1.1 本指南涵盖了临床前的一般指南 体内 评估旨在修复或再生椎体间和/或后外侧脊柱环境中的骨的组织工程医疗产品（TEMP）。本指南中包含的TEMP可由但不限于天然或合成生物材料或其复合物组成，并可包含细胞或生物活性剂，如生长因子、合成肽、质粒或cDNA。本文中描述的模型代表了对材料在脊柱环境中诱导和/或增强骨生长能力的严格测试。 1.2 虽然临床TEMP可以与硬件结合用于初始稳定或其他目的，但本指南的重点是所选动物模型的适当性和TEMP的评估- 诱导修复，因此不关注组件或构造的问题。 1.3 指南包括对各种动物模型的描述和基本原理 体内 温度评估。动物模型利用了一系列物种，包括大鼠（鼠）、兔子（兔）、狗（犬）、山羊（山羊）、猪（猪）、绵羊（绵羊）和非人灵长类（灵长类）。结果指标包括 体内 基于射线照相、组织学和CT成像以及后续检查的评估 体外 修复评估，包括组织学分析和力学测试。对所有方法进行了简要描述和参考。用户应参考具体的测试方法以了解更多详细信息。 1.4 本指南不包括原材料测试、生物材料制备、灭菌或产品包装。 这些步骤的ASTM标准见参考文件（第节 2. ). 1.5 使用本指南中包含的任何方法可能不会产生与一个或多个特定应用中的临床表现一致的结果。 1.6 其他临床前方法也可能适用，本指南并不排除此类方法。材料必须适合其预期用途。在这方面需要额外的生物测试。 1.7 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。 1.8 以英寸-磅为单位的数值应视为标准值。括号中给出的值是到国际单位制的数学转换，仅供参考，不被视为标准值。 1.9 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 本指南旨在提供一系列 体内 有助于临床前研究和开发组织工程医疗产品（TEMP）的模型，用于临床修复或再生脊椎骨。 4.2 本指南包括对动物模型、手术注意事项、组织处理以及组织标本的定性和定量分析的描述。 4.3 鼓励用户在评估材料之前，利用适当的ASTM和其他指南对材料、TEMP或两者进行细胞毒性和生物相容性测试 体内 本文描述的模型。 4.4 建议安全测试应符合FDA《美国联邦法规》第21卷第58节的规定。 4.5 支持监管提交的安全性和有效性研究（例如，美国的研究设备豁免（IDE）、上市前批准（PMA）、510K、研究新药（IND）或生物制品许可证申请（BLA）提交）应符合监管机构关于医疗器械、生物制品或药物开发的适当指南。 4.6 动物模型结果不一定能预测人类结果，因此，应谨慎解释其对人类条件的潜在适用性。

1.1 This guide covers general guidelines for the pre-clinical in vivo assessment of tissue-engineered medical products (TEMPs) intended to repair or regenerate bone in an interbody and/or posterolateral spinal environment. TEMPs included in this guide may be composed of, but are not limited to, natural or synthetic biomaterials or composites thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. The models described in this document represent a stringent test of a material’s ability to induce and/or augment bone growth in the spinal environment. 1.2 While clinically TEMPs may be combined with hardware for initial stabilization or other purposes, the focus of this guide is on the appropriateness of the animal model chosen and evaluation of the TEMP-induced repair and as such does not focus on issues of components or constructs. 1.3 Guidelines include a description and rationale of various animal models for the in vivo assessment of the TEMP. The animal models utilize a range of species including rat (murine), rabbit (lapine), dog (canine), goat (caprine), pig (porcine), sheep (ovine), and non-human primate (primates). Outcome measures include in vivo assessments based on radiographic, histologic, and CT imaging as well as subsequent in vitro assessments of the repair, including histologic analyses and mechanical testing. All methods are described briefly and referenced. The user should refer to specific test methods for additional detail. 1.4 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of the product. ASTM standards for these steps are available in Referenced Documents (Section 2 ). 1.5 The use of any of the methods included in this guide may not produce a result that is consistent with clinical performance in one or more specific applications. 1.6 Other pre-clinical methods may also be appropriate, and this guide is not meant to exclude such methods. The material must be suitable for its intended purpose. Additional biological testing in this regard would be required. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.8 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.9 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 is aimed at providing a range of in vivo models to aid in pre-clinical research and development of tissue-engineered medical products (TEMPs) intended for the clinical repair or regeneration of bone in the spine. 4.2 This guide includes a description of the animal models, surgical considerations, and tissue processing as well as the qualitative and quantitative analysis of tissue specimens. 4.3 The user is encouraged to utilize appropriate ASTM and other guidelines to conduct cytotoxicity and biocompatibility tests on materials, TEMPs, or both, prior to assessment of the in vivo models described herein. 4.4 It is recommended that safety testing be in accordance with the provisions of the FDA Good Laboratory Practices Regulations 21 CFR 58. 4.5 Safety and effectiveness studies to support regulatory submissions (for example, Investigational Device Exemption (IDE), Premarket Approval (PMA), 510K, Investigational New Drug (IND), or Biologics License Application (BLA) submissions in the U.S.) should conform to appropriate guidelines of the regulatory bodies for development of medical devices, biologics, or drugs. 4.6 Animal model outcomes are not necessarily predictive of human results and should, therefore, be interpreted cautiously with respect to potential applicability to human conditions.