1.1 本规范涵盖了玻璃和玻璃陶瓷生物材料的材料要求和表征技术，这些材料拟用作大块多孔或粉末外科植入物，或用作外科设备的涂层，但不包括药物输送系统。 1.2 骨和软组织中的玻璃和玻璃陶瓷生物材料的生物反应已在临床应用中得到证实( 1- 12 ) 2. 和实验室研究( 13- 17 ). 1.3 本规范不包括合成羟基磷灰石、羟基磷灰石涂层、氧化铝陶瓷、α-和β-磷酸三钙以及白云石。 1.4 警告- 环保局和许多国家机构已将汞指定为一种有害物质，可导致中枢神经系统、肾脏和肝脏损害。汞或其蒸汽可能对健康有害，并对材料具有腐蚀性。处理汞和含汞产品时应小心。有关详细信息，请参阅适用的产品材料安全数据表（MSDS）和EPA网站(http://www.epa.gov/mercury/faq.htm)了解更多信息。用户应意识到，州法律可能禁止在您所在州销售汞或含汞产品，或同时销售两者。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。

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. 1.4 Warning— 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 EPA’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. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.