A2.5.1 Determine the spinal plate’s bending structural stiffness, bending yield moment, bending ultimate moment, bending fatigue runout moment, and, when applicable, the median bending fatigue moment at 2500000 cycles using the methods of Specification F382 and in accordance with the following requirements.
A2.5.1 使用规范 F382 的方法并按照以下要求确定脊板的弯曲结构刚度、弯曲屈服力矩、弯曲极限力矩、弯曲疲劳跳动力矩，并在适用情况下确定 2500000 次循环时的弯曲疲劳力矩中值。

A2.5.2 Configure the four-point bending test fixtures so that the loading rollers (inner rollers that are located dimension “a” apart) are positioned in accordance with the requirements of Table A2.1 (see also Fig. A2.1).
A2.5.2 配置四点弯曲试验夹具，使加载辊（相距尺寸 "a "的内辊）的位置符合表 A2.1 的要求（另见图 A2.1）。

TABLE A2.1 表 A2.1

A2.5.3 Position the test fixture support rollers (outer rollers that are located dimension “h” from the nearest loading roller) far enough away from the loading rollers so that the test article is free to respond to the applied bending moment (see Fig. A2.1). Under ideal conditions, position the support rollers in accordance with the recommended dimensions of Table A2.1. The dimension “h” may be reduced to $\mathrm{a}/2$$\mathrm{a}/2$a//2\mathrm{a} / 2 in order to accomodate testing of shorter plates, but this condition must be documented in the final report.
A2.5.3 将试验夹具的支撑辊（距离最近的加载辊尺寸为 "h "的外辊）放置在离加载辊足够远的位置，以便试验件可以自由地对施加的弯矩做出反应（见图 A2.1）。在理想条件下，支撑辊的位置应符合表 A2.1 的建议尺寸。尺寸 "h "可减小到 $\mathrm{a}/2$$\mathrm{a}/2$a//2\mathrm{a} / 2 以适应较短板材的测试，但这种情况必须记录在最终报告中。

A2.5.4 Maintain the test fixture configuration consistent for comparative tests.
A2.5.4 在比较试验中保持试验夹具配置一致。

A2.5.5 Only unused and untested specimens shall be included in the sample for a given spinal plate design. Include only final form and finished components in the sample.
A2.5.5 特定脊板设计的样品中只能包括未使用和未测试的试样。样品中只包括最终形状和成品部件。

A2.5.6 The sample size used for static tests shall be determined according to the methods defined in Practice E122 for any given loading condition. If insufficient information is available to determine a suitable sample size with Practice E122, use a minimum sample size of five.
A2.5.6 对于任何给定的加载条件，静态试验所用的样本量应根据试验规程 E122 规定的方法确定。如果没有足够的资料按 "规程 E122 "确定合适的样本量，则最少使用五个样本量。

A2.5.7 Load the test specimen during static tests at a displacement rate not to exceed $10\mathrm{mm}/\min$$10\mathrm{mm}/\min$10mm//min10 \mathrm{~mm} / \mathrm{min}.
A2.5.7 在静态试验中，以不超过 $10\mathrm{mm}/\min$$10\mathrm{mm}/\min$10mm//min10 \mathrm{~mm} / \mathrm{min} 的位移速率对试验试样加载。

A2.5.8 Test at least two specimens at each of three different maximum moment levels. One of the three maximum moment levels shall satisfy the maximum runout moment condition. Several references have been compiled that can provide the user with guidance and recommendations for selecting suitable sample sizes for fatigue studies used to develop an $M-N$$M-N$M-NM-N diagram. (1 and 2) ${}^4$${}^4$^(4){ }^{4}
A2.5.8 在三个不同的最大力矩水平下，每个水平至少试验两个试样。三个最大力矩水平中必须有一个满足最大跳动力矩条件。已汇编了一些参考文献，可为用户提供指导和建议，以便为疲劳研究选择合适的样本大小，用于绘制 $M-N$$M-N$M-NM-N 图。(1 和 2) ${}^4$${}^4$^(4){ }^{4}

