外科植入物多孔涂层体视学结构性能测试研究

Research on the Stereological Structures of Porous Coating About Surgical Implants

多孔涂层结构体视学性能可以按照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》评价适用涂层的平均厚度、平均孔隙率、平均孔隙截距;个性化3D打印医疗器械产品也可参考该方法评价3D打印多孔结构的平均孔隙率和平均孔隙截距。但该方法不适用于陶瓷涂层,因为该涂层无法使用金相制备技术制备出准确的涂层横截面,所以对于植入物基体表面等离子喷涂羟基磷灰石涂层的样品无法开展多孔结构的测试与评价;同时,该方法不适用于表征厚度<300μm的涂层,对于植入物表面<300μm的涂层,无法开展孔隙率与孔隙截距的评价。在ISO 13179-1:2014《外科植入物金属外科植入物等离子喷涂纯钛涂层第1部分:通用要求》条款4.3要求对于平均厚度>300μm的涂层开展孔隙率与孔隙截距的评价。多孔涂层平均厚度500~1500μm,孔隙率在30%~70%,平均孔隙截距100~1000μm,该指标要求被行业内较多企业广泛参考使用。钛涂层表面喷涂HA的复合涂层可以按整体复合涂层进行多孔结构的测试与评价。

The stereoscopic performance of the porous coating structure can be evaluated in accordance with YY/T 0988.14-2016 Surgical Implant Coating Part 14 Stereoscopic Evaluation Method of Porous Coating,the average thickness,porosity and average pore intercept of the applicable coating.This method is not suitable for ceramic coatings,because this coating cannot use metallographic preparation techniques to produce accurate coating cross sections.Therefore,based on the clear definition of this clause,the test of the porous structure cannot be carried out for the samples of plasma sprayed hydroxyapatite coating on the surface of the implant substrate.This method is not suitable for the characterization of coatings with a thickness of less than 300μm.Therefore,based on the clear definition of this clause,the evaluation of porosity and pore intercept cannot be carried out for coatings with an implant surface of less than 300μm.In the 4.3 clause of ISO 13179-1:2014 Surgical Implants Metal Surgical Implants Plasma Sprayed Pure Titanium Coating Part 1:General Requirements,it is clearly proposed to carry out porosity and pore intercept for coatings with an average thickness greater than 300μm Evaluation.The average thickness of the porous coating is between 500-1500μm,the porosity is between 30%-70%,and the pore intercept is between 100-1000μm.This guide is widely used by many companies in the industry.The composite coating with HA sprayed on the surface of the titanium coating can only be tested and evaluated for the porous structure according to the overall composite coating.