1.1本指南涵盖了适用于生物医学或制药应用或两者的透明质酸的评估，包括但不限于组织工程医疗产品（TEMP）。 1.2本指南阐述了与透明质酸的特性和纯度相关的关键参数。 1.3与任何材料一样，透明质酸的某些特性可能会因生产特定配方或装置所需的加工技术而改变，如交联和灭菌。因此，应使用适当的测试方法来评估这种聚合物的制造形式的性能，以确保安全性和有效性，本指南中未提及。 1.4 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，并确定监管要求的适用性。 ====意义和用途====== 本指南列出了与透明质酸功能直接相关的表征参数。本指南可用于帮助选择和表征适合特定应用的透明质酸。本指南旨在为正确表征、评估和确保特定透明质酸性能的一致性所需的测试方法和类型提供指导。 它可能会被有关当局用于监管这些设备。 根据支持性生物相容性和物理测试数据，本指南所涵盖的透明质酸可以凝胶化、交联、挤出或以其他方式配制成生物医学设备，用于组织工程医疗产品或植入用药物递送设备。本指南中的建议不应被解释为任何组织工程医疗产品或药物递送应用中临床成功的保证。 为了确保所提供的材料满足TEMP中使用的要求，应考虑几个表征的一般领域。 这些是:透明质酸的特性、物理和化学特性和测试、杂质概况和性能相关测试。

1.1 This guide covers the evaluation of hyaluronan suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs). 1.2 This guide addresses key parameters relevant to the characterization and purity of hyaluronan. 1.3 As with any material, some characteristics of hyaluronan may be altered by processing techniques, such as cross-linking and sterilization, required for the production of a specific formulation or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy and are not addressed in this guide. 1.4 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 requirements prior to use. ====== Significance And Use ====== This guide contains a listing of those characterization parameters that are directly related to the functionality of hyaluronan. This guide can be used as an aid in the selection and characterization of the appropriate hyaluronan for a particular application. This guide is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular hyaluronan. It may have use in the regulation of these devices by appropriate authorities. The hyaluronan covered by this guide may be gelled, cross-linked, extruded, or otherwise formulated into biomedical devices for use in tissue engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application. To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These are: identity of hyaluronan, physical and chemical characterization and testing, impurities profile, and performance-related tests.