磷酸钙和金属涂层检测

GB/T 23807-2009精细陶瓷分类系统

本标准规定了精细陶瓷的分类。该系统包括陶瓷粉料前驱体、粉末、陶粒、纤维、晶须、片晶、单晶、多晶、非晶态(玻璃)材料，及复合材料、陶瓷薄膜、涂层。该分类系统将构成标准的核心。分类系统不包含以下：a 碳材料，除某些特殊陶瓷如金刚石、玻璃碳或者化学气相沉积石墨以外；b 硅材料，锗元素以及其他半金属材料，但它们作为精细陶瓷组成或前驱体时除外；c 粘土类传统陶瓷，包括：1 日用陶器(餐具等日用精细陶瓷制品)；2 建筑卫生陶瓷；3 墙体材料；d 定形的和不定形的耐火材料。本标准适用于精细陶瓷的分类。本标准不适用于硬质合金产品或者主要成分为玻璃的制品，但可以参照采用。本标准不是为了强制规范该分类系统如何使用，而是提供一个灵活框架和一个推荐性的可操作的编码系统，使用人员可以根据陶瓷产品信息编订编码。

YY 0118-2016关节置换植入物髋关节假体

本标准规定了部分和全髋关节假体的术语和定义、分类和尺寸标注、预期性能、设计属性、材料、设计评价、制造、灭菌、包装和制造商提供的信息的要求。本标准适用于使用本标准所规定的材料和工艺制造的部分和全髋关节假体。

YY 0502-2016关节置换植入物 膝关节假体

本标准规定了膝关节假体的术语和定义、分类和尺寸标注、预期性能、设计属性、材料、设计评价、制造、灭菌、包装和制造商提供的信息的要求。本标准适用于使用本标准所规定的材料和工艺制造的部分和全膝关节假体。

YY/T 0963-2014关节置换植入物 肩关节假体

本标准规定了关节置换植入物--肩关节假体的术语和定义、分类、材料、设计评价、制造、灭菌、包装、制造商应提供的信息。本标准适用于由关节盂部件和肱骨部件组成并提供功能性关节作用的部分或全肩关节假体。本标准不适用于定制型假体。组合式假体适用于本标准。

YY/T 0988.1-2016外科植入物涂层.第1部分:钴-28铬-6钼粉末

YY/T 0988的本部分规定了用于在钴-28铬-6钼植入物上形成涂层的钴-28铬-6钼合金粉末的要求。本部分所规定的粉末可通过烧结工艺或热喷涂工艺形成涂层。本部分规定了粉末的要求，不适用于粉末制成的涂层的性能。

YY/T 0988.2-2016外科植入物涂层 第2部分:钛及钛-6铝-4钒合金粉末

YY/T 0988的本部分规定了用在钛合金植入物上形成涂层的纯钛粉和钛-6铝-4钒合金粉末的要求。本部分所规定的粉末可通过烧结工艺或热喷涂工艺形成涂层。本部分规定了粉末的要求，不适用于粉末制成的涂层的性能。

YY/T 0988.11-2016外科植入物涂层.第11部分:磷酸钙涂层和金属涂层拉伸试验方法

YY/T 0988的本部分规定了在室温条件下覆盖在致密金属基体上的磷酸钙涂层和金属多孔涂层的拉伸试验方法。本部分用于评价在拉伸形式下(垂直于粘结平面方向上)涂层对基体的粘结程度或涂层内部的结合程度。本部分采用单位制(SI)。本部分并非试图对所涉及的所有安全问题进行阐述，即便是那些与其使用有关的安全问题。确立适当的安全及健康规范，以及在应用前明确管理限制的适用性，是本部分用户自身的责任。

YY/T 0988.12-2016外科植入物涂层 第12部分:磷酸钙涂层和金属涂层剪切试验方法

YY/T 0988的本部分规定了在室温条件下粘结在致密金属基体上的连续磷酸钙涂层和金属涂层的剪切试验方法。本部分用于评价在剪切形式下（平行于粘结平面方向上）涂层对基体的粘结程度或内部结合程度。本部分采用单位制（SI）。本部分并非试图对所涉及到的所有安全问题进行阐述，即便是那些与其使用有关的安全问题。确立适当的安全及健康规范，以及在应用前明确管理限制的适用性，是本部分的使用者自身的责任。

YY/T 0988.13-2016外科植入物涂层 第13部分:磷酸钙、金属和磷酸钙/金属复合涂层剪切和弯曲疲劳试验方法

YY/T 0988的本部分包含了确定磷酸钙涂层、多孔和非多孔金属涂层剪切和弯曲疲劳性能的试验方法，也包含了确定覆盖有磷酸钙的金属涂层弯曲疲劳性能的试验方法。本部分是基于等离子喷涂的钛涂层和等离子喷涂羟基磷灰石涂层所建立。本部分尚未建立对于其他涂层的效果。在剪切疲劳模式下本试验方法评价了覆盖金属基体上涂层的粘结性和结合性。在弯曲疲劳模式下本部分评价了涂层的粘结性以及涂层对基体材料的影响。这些试验方法仅在室温下空气中进行。