A2.5.9 Conduct the recommended fatigue test in a laboratory air environment at room temperature. Other test environments (simulated body fluid, $9-\mathrm{g}\mathrm{NaCl}$$9-\mathrm{g}\mathrm{NaCl}$9-gNaCl9-\mathrm{g} \mathrm{NaCl} per 1000 mL water saline, a saline drip, or water) may be used while testing, but the suitability of using the respective test environment must be justified, given the accelerated nature of the laboratory fatigue test. If an alternative test environment is used, record all pertinent parameters related to the environmental conditions
A2.5.9 在实验室室温空气环境中进行建议的疲劳试验。试验时可使用其他试验环境（模拟体液、 $9-\mathrm{g}\mathrm{NaCl}$$9-\mathrm{g}\mathrm{NaCl}$9-gNaCl9-\mathrm{g} \mathrm{NaCl} 每1000毫升生理盐水、生理盐水滴注或水），但鉴于实验室疲劳试验的加速性质，必须证明使用相应试验环境的适宜性。如果使用其他试验环境，应记录与环境条件有关的所有参数

FIG. A2.1 Spinal Plate Test Configuration
图 A2.1 脊骨板测试配置
(temperature, pH , solution strengths, and so forth) before, during, and after the test.
(温度、pH 值、溶液强度等）。

A2.5.10 Apply sinusoidal cyclic loads in load control at an $R$$R$RR ratio of 0.10 for testing of devices intended for either the lumbar and thoracic spine regions. Apply sinusoidal cyclic loads in load control at an $R$$R$RR ratio of -1.0 for testing of devices intended for the cervical spine region. Fig. A2.2 illustrates a test setup for spinal plates that is capable of applying fully reversed loads ( $R=-1$$R=-1$R=-1R=-1 ). Other $R$$R$RR ratios may be used but must be documented in the report.
A2.5.10 用于腰椎和胸椎部位的设备测试时，在载荷控制中以 $R$$R$RR 0.10 的比率施加正弦循环载荷。测试颈椎部位的设备时，在负载控制中施加正弦周期负载， $R$$R$RR 比率为-1.0。图 A2.2 展示了能够施加完全反向负载 ( $R=-1$$R=-1$R=-1R=-1 ) 的脊柱板测试装置。可以使用其他 $R$$R$RR 比率，但必须在报告中记录。

A2.5.11 The user shall determine the frequency at which to conduct the fatigue test, but the maximum frequency of cyclic loading shall be 30 Hz .
A2.5.11 用户应确定进行疲劳试验的频率，但循环加载的最大频率应为 30 赫兹。
A2.5.12 Initial fatigue maximum moment levels that are 75, 50 , and $25\mathrm{\%}$$25\mathrm{\%}$25%25 \% of the bending ultimate moment determined with the static test method are suggested for the fatigue study. One maximum moment level should have specimens that do not fail before 2500000 cycles. The difference between the maximum moment value resulting in specimen failure and the maximum runout moment value must be less than $10\mathrm{\%}$$10\mathrm{\%}$10%10 \% of the device’s bending ultimate moment.
A2.5.12 建议在疲劳研究中采用静态试验方法确定的弯曲极限力矩的 75、50 和 $25\mathrm{\%}$$25\mathrm{\%}$25%25 \% 的初始疲劳最大力矩水平。在一个最大力矩水平上，试样应在 2500000 次循环之前不失效。导致试样失效的最大力矩值与最大跳动力矩值之间的差值必须小于设备弯曲极限力矩的 $10\mathrm{\%}$$10\mathrm{\%}$10%10 \% 。

FIG. A2.2 Spinal Plate Test Configuration, $R=-1$$R=-1$R=-1R=-1 Loading
图 A2.2 脊柱板测试配置， $R=-1$$R=-1$R=-1R=-1 加载

A3.1.1 This specification describes spinal rods that are used as longitudinal elements in spinal arthrodesis implants for the surgical fixation of the skeletal spinal system.
A3.1.1 本规范描述了在脊柱关节固定植入物中用作纵向元件的脊柱杆，用于骨骼脊柱系统的手术固定。

A3.2.1 Spinal rods indicated for spinal applications can be classified with regard to the following characteristics:
A3.2.1 用于脊柱的脊柱棒可根据以下特征进行分类：

A3.2.2 Preferred Anatomic Location-The spinal region where the rod is indicated (such as cervical, thoracic, lumbar, and sacral) and position (anterior versus posterior).
A3.2.2 首选的解剖位置--指示使用棒的脊柱区域（如颈椎、胸椎、腰椎和骶椎）和位置（前位或后位）。

A3.2.3 Preferred Use Limited to Specific Procedures-The type of surgical procedure where the rod is indicated (such as reconstruction, trauma, deformity, degenerative).
A3.2.3 限于特定手术的优先使用--适用于该棒的手术类型（如重建、创伤、畸形、退行性变）。

A3.3.1 Dimensions of spinal rods shall follow the nomenclature established in Section 3.
A3.3.1 脊骨棒的尺寸应遵循第 3 节中规定的术语。

