<span style="font-family:&quot;font-size:medium;">陶瓷人工髋关节产品的物理机械性能研究关注点探讨</span>

杨抒, 翟豹, 张家振, 丁金聚, 高进涛, 刘斌

doi:magtech-2025-07-01-00001

中国药物评价 >

2025 , Vol. 42 >Issue 5: 332 - 332-336

DOI: https://doi.org/magtech-2025-07-01-00001

监管科学与应用

陶瓷人工髋关节产品的物理机械性能研究关注点探讨

展开

1.国家药品监督管理局医疗器械技术审评检查大湾区分中心，广东深圳 518045；
2.国家药品监督管理局医疗器械技术审评中心，北京 100076

杨抒，男，博士，工程师，研究方向：骨科医疗器械的技术审评。

收稿日期: 2025-07-01

录用日期: 2025-11-27

网络出版日期: 2025-12-15

收起

Discussion of Key Attentions on Physical and Mechanical Properties of Ceramic Artificial Hip Joint Products

Expand

1.GBA Center for Medical Device Evaluation and Inspection， NMPA， Guangdong Shenzhen 518045， China；
2.Center for Medical Device Evaluation， Beijing 100076， China

Received date: 2025-07-01

Accepted date: 2025-11-27

Online published: 2025-12-15

Fold

摘要

陶瓷材料具有优异的生物相容性、稳定性和耐磨损性能，是制造人工髋关节关节面的理想材料。据统计，陶瓷对聚乙烯界面和陶瓷对陶瓷界面的人工髋关节假体有着广泛的临床应用，相较于传统金属合金，很多陶瓷材料的抗张抗弯强度更优，但抗碎裂性能有待提升，临床服役中存在破碎失效的风险，因此在审评过程中需对相关风险的把控予以重点关注。本研究通过检索陶瓷髋关节产品的相关信息，阐述了陶瓷人工髋关节产品在骨科领域的发展历程。同时，结合现行审评要求及审评经验探讨了相关产品在注册审评过程中的关注点，梳理了当前机械性能评价测试项目的要求，并基于学术研究的进展指出目前评价方法存在的局限性，以期为制造商评估陶瓷人工髋关节产品的安全、有效提供指导建议，为规范相关行业发展提供参考意见。

关键词： ; font-size:medium; ">陶瓷假体；体外评价；人工髋关节；医疗器械注册

本文引用格式

杨抒, 翟豹, 张家振, 丁金聚, 高进涛, 刘斌 . 陶瓷人工髋关节产品的物理机械性能研究关注点探讨[J]. 中国药物评价, 2025 , 42(5) : 332 -332-336 . DOI: magtech-2025-07-01-00001

Abstract

Ceramic materials， witch have excellent bio-compatibility， corrosion resistance， and wear resistance， are ideal for manufacturing bearing surfaces of artificial hip joints. According to statistics， ceramic-on-polyethylene and ceramic-on-ceramic artificial hip joint prostheses have been widely used in clinical applications. Compared to conventional metal alloys， many ceramic materials exhibit superior tensile/flexural strength， yet their fracture resistance requires improvement. As there is a risk of fracture failure in clinical applications， necessitating special attention to risk control during the regulatory evaluation process. This study compiles relevant information on ceramic hip joint products and outlines the developmental history of ceramic artificial hip joints in the field of orthopedics. Furthermore， it explores key considerations in the registration and evaluation process by referencing current regulatory requirements and review experiences. The study also summarizes existing mechanical performance evaluation and testing criteria while highlighting the limitations of current assessment methods based on advancements in academic research. The findings aim to serve as a reference for standardizing industry practices and promoting the healthy development of the field.

Key words： ; font-size:medium; ">Ceramic prosthesis； In-vitro evaluation； Hip Joint； Medical device Registration

参考文献

[1] 杨抒. 全髋关节假体滑动面磨损与组合面微动腐蚀研究[D]. 成都：西南交通大学， 2022.
     [2] 杨抒，崔文，张小刚，等. 国内全髋关节置换磨损测试及数值模拟研究进展 [J]. 摩擦学学报， 2021，41（6）：1004-1018.
     [3] 翁习生. 陶瓷全髋关节置换术—理论与临床实践 [M]. 北京：中国协和医科大学出版社， 2022：106-145.
     [4] 陶瓷人工关节厂家齐聚无锡加速实现关键核心原材料的自主供应 [Z]. 广东：CCME众智医材， 2025.
     [5] 人工关节集中带量采购协议期满接续采购文件 [R]. 天津：国家组织高值医用耗材联合采购办公室， 2024：4-14.
     [6] 翟豹. 陶瓷材料在人工髋关节假体中的应用 [N]. 中国医药报， 2020-03-10（1-2）.
     [7] Administration USFD. Guidance Document For The Preparation of Premarket Notification For Ceramic Ball Hip Systems [Z]. Dockets Management Food and Drug Administration 5630 Fishers Lane， Rm 1061 Rockville， MD 20852； U.S. Food & Drug Administration， 1995.
     [8] Perrichon A， Reynard B， Gremillard L， et al. A testing protocol combining shocks， hydrothermal ageing and friction， applied to Zirconia Toughened Alumina (ZTA) hip implants [J]. J Mechanical Behavior of Biomedical Materials， 2017， 65： 600-608.
     [9] Willams SR， Wu JJ， Unsworth A， et al. Wear and surface analysis of 38 mm ceramic-on-metal total hip replacements under standard and severe wear testing conditions [J]. Proceedings of the Institution of Mechanical Engineers， Part H： J Engineering Med， 2011， 225(8)： 783-796.
     [10] Mazen AH， MJL， Sabine B， et al. Wear of novel ceramic-on-ceramic bearings under adverse and clinically relevant hip simulator conditions [J]. J Biomedical Materials Research Part B， Applied Biomaterials， 2013， 101(8)： 1456-1462.
     [11] PSA， MBR. A simple surrogate test method to rank the wear performance of prospective ceramic materials under hip prosthesis edge-loading conditions [J]. J Biomedical Materials Research Part B， Applied Biomaterials， 2014， 102(2)： 311-321.
     [12] 廉超，张茂荣，王俊元，等. 陶瓷髋关节股骨头直径尺寸与动态微分离条件下边缘负载的关系 [J]. 中国组织工程研究， 2019， 23(32)： 5085-5091.

Options

文章导航

模态框（Modal）标题

摘要

本文引用格式

Abstract

参考文献