1.1 本指南涵盖了适用于生物医学或制药应用或两者的壳聚糖盐的评估，包括但不限于组织工程医疗产品（TEMP）。 1.2 本指南介绍了与壳聚糖盐的功能性、表征和纯度相关的关键参数。 1.3 与任何材料一样，壳聚糖的某些特性可能会因生产特定零件或装置所需的加工技术（如成型、挤压、机加工、组装、灭菌等）而改变。 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。 1.4 警告- 环保局和许多国家机构已将汞指定为一种有害物质，可导致中枢神经系统、肾脏和肝脏损害。汞或其蒸汽可能对健康有害，并对材料具有腐蚀性。处理汞和含汞产品时应小心。有关详细信息，请参阅适用的产品材料安全数据表（MSDS）和美国环保局网站（http: //www.epa。gov/mercury/faq。htm）以获取更多信息。用户应意识到，州法律可能禁止在您所在州销售汞或含汞产品，或同时销售两者。 1.5 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。 1.6 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、健康和环境实践，并确定监管限制的适用性。 1.7 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 本指南列出了与壳聚糖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壳聚糖或壳聚糖盐。 本标准旨在为正确表征、评估和确保特定壳聚糖性能的一致性所需的测试方法和类型提供指导。它可能用于有关当局对含有壳聚糖的装置进行监管。 4.2 根据支持性生物相容性和物理测试数据，本指南所涵盖的壳聚糖盐可以凝胶化、挤压或以其他方式配制成生物医学设备，用作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。 4.3 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。这些包括壳聚糖的鉴定、物理和化学表征和测试、杂质分布和性能相关测试。

1.1 This guide covers the evaluation of chitosan salts 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 for the functionality, characterization, and purity of chitosan salts. 1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy. 1.4 Warning— Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 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 contains a listing of those characterization parameters that are directly related to the functionality of chitosan. This guide can be used as an aid in the selection and characterization of the appropriate chitosan or chitosan salt for a particular application. This standard 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 chitosan. It may have use in the regulation of devices containing chitosan by appropriate authorities. 4.2 The chitosan salts covered by this guide may be gelled, extruded, or otherwise formulated into biomedical devices for use as 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. 4.3 To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These include identity of chitosan, physical and chemical characterization and testing, impurities profile, and performance-related tests.