A3.3.2 In addition to the requirements of Section 6, include the rod diameter and rod length on spinal rod labeling.
A3.3.2 除第 6 节的要求外，还要在脊柱杆标签上注明杆直径和杆长度。

A3.4.1 Select spinal rod materials in accordance with the requirements and recommendations of Section 7.
A3.4.1 根据第 7 节的要求和建议选择脊柱杆材料。

A3.5.1 Determine the spinal rod’s bending structural stiffness, bending yield moment, bending ultimate moment, bending fatigue runout moment, and when applicable, the median bending fatigue moment at 2500000 cycles using the methods of Specification F382 and in accordance with the following requirements.
A3.5.1 使用规范 F382 的方法并按照以下要求确定脊柱杆的弯曲结构刚度、弯曲屈服力矩、弯曲极限力矩、弯曲疲劳跳动力矩，并在适用情况下确定 2500000 次循环时的弯曲疲劳力矩中值。

A3.5.2 Fit the test fixture with ${90}^{\circ }$${90}^{\circ }$90^(@)90^{\circ} “V” alignment notched rollers. This roller profile will allow the testing of a range of rod sizes with a single roller set. Such rollers will also prevent the application of the load at the most highly stressed point on the circumference of the rod.
A3.5.2 在测试夹具上安装 ${90}^{\circ }$${90}^{\circ }$90^(@)90^{\circ} "V "型对齐凹槽滚轮。这种辊轮轮廓允许使用单个辊轮组测试各种尺寸的杆。这种滚轮还可以防止在杆圆周上应力最大的点施加载荷。

A3.5.3 Configure the four-point bending test fixtures so that the loading rollers (inner rollers that are located dimension " $a$$a$aa " apart) are positioned in accordance with the requirements of Table A2.1 (see also Fig. A3.1).
A3.5.3 配置四点弯曲试验夹具，使加载辊（相距尺寸为 " $a$$a$aa " 的内辊）的位置符合表 A2.1 的要求（另见图 A3.1）。

A3.5.4 Position the test fixture support rollers (outer rollers that are located dimension “h” from the nearest loading roller) in accordance with the recommended dimensions of Table A2.1.
A3.5.4 按照表 A2.1 中的推荐尺寸定位试验夹具支撑辊（与最近的加载辊的距离尺寸为 "h "的外辊）。

A3.5.5 Maintain the test fixture configuration consistent for comparative tests.
A3.5.5 在比较试验中保持试验夹具配置的一致性。

A3.5.6 Only unused and untested specimens shall be included in the sample for a given spinal plate design. Include only final form and finished components in the sample.
A3.5.6 特定脊板设计的样品中只能包括未使用和未测试的试样。样品中仅包括最终形状和成品部件。

A3.5.7 The sample size used for static tests shall be determined according to the methods defined in Practice E122 for any given loading condition. If insufficient information is available to determine a suitable sample size with Practice E122, use a minimum sample size of five.
A3.5.7 静态试验所用的样本量，应根据 "规程E122 "对任何给定加载条件所规定的方法确定。如果没有足够的资料按 "规程E122 "确定合适的样本量，则最少使用5个样本量。

A3.5.8 Load the test specimen during static tests at a displacement rate not exceeding $10\mathrm{mm}/\min$$10\mathrm{mm}/\min$10mm//min10 \mathrm{~mm} / \mathrm{min}.
A3.5.8 在静态试验中，以不超过 $10\mathrm{mm}/\min$$10\mathrm{mm}/\min$10mm//min10 \mathrm{~mm} / \mathrm{min} 的位移速率对试验试样加载。

A3.5.9 For fatigue studies, test at least two specimens at each of three different maximum moment levels. One of the three maximum moment levels shall satisfy the maximum runout moment condition. Several references have be compiled that can provide the user with guidance and recommendations for selecting suitable sample sizes for fatigue studies used to develop an $M-N$$M-N$M-NM-N diagram. (1 and 2)
A3.5.9 对于疲劳研究，在三个不同的最大力矩水平下至少各测试两个试样。三个最大力矩水平中必须有一个满足最大跳动力矩条件。我们汇编了一些参考文献，可为用户提供指导和建议，帮助他们为疲劳研究选择合适的样本大小，用于绘制 $M-N$$M-N$M-NM-N 图。(1 和 2)

