1.1 本指南旨在为参与组织工程医疗产品（TEMP）开发、生产、交付和监管的个人和组织提供资源，用于血管的外科修复、置换、分流和/或旁路。本指南适用于与 体外 TEMP血管移植物的评估。 体外 细胞特征和 体内 测试不在本标准指南的范围内。 1.2 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者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。 1.3 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 减轻血管阻塞或动脉瘤相关血管壁削弱的病理效应的一种常见疗法是改变病变血管区域的血流路径。自体和非自体移植物常被用作外科血管替代物，以实现这种治疗干预。血管移植物TEMP也可用于这些目的。 它们也可用于建立或修正动静脉分流。 4.2 冠状动脉、颈动脉、肾动脉、髂总动脉、髂骨外动脉、股浅动脉和腘动脉是通常需要搭桥手术的血管部位。 4.3 TEMP可以由生物产品（例如，细胞、器官和组织）、生物材料（例如，由聚合物或胶原蛋白组成的基质和支架）、生物分子（例如，重组蛋白、天然/生物蛋白、氨基酸、肽、脂肪酸、糖和其他大分子）及其各种组合组成（见术语 312层 ). 分类中列出了TEMP的示例 2211层 . 4.4 TEMP可用于通过改善生物修复和/或重建、调节修复部位的机械负荷或这些机制的组合来促进手术结果。 4.5 改善手术结果的临床证据可能包括开放性、翻修手术发生率降低、植入物感染率降低以及术后功能改善。

1.1 This guide is intended as a resource for individuals and organizations involved in the development, production, delivery, and regulation of tissue engineered medical products (TEMPs) intended for use in the surgical repair, replacement, shunting, and/or bypass of blood vessels. This guide is intended for use related to the in vitro assessment of TEMP vascular grafts. In vitro cellular characterization and in vivo testing are not within scope for this standard guide. 1.2 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. 1.3 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 A common therapy to mitigate the pathological effects of blood vessel occlusion or aneurysm-related vascular wall weakening is to reroute blood flow around the diseased vascular regions. Autologous and non-autologous grafts are often used as vascular substitutes surgically to achieve this therapeutic intervention. Vascular graft TEMPs may also be used for these purposes. They may also be used to create or revise arteriovenous shunts. 4.2 Coronary, carotid, renal, common iliac, external iliac, superficial femoral, and popliteal arteries are examples of vascular sites commonly requiring bypass surgery. 4.3 TEMPs may be composed of biological products (for example, cells, organs, and tissues), biomaterials (for example, substrates and scaffolds composed of polymers or collagen), biomolecules (for example, recombinant proteins, native/biological proteins, amino acids, peptides, fatty acids, sugars, and other macromolecules), and various combinations thereof (see Terminology F2312 ). Examples of TEMPs are listed in Classification F2211 . 4.4 TEMPs may be used with the intent of facilitating the surgical outcome by improving the biological repair and/or reconstruction, by accommodating the mechanical loads at the repair site, or by a combination of these mechanisms. 4.5 Clinical evidence of improved surgical outcomes may include patency, reduced incidence of revision surgery, reduced rate of implant infection, and improved functionality after surgery.