1.1 本规范涵盖了用于承重外科植入物应用的高纯度致密氧化铝的材料要求。 1.2 本规范不涵盖成品零件（例如，股骨头、髋臼植入物、牙科植入物等）。其目的是对交付给零件制造商的材料进行鉴定。 1.3 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.4 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 for high-purity, dense aluminum oxide for load-bearing surgical implant applications. 1.2 This specification does not cover finished parts (for example, femoral heads, acetabular inserts, dental implants and the like). It is intended as a qualification of the material as delivered to the parts manufacturer. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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.