FIG. A3.1 Spinal Rod Test Configuration
图 A3.1 脊髓棒测试配置

A3.5.10 Conduct the recommended fatigue test in a laboratory air environment at room temperature. Other test environments (simulated body fluid, $9-\mathrm{g}\mathrm{NaCl}$$9-\mathrm{g}\mathrm{NaCl}$9-gNaCl9-\mathrm{g} \mathrm{NaCl} per 1000 mL water saline, a saline drip, or water) may be used while testing, but the suitability of using the respective test environment must be justified, given the accelerated nature of the laboratory fatigue test. If an alternative test environment is used, record all pertinent parameters related to the environmental conditions (temperature, pH , solution strengths, and so forth) before, during, and after the test.
A3.5.10 在实验室室温空气环境中进行建议的疲劳试验。试验时可使用其他试验环境（模拟体液、 $9-\mathrm{g}\mathrm{NaCl}$$9-\mathrm{g}\mathrm{NaCl}$9-gNaCl9-\mathrm{g} \mathrm{NaCl} 每1000毫升生理盐水、生理盐水滴注或水），但鉴于实验室疲劳试验的加速性质，必须证明使用相应试验环境的适宜性。如果使用其他测试环境，应记录测试前、测试中和测试后与环境条件（温度、 pH 值、溶液强度等）有关的所有参数。

A3.5.11 Apply sinusoidal cyclic loads in load control at an $R$$R$RR ratio of 0.10 for testing of devices intended for either the lumbar and thoracic spine regions. Apply sinusoidal cyclic loads in load control at an $R$$R$RR ratio of -1.0 for testing of devices intended for the cervical spine region. Fig. A2.2 illustrates a test setup for spinal plates that can be similarly adapted in order to apply fully reversed loads $(R=-1)$$(R=-1)$(R=-1)(R=-1) to spinal rods. Other $R$$R$RR ratios may be used but must be documented in the report.
A3.5.11 用于腰椎和胸椎部位的设备测试时，在载荷控制中以 $R$$R$RR 0.10 的比率施加正弦循环载荷。在测试颈椎区域的装置时，在负载控制中以 $R$$R$RR 比率-1.0施加正弦周期负载。图 A2.2 展示了脊柱板的测试装置，可进行类似调整，以便对脊柱杆施加完全反向的 $(R=-1)$$(R=-1)$(R=-1)(R=-1) 负载。也可使用其他 $R$$R$RR 比率，但必须在报告中记录。

A3.5.12 The user shall determine the frequency at which to conduct the fatigue test, but the maximum recommended frequency of cyclic loading shall be 30 Hz .
A3.5.12 用户应确定进行疲劳试验的频率，但建议循环加载的最大频率应为 30 赫兹。

A3.5.13 Initial fatigue maximum moment levels that are 75, 50 , and $25\mathrm{\%}$$25\mathrm{\%}$25%25 \% of the bending ultimate moment determined with the static test method are suggested for the fatigue study. One maximum moment level should have specimens that do not fail before 2500000 cycles. The difference between the maximum moment value resulting in specimen failure and the maximum runout moment value must be less than $10\mathrm{\%}$$10\mathrm{\%}$10%10 \% of the device’s bending ultimate moment.
A3.5.13 建议在疲劳研究中采用静态试验方法确定的弯曲极限力矩的75、50和 $25\mathrm{\%}$$25\mathrm{\%}$25%25 \% 的初始疲劳最大力矩水平。在一个最大力矩水平上，试样应在 2500000 次循环之前不失效。导致试样失效的最大力矩值与最大跳动力矩值之间的差值必须小于设备弯曲极限力矩的 $10\mathrm{\%}$$10\mathrm{\%}$10%10 \% 。

A4.1.1 This test method describes the methods for determining the static and dynamic bending properties of metallic spinal screws that are used in spinal arthrodesis implants.
A4.1.1 本试验方法描述了测定用于脊柱关节置换植入物的金属脊柱螺钉的静态和动态弯曲特性的方法。

A4.1.2 This test method is intended to provide a means of mechanically characterizing different component designs of spinal screws. It is not the intention of this test method to define levels of performance of spinal screws since insufficient information is available to predict the consequences of the use of a particular screw design.
A4.1.2 本试验方法旨在提供一种方法，对脊柱螺钉的不同组件设计进行机械鉴定。本测试方法无意定义脊柱螺钉的性能水平，因为没有足够的信息来预测使用特定螺钉设计的后果。

A4.2.1 Spinal screws are loaded in quasi-static cantilever bending in order to record the component’s mechanical response to the applied load. The load-versus-deflection curve is then analyzed in order to determine data used to derive the remaining bending properties of the spinal screw.
A4.2.1 在准静态悬臂弯曲中加载脊柱螺钉，以记录部件对施加载荷的机械响应。然后分析载荷-挠度曲线，以确定用于推导脊柱螺钉剩余弯曲特性的数据。

