1.1 本指南涵盖了适用于生物医学或制药应用的猪纤维蛋白原的评估，包括但不限于组织工程医疗产品（TEMP）。 1.2 本指南介绍了与猪纤维蛋白原的功能、特性和纯度相关的关键参数。 1.3 与任何材料一样，猪纤维蛋白原的某些特性可能会因加工技术而改变，例如静电纺丝 ( 1. ) 2. 以及生产特定配方或设备所需的灭菌。因此，应使用适合于确保安全性和有效性的测试方法来评估这种蛋白质的制造形式的特性，本指南中未提及。 1.4 本文件的主要重点是从猪血中提取的纤维蛋白原，它类似于人类纤维蛋白原。与其他物种（如牛、绵羊、山羊、麋鹿和鹿）相比，猪的最大优势是它们传播传染性海绵状脑炎（TSE）的可能性较小（ISO 22442-1附录D；世界卫生组织指南，2003；世界卫生组织指南，2006；世界卫生组织指南，2010）。当有用的信息可用时，本文件也可能讨论其他来源的纤维蛋白原。部分章节还讨论了纤维蛋白。 1.5 单位- 以国际单位制表示的数值应视为标准。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====== 5.1 本指南旨在为猪纤维蛋白原作为外科植入物起始材料和组织工程医疗产品基质的特性表征提供指导。本指南包含一组与猪纤维蛋白原功能直接相关的物理和化学参数。本指南可用于帮助为特定目的选择和表征合适的纤维蛋白原起始材料。并非所有测试或参数都适用于纤维蛋白原的所有用途。 5.2 本指南中描述的纤维蛋白原可用于各种类型的医疗产品，包括但不限于植入物、组织- 工程医疗产品（TEMP）和细胞、药物或DNA传递载体。本指南中的建议不得解释为保证任何组织工程医疗产品的成功临床应用。 5.3 在确定纤维蛋白原是否符合在TEMP中使用的要求时，应考虑相关监管机构或与TEMP产品的生产、监管和批准相关的其他适当指南（指南 E1298 实践 F981 实践 F1983 ).

1.1 This guide covers the evaluation of porcine fibrinogen suitable for use in biomedical or pharmaceutical applications including, but not limited to, tissue-engineered medical products (TEMPs). 1.2 This guide addresses key parameters relevant for functionality, characterization, and purity of porcine fibrinogen. 1.3 As with any material, some characteristics of porcine fibrinogen may be altered by processing techniques, such as electrospinning ( 1 ) 2 and sterilization, required for the production of a specific formulation or device. Therefore, properties of fabricated forms of this protein should be evaluated using test methods that are appropriate to ensure safety and efficacy and are not addressed in this guide. 1.4 The primary focus of this document is fibrinogen derived from porcine blood, which is similar to human fibrinogen. The biggest advantage that pigs have over other species (such as cattle, sheep, goats, elk, and deer) is that they are less likely to transmit transmissible spongiform encephalitis (TSE) (ISO 22442-1 Annex D; WHO Guidelines, 2003; WHO Guidelines, 2006; WHO Guidelines, 2010). The document may also discuss fibrinogen from other sources when useful information is available. Fibrin is also discussed in some sections. 1.5 Units— The values stated in SI units are to be regarded as the 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 ====== 5.1 The purpose of this guide is to provide guidance on characterization of the properties of porcine fibrinogen as a starting material for surgical implants and as a matrix for tissue-engineered medical products (TEMPs). This guide contains a set of physical and chemical parameters directly related to the function of porcine fibrinogen. This guide can be used to help select and characterize appropriate fibrinogen starting materials for specific purposes. Not all tests or parameters are suitable for all uses of fibrinogen. 5.2 Fibrinogen described in this guide may be used in various types of medical products including, but not limited to, implants, tissue-engineered medical products (TEMPs), and cell, drug, or DNA delivery vectors. The recommendations in this guide shall not be construed to guarantee the successful clinical application of any tissue-engineered medical product. 5.3 In determining whether fibrinogen meets the requirements for use in a TEMP, the relevant regulatory authorities or other appropriate guidelines relating to the production, regulation, and approval of TEMP products shall be taken into account (Guide E1298 , Practice F981 , Practice F1983 ).