YY/T 0988.14-2016外科植入物涂层.第14部分:多孔涂层体视学评价方法

YY/T 0988的本部分包括了表征附着于无孔基体上的各种多孔涂层的涂层厚度、孔隙率和平均截距的体视学试验方法。9.4中概述了在多孔涂层厚度的不同层次“组织界面梯度”上孔隙率和截距的测量方法。8.2中的切向取样法不适用于9.4中的组织界而梯度法。本部分采用单位制(SI)。本部分并非试图对所涉及到的所有安全问题进行阐述，即便是那些与其使用有关的安全问题。确立适当的安全及健康规范，以及在应用前明确管理限制的适用性，是本标准用户自身的责任。

YY/T 0988.15-2016外科植入物涂层 第15部分:金属热喷涂涂层耐磨性能试验方法

YY/T 0988的本部分用于量化热喷涂方法喷涂在金属平面上的金属涂层的耐磨性能。本部分旨在为外科植入物用途层提供一种表征方法。本部分通过磨耗仪产生的滚动与摩擦的混合作用使涂层表面产生磨损。磨损通过累计质量损失进行量化。本试验方法仅用于平的刚性试样。试样不与水发生明显反应，在室温与100℃之间的空气中不发生相变及化学反应。本部分并非试图对所涉及到的所有安全问题进行阐述，即便是那些与其使用有关的安全问题。

ASTM F1160-2014磷酸钙和医用金属与复合磷酸钙/金属涂层的剪切和弯曲疲劳试验的标准试验方法

5.1x00a0;The shear and bending fatigue tests are used to determine the effect of variations in material, geometry, surface condition, stress, and so forth, on the fatigue resistance of coated metallic materials subjected to direct stress for up to 107 cycles. These tests may be used as a relative guide to the selection of coated materials for service under condition of repeated stress. 5.2x00a0;In order that such basic fatigue data be comparable, reproducible, and can be correlated among laboratories, it is essential that uniform fatigue practices be established. 5.3x00a0;The results of the fatigue test may be used for basic material property design. Actual components should not be tested using these test methods. 1.1x00a0;This test method covers the procedure for determining the shear and bending fatigue performance of calcium phosphate coatings and of porous and nonporous metallic coatings and for determining the bending fatigue performance of metallic coatings over sprayed with calcium phosphate. This test method has been established based on plasma-sprayed titanium and plasma-sprayed hydroxylapatite coatings. The efficacy of this test method for other coatings has not been established. In the shear fatigue mode, this test method evaluates the adhesive and cohesive properties of the coating on a metallic substrate. In the bending fatigue mode, this test method evaluates both the adhesion of the coating as well as the effects that the coating may have on the substrate material. These methods are limited to testing in air at ambient temperature. These test methods are not intended for application in fatigue tests of components or devices; however, the test method which most closely replicates the actual loading configuration is preferred. 1.2x00a0;The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 1.3x00a0;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.

ASTM F1160-2014(2017)e1磷酸钙和金属医用及复合磷酸钙/金属涂层剪切和弯曲疲劳试验的标准试验方法

5.1x00a0;The shear and bending fatigue tests are used to determine the effect of variations in material, geometry, surface condition, stress, and so forth, on the fatigue resistance of coated metallic materials subjected to direct stress for up to 107 cycles. These tests may be used as a relative guide to the selection of coated materials for service under condition of repeated stress. 5.2x00a0;In order that such basic fatigue data be comparable, reproducible, and can be correlated among laboratories, it is essential that uniform fatigue practices be established. 5.3x00a0;The results of the fatigue test may be used for basic material property design. Actual components should not be tested using these test methods. 1.1x00a0;This test method covers the procedure for determining the shear and bending fatigue performance of calcium phosphate coatings and of porous and nonporous metallic coatings and for determining the bending fatigue performance of metallic coatings over sprayed with calcium phosphate. This test method has been established based on plasma-sprayed titanium and plasma-sprayed hydroxylapatite coatings. The efficacy of this test method for other coatings has not been established. In the shear fatigue mode, this test method evaluates the adhesive and cohesive properties of the coating on a metallic substrate. In the bending fatigue mode, this test method evaluates both the adhesion of the coating as well as the effects that the coating may have on the substrate material. These methods are limited to testing in air at ambient temperature. These test methods are not intended for application in fatigue tests of components or devices; however, the test method which most closely replicates the actual loading configuration is preferred. 1.2x00a0;The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 1.3x00a0;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. 1.4x00a0;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.

ABNT NBR 15664-3-2011骨科植入物 - 产品涂层第3部分-测试确定剪切和弯曲的磷酸钙，金属和复合磷酸钙/金属涂层疲劳强度的方法

This part of ABNT NBR 15664 establishes a procedure for determining the shear and bending fatigue performance of calcium phosphate coatings, porous and nonporous metallic coatings and for determining the bending fatigue performance of metallic coating oversprayed with calcium phosphate.

ABNT NBR 15664-4-2009骨科植入物 - 产品涂层第4部分-拉伸强度测试确定的磷酸钙和金属涂层的方法

This part of ABNT NBR 15664 establishes a procedure for determining the tension properties of calcium phosphate, except those of hydroxyapatite, and metallic porous coatings adhering to dense metal substrate at ambient temperature, assessing the degree of adhesion of coatings to substrate or the internal cohesion of a coating in tension normal to the surface plane.