A4.2.2 Samples of a given spinal screw are loaded under cantilever bending in a sinusoidal cyclic manner at a predetermined frequency. The fatigue loading is continued until the specimen fails, a limit is reached which terminates the test, or until a predetermined cycle count (runout limit) is reached. The resulting test information is then used to develop a moment versus number of cycles curve that will characterize the general fatigue behavior for the given spinal screw design over a range of applied bending moments. Additionally, the information can be used, when applicable, to determine the spinal screw’s median bending fatigue moment determined for a specified $N$$N$NN number of cycles.
A4.2.2 在悬臂弯曲状态下，以预定频率正弦循环加载特定脊柱螺钉样品。疲劳加载一直持续到试样失效、达到终止试验的极限或达到预定的循环次数（跳动极限）为止。测试结果信息可用于绘制弯矩与循环次数的曲线，该曲线将描述特定椎弓螺钉设计在一定范围的外加弯矩下的一般疲劳行为。此外，在适用的情况下，这些信息还可用于确定脊柱螺钉在指定 $N$$N$NN 循环次数下的中位弯曲疲劳力矩。

A4.3.1 This test method establishes a uniform static and dynamic bending test that will characterize, and can be used to compare, the static bending characteristics and fatigue performance of different designs of spinal screws. This test method is used to determine a spinal screw’s fatigue life over a range of maximum bending moment conditions. Additionally, the method may be used to estimate the spinal screw’s fatigue characteristics for a specified number of fatigue cycles.
A4.3.1 本试验方法规定了统一的静态和动态弯曲试验，可鉴定并用于比较不同设计的脊柱螺钉的静态弯曲特性和疲劳性能。该测试方法用于确定脊柱螺钉在一系列最大弯矩条件下的疲劳寿命。此外，该方法还可用于估算脊柱螺钉在特定疲劳循环次数下的疲劳特性。

A4.3.2 Spinal screws are integral components of many spinal implant constructs. They are designed to anchor the longitudinal or transverse elements, or both, to the bone. This test method defines standard equivalent test methods that can be used when evaluating different designs of spinal screws.
A4.3.2 脊柱螺钉是许多脊柱植入物结构的组成部分。其设计目的是将纵向或横向元件或两者都固定在骨骼上。本测试方法定义了标准等效测试方法，可用于评估脊柱螺钉的不同设计。

A4.3.3 This test method assumes that the spinal screw is manufactured from a material that exhibits linear-elastic material behavior. Therefore, the test method is not applicable for testing spinal screws made from materials that exhibit nonlinear elastic behavior.
A4.3.3 本试验方法假定脊柱螺钉是由表现出线性弹性材料行为的材料制造的。因此，该测试方法不适用于测试由表现出非线性弹性行为的材料制成的脊柱螺钉。

A4.3.4 The fatigue test method described in this document is restricted to the testing of the spinal screw within the material’s linear-elastic range. Therefore, the fatigue test method is not applicable for testing spinal screws under conditions that would approach or exceed the bending strength of the spinal screw being tested.
A4.3.4 本文件所述的疲劳试验方法仅限于在材料的线弹性范围内对脊柱螺钉进行试验。因此，疲劳测试方法不适用于在接近或超过被测脊柱螺钉弯曲强度的条件下测试脊柱螺钉。

A4.3.5 The reporting of static and fatigue bending properties determined by this testing technique are only suitable for comparative evaluations between screws of different sizes, designs, and materials.
A4.3.5 通过该测试技术确定的静态和疲劳弯曲特性报告仅适用于不同尺寸、设计和材料的螺钉之间的比较评估。

A4.4.1 Axial Load Frame-A test machine capable of applying tensile or compressive loads at a constant displacement rate.
A4.4.1 轴向载荷框架--能以恒定位移速率施加拉伸或压缩载荷的试验机。

A4.4.2 Force Transducer-A calibrated sensor capable of measuring axial loads per the requirements of Practice E4, and providing an output readable by a suitable recording device.
A4.4.2 力传感器--经过校准的传感器，能够按照规范 E4 的要求测量轴向载荷，并提供可由适当记录装置读取的输出。

