Guidoin R, Rolland C, Fleury D, Charara J, Marceau D, Bronskill M, Cardou A, King M, Lessard R
Department of Surgery, Laval University, Québec, Canada.
ASAIO J. 1994 Oct-Dec;40(4):943-58.
Physical characterization of unimplanted gel filled mammary prostheses was undertaken using both destructive and non-destructive test methods. Physical properties measured included mass, volume, optical transmittance, coefficient of kinetic friction, mechanical stiffness, dynamic response to a stationary random vibration, bursting strength, elasticity of the envelopes, and nuclear magnetic resonance relaxation times. The data obtained from this study will provide reference points for quantifying the rate of degradation of prostheses in past and current clinical use. Some of the test methods are suitable for use as routine quality control procedures to improve the uniformity of the properties and performance of breast prostheses. This investigation also showed that some currently used prostheses do not comply with the relevant American Society for Testing and Materials standards, or even with the manufacturers' own stated claims or specifications.
使用破坏性和非破坏性测试方法对未植入的凝胶填充乳房假体进行了物理特性分析。所测量的物理特性包括质量、体积、透光率、动摩擦系数、机械刚度、对固定随机振动的动态响应、破裂强度、包膜弹性以及核磁共振弛豫时间。从这项研究中获得的数据将为量化过去和当前临床使用中假体的降解速率提供参考点。其中一些测试方法适合用作常规质量控制程序，以提高乳房假体的特性和性能的均匀性。这项调查还表明，一些目前使用的假体不符合美国材料与试验协会的相关标准，甚至不符合制造商自己宣称的要求或规格。
