植入玻璃和玻璃陶瓷生物材料检测

YY/T 0964-2014外科植入物 生物玻璃和玻璃陶瓷材料

本标准规定了外科植入物用生物玻璃和玻璃陶瓷的材料要求和测试技术,本标准所述材料可用于多孔状和粉末状外科植入物,也可用于外科器械的涂层,但不包括药物输送系统。生物玻璃和玻璃陶瓷与骨和软组织的生物学反应已经在临床应用和实验室研究中得到验证。本标准不包含合成羟基磷灰石、羟基磷灰石涂层,氧化铝陶瓷,α-磷酸三钙和β-磷酸三钙以及白磷钙石。

ASTM F1538-1994植入用玻璃和玻璃陶瓷生物材料标准规范

1.1 This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems. 1.2 The biological response to glass and glass-ceramic biomaterials in bone and soft tissue has been demonstrated in clinical use (1-9) and laboratory studies (10-14).

ASTM F1538-2003植入用玻璃和玻璃陶瓷生物材料标准规范

1.1 This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems.1.2 The biological response to glass and glass-ceramic biomaterials in bone and soft tissue has been demonstrated in clinical use (1-12)2 and laboratory studies (13-17).1.3 This specification excludes synthetic hydroxylapatite, hydroxylapatite coatings, aluminum oxide ceramics, alpha- and beta-tricalcium phosphate, and whitlockite.

ASTM F1538-2003e1用于植入的玻璃和玻璃陶瓷生物材料的标准规范

1.1 This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems. 1.2 The biological response to glass and glass-ceramic biomaterials in bone and soft tissue has been demonstrated in clinical use (1-12) and laboratory studies (13-17). 1.3 This specification excludes synthetic hydroxylapatite, hydroxylapatite coatings, aluminum oxide ceramics, alpha- and beta-tricalcium phosphate, and whitlockite. 1.4 Warningx2014;Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPAx2019;s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.