A4.4.3 Displacement Transducer-A calibrated sensor capable of measuring axial displacements with an accuracy of $\pm 1\mathrm{\%}$$\pm 1\mathrm{\%}$+-1%\pm 1 \% of its full scale range, and providing an output readable by a suitable recording device.
A4.4.3 位移传感器 -- 经过校准的传感器，能够测量轴向位移，精度为其满量程的 $\pm 1\mathrm{\%}$$\pm 1\mathrm{\%}$+-1%\pm 1 \% ，并提供可由适当记录装置读取的输出。

A4.4.4 Recording Device-A calibrated recording device capable of monitoring the output of the force and displacement transducers and capable of generating a force versus displacement curve.
A4.4.4 记录装置--经过校准的记录装置，能够监测力和位移传感器的输出，并能生成力与位移的曲线。
A4.4.5 The suitability of any data acquisition system used in monitoring the progress of these tests should be evaluated in accordance with the guidelines of Guide E1942.
A4.4.5 应根据《E1942 指南》的准则评估用于监测这些试验进展的任何数据采集系统的适用性。

A4.4.6 Force Transducer-A calibrated sensor capable of measuring dynamic tensile or compressive loads, or both, in accordance with Practice E467.
A4.4.6 力传感器--按照规范 E467 校准的传感器，能够测量动态拉伸或压缩载荷或两者。
A4.4.7 Cycle Counter-A device capable of counting the number of loading cycles applied to a test sample during the course of a fatigue test.
A4.4.7 循环计数器（Cycle Counter）--能计算疲劳试验过程中加载到试验样品上的循环次数的装置。

A4.4.8 Limit-A device capable of detecting when a test parameter (for example, load, actuator displacement, DC error, and so forth) reaches a limiting value, at which time the test is stopped and the current cycle count is maintained.
A4.4.8 极限--当测试参数（如负载、执行器位移、直流误差等）达到极限值时，能 够检测到的装置，此时停止测试并保持当前的循环次数。

A4.4.9 The suitability of any data acquisition systems used in monitoring the progress of these tests should be evaluated in accordance with the guidelines of Guide E1942.
A4.4.9 应根据《E1942 指南》的准则评估用于监测这些试验进展的任何数据采集系统的适用性。

A4.4.10 Any test fixture implemented shall be sufficiently rigid so that its deformation under the maximum load is less than $1\mathrm{\%}$$1\mathrm{\%}$1%1 \% of the test sample’s deformation.
A4.4.10 使用的任何试验夹具必须具有足够的刚度，使其在最大载荷作用下的变形小于试验样品变形的 $1\mathrm{\%}$$1\mathrm{\%}$1%1 \% 。

A4.4.11 The threaded region of the spinal screw is embedded into a test block made from a synthetic material that is easily processed with standard spinal fixation system instruments. The user may manufacture a more rigid metallic test block (that is, hardened stainless steel at 40 HRC min.), if so desired, but may substitute Specification D4020 or Specification F648 UHMWPE or Grade 40, Specification F1839 rigid polyurethane foam, for the test block material.
A4.4.11 脊柱螺钉的螺纹区域嵌入由合成材料制成的试验块中，这种材料易于使用标准脊柱固定系统器械进行加工。用户可根据需要制造硬度更高的金属试块（即硬度不低于 40 HRC 的硬化不锈钢），但也可以用规格 D4020 或规格 F648 超高分子量聚乙烯或规格 F1839 的 40 级硬质聚氨酯泡沫代替试块材料。

A4.4.12 An anchoring fixture is rigidly attached to the spinal screw’s head so that the screw’s head is fully constrained during the test. The load is applied to the test sample at the end containing the test block, which is protected from localized failure by a protection sleeve placed around the test block. (See Fig. A4.2)
A4.4.12 锚定夹具与脊柱螺钉头部刚性连接，使螺钉头部在试验期间受到完全约束。载荷加在包含测试块的一端的测试样本上，测试块周围的保护套可防止局部失效。(见图 A4.2）

A4.5.1 Only unused and untested specimens shall be included in the sample for a given spinal component design. Include only final form and finished components in the sample.
A4.5.1 对于给定的脊柱部件设计，样品中只能包括未使用和未测试的试样。样品中只包括最终形状和成品部件。

A4.5.2 The sample size used for static tests shall be determined according to the methods defined in Practice E122 for any given loading condition. If insufficient information is available to determine a suitable sample size with Practice E122, then use a minimum sample size of five.
A4.5.2 对于任何给定的加载条件，静态试验所用的样本量应根据试验规程E122 中规定的方法确定。如果没有足够的资料可用 "规程E122 "确定合适的样本量，则最少使用5个样本量。

