1.1 历史上，Scott Boden博士等（埃默里脊柱矫形中心）开发并报告了单层兔后外侧或横突间腰椎融合模型，该模型被提议为非临床模型，可用于复制后外侧脊柱自体髂骨移植的临床相关融合率 ( 1. , 2. ) . 2. 该模型通常用于向监管机构提交报告，以评估与其他材料或自体髂骨移植相比，骨空隙填充材料对脊柱后外侧融合的潜在疗效。 将本标准的建议作为监管提交文件的一部分使用并不保证监管许可，应视为监管提交文件数据的一部分。 1.2 本指南涵盖了评估产品在腰椎横突间脊柱融合模型中引起和/或促进骨形成的有效性的一般指南 体内 . 本指南适用于可能由以下一个或多个组件组成的产品: 天然生物材料（如脱矿骨）和合成生物材料（如硫酸钙、甘油和反相聚合物），作为添加剂、填料和/或赋形剂（辐射防护剂、防腐剂和/或处理剂）。不应假设使用本指南进行良好评估的产品在用于临床环境时会形成骨骼。本指南的主要目的是促进骨空隙填充物和/或自体移植延长剂产品的公平比较 体内 . 本指南的目的不是排除其他既定方法。 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 本标准并非旨在解决与使用骨空隙填充物相关的所有安全问题（如有）。本标准的用户有责任根据适用的监管指导文件，在所述产品的开发过程中建立适当的安全和健康实践，并在实施本指南以评估骨密度时建立适当的安全和健康实践- 形成/提升产品的能力。 1.5 本标准无意解决21 CFR第58部分中关于良好实验室实践或国际标准对应物OECD良好实验室实践原则（GLP）的要求。研究赞助者有责任了解动物研究的要求，即数据可用于支持上市前应用，包括对人员、方案内容、记录保留和畜牧业的要求。 1.6 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。 ====意义和用途====== 4.1 本指南涵盖了动物植入方法和骨空隙填充物的分析，以确定材料或物质是否导致腰椎横突间脊柱融合，其定义是其导致骨形成的能力 体内 .

1.1 Historically, the single-level rabbit posterolateral, or intertransverse, lumbar spine fusion model was developed and reported on by Dr. Scott Boden, et. al. (Emory Spine Center for Orthopedics) and the model has been proposed as a non-clinical model which may be used to replicate clinically-relevant fusion rates for iliac crest autograft in the posterolateral spine ( 1 , 2 ) . 2 This model is used routinely in submissions to regulatory bodies for the purpose of evaluating the potential efficacy of bone void filler materials as compared to other materials or iliac crest autograft to effect spinal posterolateral fusion. The use of this standard’s recommendations as part of a regulatory submission does not provide any guarantee of regulatory clearance and should be considered as a part of the data provided for regulatory submission. 1.2 This guide covers general guidelines to evaluate the effectiveness of products intended to cause and/or promote bone formation in the lumbar intertransverse process spinal fusion model in vivo . This guide is applicable to products that may be composed of one or more of the following components: natural biomaterials (such as demineralized bone), and synthetic biomaterials (such as calcium sulfate, glycerol, and reverse phase polymeric compounds) that act as additives, fillers, and/or excipients (radioprotective agents, preservatives, and/or handling agents). It should not be assumed that products evaluated favorably using this guidance will form bone when used in a clinical setting. The primary purpose of this guide is to facilitate the equitable comparison of bone void fillers and/or autograft extender products in vivo . The purpose of this guide is not to exclude other established methods. 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 standard does not purport to address all of the safety concerns, if any, associated with the use of bone void fillers. It is the responsibility of the user of this standard to establish appropriate safety and health practices involved in the development of said products in accordance with applicable regulatory guidance documents and in implementing this guide to evaluate the bone-forming/promoting capabilities of the product. 1.5 This standard does not purport to address the requirements under 21 CFR Part 58 concerning Good Laboratory Practices or international standard counterpart OECD Principles of Good Laboratory Practice (GLP). It is the responsibility of the sponsor of the study to understand the requirements for conduct of animal studies whereby the data may be used to support premarket applications, including requirements for personnel, protocol content, record retention and animal husbandry. 1.6 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. ====== Significance And Use ====== 4.1 This guide covers animal implantation methods and analysis of bone void fillers to determine whether a material or substance leads to lumbar intertransverse process spinal fusion, as defined by its ability to cause bone to form in vivo .