1.1 本指南描述了可植入合成聚合物可吸收器械的化学、物理、机械、生物相容性和临床前评估的一般指南。本指南还描述了评估可吸收植入物或植入物组件时可能有用且应考虑的评估方法。 1.2 所描述的评估可以帮助制造商确定可吸收植入装置的安全性和有效性。然而，这些面向聚合物材料的指南不一定反映任何特定植入物应用（例如，骨科、心血管、缝合线和真皮填充物）的总需求，这可能需要额外的和潜在必要的特定应用评估。 1.3 本指南旨在涵盖所有形式的可吸收聚合物组件和装置，包括固体（例如，注射-模制)和多孔(例如纤维)形式。本指南还旨在涵盖由无定形和/或半结晶可吸收聚合物系统制造的装置。 1.4 本指南的主要重点是评估由降解的合成聚合物制成的器械 体内 主要通过水解(例如α-羟基-聚酯)。本文建议的评价方法可以适用于或不适用于由在植入时通过其他机制(例如，酶诱导的降解)基本上降解的材料形成的植入物。 1.5 本指南参考并总体描述了评估可吸收材料、部件和装置的各种方法。用户需要参考具体的测试方法以了解更多细节。此外，一些推荐的测试方法可能需要修改以解决特定设备、结构或应用的特性。1.6 遵守这些指南的所有方面不是强制性的，因为本指南中列出的评估和测试不一定与所有可吸收植入物系统和应用相关。 1.7 用作基质以控制 体内 可以根据本文所述的许多方法评估生物活性剂(药物、抗微生物剂等)的释放。然而，可能需要本指南未涵盖的其他测试方法来评估生物活性剂的组成、负载、释放动力学、安全性和有效性，以及其与临床使用期间可吸收聚合物释放的降解物的相互作用。 1.8 可吸收聚合物与陶瓷和/或金属的复合材料可根据本文所述的许多方法进行评价。然而，可能需要本指南未涵盖的其他测试方法来评估复合材料的其他成分。 1.9 以SI单位表示的值将被视为标准值。本标准不包括其他计量单位。 1.10 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 1.11 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》中确立的国际公认的标准化原则制定的。======意义和用途====== 4.1 本指南旨在为评估和评价提供指导，以帮助各种可吸收组件和器械的临床前研究和开发。 4.2 本指南包括各种预期用途、加工条件、评估以及从原材料到成品成分的定性和定量分析的简要描述。 4.3 鼓励用户利用适当的ASTM和其他标准对可吸收材料、器械组件或器械进行物理、化学、机械、生物相容性和临床前试验，然后在 体内 模特。 4.4 每当可吸收材料与其它物质(生物活性、聚合物或其它物质)混合或涂覆时，所得复合材料的物理和降解性能可能与基础聚合物显著不同。因此，除非先前的经验可以证明其他理由，否则本文所述的性能表征应在复合结构上而不是在单个部件上进行。 4.5 在可行的情况下，应根据FDA药物非临床研究质量管理规范法规21 CFR 58的规定进行可吸收材料的评估。 4.6 支持临床或商业用途或两者的监管批准的研究应符合适当的国家采用的指令或指南，或两者，用于医疗器械的开发（例如，CE批准；美国-FDA研究器械豁免（IDE）、上市前批准（PMA）或510K提交）。 4.7 基于物理、化学、机械、生物相容性和临床前测试模型数据的评估非常有价值，但具有固有的局限性。因此，需要仔细考虑每项评估的临床相关性，并提醒用户临床前评估可能无法预测人类临床表现。

1.1 This guide describes general guidelines for the chemical, physical, mechanical, biocompatibility, and preclinical assessments of implantable synthetic polymeric absorbable devices. This guide also describes evaluation methods that are potentially useful and should be considered when assessing absorbable implants or implant components. 1.2 The described evaluations may assist a manufacturer in establishing the safety and effectiveness of an absorbable implant device. However, these polymeric material-oriented guidelines do not necessarily reflect the total needs for any particular implant application (for example, orthopedic, cardiovascular, sutures, and dermal fillers), which may require additional and potentially essential application-specific evaluations. 1.3 This guide is intended to cover all forms of absorbable polymeric components and devices, including solid (for example, injection-molded) and porous (for example, fibrous) forms. This guide is also intended to cover devices fabricated from amorphous and/or semicrystalline absorbable polymer systems. 1.4 This guide has been generated with principal emphasis on the evaluation of devices formed from synthetic polymers that degrade in vivo primarily through hydrolysis (for example, α-hydroxy-polyesters). Evaluation methods suggested herein may or may not be applicable to implants formed from materials that, upon implantation, are substantially degraded through other mechanisms (for example, enzymatically induced degradation). 1.5 This guide references and generally describes various means to assess absorbable materials, components, and devices. The user needs to refer to specific test methods for additional details. Additionally, some of the recommended test methods may require modification to address the properties of a particular device, construct, or application. 1.6 Adherence to all aspects of these guidelines is not mandatory, in that assessments and tests listed within this guide are not necessarily relevant for all absorbable implant systems and applications. 1.7 Absorbable polymers used as a matrix to control the in vivo release of bioactive agents (drugs, antimicrobials, and so forth) may be evaluated according to many of the methods described herein. However, additional test methods not covered by this guide will likely be needed to evaluate a bioactive agent’s composition, loading, release kinetics, safety, and efficacy, as well as its interaction with the degradants released from the absorbable polymers during the clinical use. 1.8 Composites of absorbable polymers with ceramics and/or metals may be evaluated according to many of the methods described herein. However, additional test methods not covered by this guide will likely be needed to evaluate the composite’s other component(s). 1.9 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.10 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. 1.11 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 guidance for assessments and evaluations to aid in preclinical research and development of various absorbable components and devices. 4.2 This guide includes brief descriptions of various intended uses, processing conditions, assessments, and both qualitative and quantitative analyses for raw materials to finished product components. 4.3 The user is encouraged to utilize appropriate ASTM and other standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on absorbable materials, device components, or devices prior to assessment in an in vivo model. 4.4 Whenever an absorbable material is mixed or coated with other substances (bioactive, polymeric, or otherwise), the physical and degradation properties of the resulting composite may differ significantly from the base polymer. Thus, unless prior experience can justify otherwise, performance characterizations described herein should be conducted on the composite construct rather than on individual components. 4.5 Assessments of absorbable materials should be performed in accordance with the provisions of the FDA Good Laboratories Practices Regulations 21 CFR 58, where feasible. 4.6 Studies to support regulatory approval for clinical or commercial use, or both, should conform to appropriate nationally adopted directives or guidelines, or both, for the development of medical devices (for example, CE approval; US-FDA Investigational Device Exemption (IDE), Pre-Market Approval (PMA), or 510K submission). 4.7 Assessments based upon data from physical, chemical, mechanical, biocompatibility, and preclinical testing models are highly valuable but carry inherent limitations. Thus, the clinical relevance of each assessment needs to be carefully considered and the user is cautioned that preclinical evaluations may not be predictive of human clinical performance.