A4.5.3 For fatigue studies, test at least two specimens at each of three different maximum moment levels. One of the three maximum moment levels shall satisfy the maximum runout moment condition. Several references have been compiled that can provide the user with guidance and recommendations for selecting suitable sample sizes for fatigue studies used to develop an $M-N$$M-N$M-NM-N diagram. (1 and 2)
A4.5.3 对于疲劳研究，在三个不同的最大力矩水平下至少各测试两个试样。三个最大力矩水平中必须有一个满足最大跳动力矩条件。已汇编了一些参考资料，可为用户提供指导和建议，以便为疲劳研究选择合适的样本大小，用于绘制 $M-N$$M-N$M-NM-N 图。(1 和 2)

A4.5.4 Use spinal screws of sufficient length so that at least 5 mm of screw thread length is included in the exposed length (see Fig. A4.2).
A4.5.4 使用足够长的脊柱螺钉，使外露长度中至少包括 5 毫米的螺纹长度（见图 A4.2）。

A4.6.1 Manufacture test blocks so that the surface defined by the outside diameter of the screw is at least one screw thread diameter away from the test block’s outer surface and 10 mm long (measured in the direction of the screw’s longitudinal axis). Check to ensure that the test block surfaces are oriented
A4.6.1 制造试块，使螺钉外径确定的表面与试块外表面至少相差一个螺纹直径，长度为 10 毫米（沿螺钉纵轴方向测量）。检查试块表面的方向是否正确

so that the spinal screw’s undeflected longitudinal axis is aligned perpendicular to the direction of the applied load.
使脊柱螺钉的未变形纵轴垂直于施加载荷的方向。

A4.6.2 Drill pilot holes in the test block for insertion of the test specimen. The holes shall be drilled coincident to the test block’s longitudinal axis. The drill used shall be the size specified by the manufacturer for the specimen being tested. When testing self-drilling spinal screws, a pilot hole that is no larger than $75\mathrm{\%}$$75\mathrm{\%}$75%75 \% of the screw’s core diameter is recommended simply to ensure the screw’s orientation for testing. Drill the pilot hole straight and true at ${90}^{\circ }$${90}^{\circ }$90^(@)90^{\circ} to the surface of the test block that will be penetrated. Tapered holes are allowed when tapered screws are to be tested. Complete the test block’s hole preparation according to the given spinal screw’s surgical technique (such as tapping when required).
A4.6.2 在试块上钻导向孔，以便插入试样。钻孔应与试块的纵轴重合。所使用的钻头必须是制造商为所测试的试样规定的尺寸。测试自钻脊柱螺钉时，建议钻一个不大于螺钉芯直径 $75\mathrm{\%}$$75\mathrm{\%}$75%75 \% 的导向孔，以确保测试时螺钉的方向。在 ${90}^{\circ }$${90}^{\circ }$90^(@)90^{\circ} 处将导向孔钻直，并与要穿透的试块表面保持一致。测试锥形螺钉时，允许钻锥形孔。根据特定脊柱螺钉的手术技术完成测试块的孔准备工作（如需要时进行攻丝）。

A4.6.3 Insert the test sample into the test block to a depth of approximately 10 mm to create the same moment arm $(L)$$(L)$(L)(L) for all screws having the same nominal length. For screws whose nominal length is less than 30 mm , inset the screw until
A4.6.3 将测试样本插入测试块，深度约为 10 毫米，以便为所有具有相同标称长度的螺钉创建相同的力矩臂 $(L)$$(L)$(L)(L) 。对于标称长度小于 30 毫米的螺钉，插入螺钉直至
one-third the length of the screw (measured from the longitudinal element interconnection and the screw’s tip) is engaged in the test block.
螺杆长度的三分之一（从纵向元件连接处和螺杆顶端测量）啮合在试块上。

A4.6.4 Mount the test sample in the test machine so that the screw’s head is rigidly constrained as illustrated in Fig. A4.2. The test fixture depicted in Fig. A4.2 can be modified so that the interconnection mechanism can be used for anchoring the screw.
A4.6.4 如图A4.2 所示，将试验样品安装在试验机中，使螺钉头部受到刚性约束。图 A4.2 所示的试验夹具可以改装，以便使用互联机构固定螺钉。

A4.6.5 Position the test setup so that the load is applied to the center of the test block, 5 mm from each end. The bending moment arm $(L)$$(L)$(L)(L) shall be held constant for all diameter screws of a given length. Install the protection sleeve over the test block.
A4.6.5 放置试验装置，使载荷作用在试验块的中心，两端各距 5 毫米。对于给定长度的所有直径螺钉，弯矩臂 $(L)$$(L)$(L)(L) 应保持恒定。在试块上安装保护套。

