1.1 本规范涵盖了用于外科植入物的无机异种骨或同种异体骨（磷灰石）的材料要求。对于被称为无组织骨或无组织骨的材料，其必须符合本规范（参见 附录X1 ). 1.2 软组织和骨中磷灰石的生物反应具有临床使用历史和实验室研究的特点 ( 1. , 2. , 3. ) . 2. 存在有机成分的异种骨已被证明在人体宿主中具有抗原性 ( 4. ) 然而，在人类临床使用中，已证明完全脱组织的相同材料不会引起炎症或异物反应 ( 5. , 6. , 7. ) . 1.3 本规范特别不包括合成羟基磷灰石、羟基磷灰石涂层、陶瓷玻璃、三元磷酸钙、白云石和α- 和β-磷酸三钙。 1.4 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。 1.5 警告- 许多监管机构已将汞指定为一种危险物质，可导致严重的医疗问题。汞或其蒸汽已被证明对健康有害，并对材料具有腐蚀性。处理汞和含汞产品时要小心。有关更多信息，请参阅适用的产品安全数据表（SDS）。当地或国家法律禁止销售汞或含汞产品，或两者兼有。用户必须确定其所在地销售的合法性。 1.6 本标准并非旨在解决与其使用相关的所有安全问题（如有）。 本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 （参见 附录X2 ) . 1.7 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 material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1 ). 1.2 The biological response to apatite in soft tissue and bone has been characterized by a history of clinical use and by laboratory studies ( 1 , 2 , 3 ) . 2 Xenogeneic bone, with organic components present, has been shown to be antigenic in the human host ( 4 ) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use ( 5 , 6 , 7 ) . 1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 Warning— Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Use caution when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (SDS) for additional information. The potential exists that selling mercury or mercury-containing products, or both, is prohibited by local or national law. Users must determine legality of sales in their location. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. (See Appendix X2 ) . 1.7 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.