1.1 本含胶原蛋白生物材料表征指南旨在提供特征、性质和测试方法，供生产商、制造商和研究人员使用，以更清楚地识别所使用的特定胶原蛋白材料。有20多种胶原蛋白和每种胶原蛋白的不同性质，一份文件会很麻烦。本指南将重点介绍I型胶原蛋白的表征，这是哺乳动物中最丰富的胶原蛋白，尤其是在皮肤和骨骼中。从这些来源分离的胶原可包含其它类型的胶原，例如III型和V型。本指南不提供任何胶原蛋白产品或产品混合物的具体参数，也不提供这些产品预期用途的可接受性。胶原可以来自任何来源，包括但不限于动物或尸体来源、人细胞培养物或重组来源。胶原蛋白的生物学、免疫学或毒理学性质可以根据源材料而变化。必须彻底研究从上述来源中的每一种制备的胶原蛋白的性质，因为作为源材料的函数的胶原蛋白性质的变化没有被彻底理解。本指南旨在重点介绍纯化的I型胶原作为外科植入物的起始材料和组织工程医疗产品（TEMPs）的基质；一些方法可能不适用于明胶或组织植入物。该指南可用作表征其他类型胶原的模板。 1.2 对软组织中胶原蛋白的生物学反应已被临床使用历史充分证明 ( 1 , 2 ) 2 和实验室研究 ( 3- 6 ) 生物相容性和特定应用的适用性由产品制造商负责。指导用户使用ISO 10993系列评估医疗器械的生物风险。 1.3 许多I型胶原来自动物来源，其制造商应解决病毒和传染性海绵状脑病(TSE)试剂的风险。本指南向读者介绍了应该查阅的权威文件。 1.4 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。 1.5 以下注意事项仅适用于第节 5 本指南中讨论了表征方法: 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。 1.6 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 本指南的目的是为I型胶原作为外科植入物的起始材料和组织工程医疗产品（TEMPs）的基质的表征提供指导。本指南列出了与胶原蛋白功能直接相关的物理和化学参数。该指南可用于帮助选择和表征用于特定用途的适当胶原起始材料。并非所有测试或参数都适用于胶原蛋白的所有用途，用户应选择并证明用于表征目的的测试子集。 4.2 本指南涵盖的胶原蛋白可用于广泛的应用、形式或医疗产品，例如(但不限于)医疗装置、组织工程医疗产品(TEMP)或用于植入的细胞、药物或DNA递送装置。胶原蛋白在实际应用中的使用应基于生物相容性和物理测试数据等因素。本指南中的建议不应被解释为任何组织工程医疗产品或给药应用的临床成功的保证。4.3 在确定所提供的胶原蛋白是否满足上述医学和研究应用的要求时，应考虑以下一般领域:胶原蛋白来源、杂质概况以及化学、生物和物理表征和测试。 4.4 由于本指南旨在用于医疗产品，因此在确定所提供的胶原蛋白是否满足临时工产品的使用要求时，应考虑来自适当监管机构的许多与临时工产品的生产、监管和监管批准相关的指导文件。虽然本指南中引用了一些相关文件，但更多文件适用于器械、生物制剂、药物和组合产品。

1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and the different properties of each, a single document would be cumbersome. This guide will focus on the characterization of Type I collagen, which is the most abundant collagen in mammals, especially in skin and bone. Collagen isolated from these sources may contain other types of collagen, for example, Type III and Type V. This guide does not provide specific parameters for any collagen product or mix of products or the acceptability of those products for the intended use. The collagen may be from any source including, but not limited to, animal or cadaveric sources, human cell culture, or recombinant sources. The biological, immunological, or toxicological properties of the collagen may vary, depending on the source material. The properties of the collagen prepared from each of the above sources must be thoroughly investigated, as the changes in the collagen properties as a function of source materials is not thoroughly understood. This guide is intended to focus on purified Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs); some methods may not be applicable for gelatin or tissue implants. This guide may serve as a template for characterization of other types of collagen. 1.2 The biological response to collagen in soft tissue has been well documented by a history of clinical use ( 1 , 2 ) 2 and laboratory studies ( 3- 6 ) . Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product manufacturer. Users are directed to the ISO 10993 series for evaluating biological risks of medical devices. 1.3 Many Type I collagens are derived from animal sources, and their manufacturers should address the risk of viruses and transmissible spongiform encephalopathy (TSE) agents. This guide refers readers to authoritative documents which should be consulted. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 The following precautionary caveat pertains only to Section 5 , of this guide, which discusses characterization approaches: 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. 1.6 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 The objective of this guide is to provide guidance in the characterization of Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs). This guide contains a listing of physical and chemical parameters that are directly related to the functions of collagen. This guide can be used as an aid in the selection and characterization of the appropriate collagen starting material for the specific use. Not all tests or parameters are applicable to all uses of collagen and users are expected to select and justify a subset of the tests for characterization purposes. 4.2 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) medical devices, tissue engineered medical products (TEMPs) or cell, drug, or DNA delivery devices for implantation. The use of collagen in a practical application should be based, among other factors, on 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 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in the above mentioned medical and research applications: source of collagen, impurities profile, and chemical, biological, and physical characterization and testing. 4.4 As this guide is intended for medical products, there are many relevant guidance documents from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of TEMPs products which should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs. While some relevant documents are referenced in this guide, many more are applicable to devices, biologics, drugs, and combination products.