A4.6.6 Record the exposed length and bending moment arm $(L)$$(L)$(L)(L) for the final test setup.
A4.6.6 记录最终测试装置的外露长度和弯矩臂 $(L)$$(L)$(L)(L) 。

A4.7.1 Apply loads of increasing magnitude (in displacement control), and generate a load-versus-displacement diagram either automatically or from numeric data acquired during the test. Bending characteristics shall be measured using the apparatus described in A4.4.
A4.7.1 （在位移控制条件下）施加越来越大的荷载，并自动或根据试验过程中获 得的数值数据生成荷载与位移的关系图。应使用 A4.4 所述仪器测量弯曲特性。

A4.7.2 Load the test specimen at a displacement rate not exceeding $25\mathrm{mm}/\min$$25\mathrm{mm}/\min$25mm//min25 \mathrm{~mm} / \mathrm{min}. Continue loading the test specimen until the slope of the load-versus-displacement curve, beyond the linear elastic region, changes “sign.”
A4.7.2 以不超过 $25\mathrm{mm}/\min$$25\mathrm{mm}/\min$25mm//min25 \mathrm{~mm} / \mathrm{min} 的位移速率加载试样。继续加载试样，直至线性弹性区域以外的荷载-位移曲线斜率 "符号 "发生变化。

A4.7.3 Unload the test specimen and record the failure location and failure mode, if applicable.
A4.7.3 卸载试验试样并记录失效位置和失效模式（如适用）。

A4.7.4 Conduct the recommended fatigue test in a laboratory air environment at room temperature. Other test environments (simulated body fluid, $9-\mathrm{g}\mathrm{NaCl}$$9-\mathrm{g}\mathrm{NaCl}$9-gNaCl9-\mathrm{g} \mathrm{NaCl} per 1000 mL water saline, a saline drip, or water) may be used while testing, but the suitability of using the respective test environment must be justified, given the accelerated nature of the laboratory fatigue test. If an alternative test environment is used, record all pertinent parameters related to the environmental conditions (temperature, pH , solution strengths, and so forth) before, during, and after the test.
A4.7.4 在实验室室温空气环境中进行建议的疲劳试验。试验时可使用其他试验环境（模拟体液、 $9-\mathrm{g}\mathrm{NaCl}$$9-\mathrm{g}\mathrm{NaCl}$9-gNaCl9-\mathrm{g} \mathrm{NaCl} 每1000毫升生理盐水、生理盐水滴注或水），但鉴于实验室疲劳试验的加速性质，必须证明使用相应试验环境的适宜性。如果使用其他试验环境，应记录试验前、试验中和试验后与环境条件（温度、 pH 值、溶液强度等）有关的所有参数。
A4.7.5 Apply sinusoidal cyclic loads in load control at an $R$$R$RR ratio of 0.10 for testing of devices intended for either the lumbar or thoracic spine regions. Apply sinusoidal cyclic loads in load control at an $R$$R$RR ratio of -1.0 for testing of devices intended for the cervical spine region. Other $R$$R$RR ratios may be used but must be documented in the report.
A4.7.5 用于腰椎或胸椎部位的设备测试时，在载荷控制中以 $R$$R$RR 0.10 的比率施加正弦循环载荷。在负载控制中施加正弦周期负载， $R$$R$RR 比率为-1.0，用于测试颈椎区域的设备。也可使用其他 $R$$R$RR 比率，但必须在报告中记录。
A4.7.6 The user shall determine the frequency at which to conduct the fatigue test, but the maximum recommended frequency of cyclic loading shall be 30 Hz .
A4.7.6 用户应确定进行疲劳试验的频率，但建议循环加载的最大频率应为 30 赫兹。

A4.7.7 Initial fatigue maximum moment levels that are 75, 50 , and $25\mathrm{\%}$$25\mathrm{\%}$25%25 \% of the bending ultimate moment determined with the static test method are suggested for the fatigue study. One maximum moment level should have specimens that do not fail before 2500000 cycles. The difference between the maximum moment value resulting in specimen failure and the maximum runout moment value must be less than $10\mathrm{\%}$$10\mathrm{\%}$10%10 \% of the device’s bending ultimate moment.
A4.7.7 建议在疲劳研究中采用静态试验方法确定的弯曲极限力矩的75、50和 $25\mathrm{\%}$$25\mathrm{\%}$25%25 \%