骨水泥性能的试验评定  

EXPERIMENTAL ASSESSMENT OF BONE CEMENTS PERFORMANCE

作　　者：王祚龑[1] 宋铎[1] 

机构地区：[1]天津市医疗器械质量监督检验中心,天津300191

出　　处：《理化检验（物理分册）》2007年第6期293-295,共3页Physical Testing and Chemical Analysis(Part A:Physical Testing)

摘　　要：依据ISO 5833∶2002《外科植入物——丙烯酸类树脂骨水泥》[1],测定了6种品牌(国产和进口)骨水泥的全部性能。结果表明,4种品牌骨水泥达到标准要求,两种品牌骨水泥未达到标准要求。所有受试骨水泥的外观、液体组分稳定性、平均最高温度、平均挤入度以及固化后的平均抗压强度、平均弯曲模量及平均抗弯强度均符合标准要求。C种品牌的液体组分精度和粉体组分精度不符合标准要求。B种品牌骨水泥的平均面团时间和平均凝固时间不符合标准要求。All performance index of six kinds of brands for domestic and import bone cement have been determined according to ISO 5833 - 2002 《Implants for surgery Acrylic resin cements》. The result indicated that four kinds of brands bones cement achieved the standard request, two kinds of brands bones cement has not met the standard requirements. All the performance of the bone cement, such as the appearance, the liquid component stability , the average maximum temperature , the intrusion of the liquid powder mixture as well as the solidification average compressive strength, the average bending modulus, the average bending strength achieved the international standard request. C kind of brand bone cement the accuracy of liquid component contents and the accuracy of powder component contents have not achieved the standing operating procedure. B kind of brand bone cement average roughing time and the average setting time have not achieved the standing operating procedure.

关 键 词：骨水泥 ISO5833 评定 

分 类 号：R318.17[医药卫生—生物医学工程]