1.1 根据最终用途，本规程推荐了材料和设备的通用生物测试方法。虽然大多数植入材料都需要对可提取添加剂和残留单体或加工助剂残留物进行化学测试，但此类测试不包括在本实践中。读者需要注意的是，材料生物相容性测试领域是一个快速发展的领域，改进的方法也在快速发展，因此本实践必然只是一个指南。对当前技术和研究的透彻了解对于全面评估新材料至关重要。 1.2 这些测试协议旨在适用于人类应用的材料和医疗设备。还讨论了材料和设备的生物学评价，以及热原测试、批量生产测试等相关主题。测试包括对材料、最终产品和提取物进行的测试。 所有描述的测试程序都包含了关于当前技术状态的基本原理和评论。 1.3 用于人类使用的单组分或多组分医疗器械的材料的生物相容性在很大程度上取决于最终用途的特殊性质。对材料在一个设备应用中的成功有害的生物反应可能对材料在不同应用中的成功使用影响很小或没有影响。因此，不可能指定一套必要且足以确定所有材料和应用的生物相容性的生物相容性测试方法。 1.4 在某些情况下，组织工程医疗产品（TEMP）的评估可能涉及非组织材料和设备建议之外的不同或额外测试。在适当的情况下，这些差异将在本规程和所描述的附加测试中进行讨论。 1.5 研究动物的道德使用使个体研究者有义务确定在不过度使用动物的情况下进行必要测试的最有效方法。如果存在足够的先前数据来证实某些类型的安全信息，则这些指南不应被解释为意味着不必要地重复测试。 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和健康实践，并确定监管限制的适用性。 ====意义和用途====== 4.1 本规程的目的是推荐适当的生物终点评估（可能需要也可能不需要测试），以建立关于材料或装置的生物反应的合理置信水平，同时避免不必要的测试。 4.2 本规程旨在为材料研究者选择新材料或改性材料筛选的适当程序提供指导。由于每种材料和每种植入物情况都涉及其自身的独特情况，因此应根据需要修改这些建议，而不是构成材料所需的唯一评估。这些准则也不应被解释为任何特定情况的最低要求。虽然已经尝试为不同的植入环境提供建议，但对于特定材料或应用，一些建议的评估可能不必要或不合理。

1.1 This practice recommends generic biological test methods for materials and devices according to end-use applications. While chemical testing for extractable additives and residual monomers or residues from processing aids is necessary for most implant materials, such testing is not included as part of this practice. The reader is cautioned that the area of materials biocompatibility testing is a rapidly evolving field, and improved methods are evolving rapidly, so this practice is by necessity only a guideline. A thorough knowledge of current techniques and research is critical to a complete evaluation of new materials. 1.2 These test protocols are intended to apply to materials and medical devices for human application. Biological evaluation of materials and devices, and related subjects such as pyrogen testing, batch testing of production lots, and so on, are also discussed. Tests include those performed on materials, end products, and extracts. Rationale and comments on current state of the art are included for all test procedures described. 1.3 The biocompatibility of materials used in single or multicomponent medical devices for human use depends to a large degree on the particular nature of the end-use application. Biological reactions that are detrimental to the success of a material in one device application may have little or no bearing on the successful use of the material for a different application. It is, therefore, not possible to specify a set of biocompatibility test methods which will be necessary and sufficient to establish biocompatibility for all materials and applications. 1.4 The evaluation of tissue engineered medical products (TEMPs) may, in some cases, involve different or additional testing beyond those suggested for non-tissue-based materials and devices. Where appropriate, these differences are discussed in this practice and additional tests described. 1.5 The ethical use of research animals places the obligation on the individual investigator to determine the most efficient methods for performing the necessary testing without undue use of animals. Where adequate prior data exists to substantiate certain types of safety information, these guidelines should not be interpreted to mean that testing should be unnecessarily repeated. 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 and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== 4.1 The objective of this practice is to recommend appropriate biological endpoint assessments (which may or may not require testing) to establish a reasonable level of confidence concerning the biological response to a material or device, while at the same time avoiding unnecessary testing. 4.2 This practice is intended to provide guidance to the materials investigator in selecting the proper procedures to be carried out for the screening of new or modified materials. Because each material and each implant situation involves its own unique circumstances, these recommendations should be modified as necessary and do not constitute the only assessment that will be required for a material. Nor should these guidelines be interpreted as minimum requirements for any particular situation. While an attempt has been made to provide recommendation for different implant circumstances, some of the recommended assessment may not be necessary or reasonable for a specific material or application.