Regulatory perspective on characterization and testing of orthopedic bone cements

被引:27
作者
Demian, HW [1 ]
McDermott, K [1 ]
机构
[1] US FDA, Ctr Devices & Radiol Hlth, Off Device Evaluat, Rockville, MD 20850 USA
关键词
PMMA; bone cement; pre-clinical test methods; US regulatory perspective;
D O I
10.1016/S0142-9612(97)00122-1
中图分类号
R318 [生物医学工程];
学科分类号
0831 ;
摘要
This paper provides a general regulatory background of acrylic bone cements, chemical composition information on several commercially available bone cements, physical and chemical methods of analyses, mechanical test methods, and risks and failure mechanisms of acrylic bone cements. Suggestions and recommendations presented in Tables 2 and 3 are not mandatory requirements but reflect data and methodologies which the FDA's Orthopedic Devices Branch (ORDB) believes to be acceptable to evaluate most pre-clinical data. FDA may require information in addition to that contained in this paper. In some instances, a sponsor may be able to sufficiently justify the omission of some tests. Although this paper describes certain administrative requirements, it does not take the place of the requirements contained in Title 21 of the Code of Federal Regulations (21 CFR) Parts 801, 807, 812, and 814 or those found in the statute. (C) 1998 Elsevier Science Ltd. All rights reserved.
引用
收藏
页码:1607 / 1618
页数:12
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