1.1 本指南旨在为参与生产、交付和监管组织工程医疗产品（TEMP）和用于膝半月板手术修复、置换和/或重建的其他组织的个人和组织提供资源。 1.2 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====== 5.1 膝半月板损伤是最常见的骨科问题之一。半月板损伤包括急性撕裂（如运动损伤）、慢性退行性撕裂、挤压/半脱位和/或作为膝盖老化过程的一部分或多次半月板手术的结果而发生的退行性功能障碍。 膝关节镜下半月板部分切除术（半月板部分切除术）是最常见的矫形手术。 5.2 由于半月板软骨保护作用的丧失，年轻人半月板完全或接近完全切除与早期膝骨关节炎风险增加有关。外侧半月板损伤往往比内侧损伤更严重。建议个体进行半月板修复、增强、移植和/或重建，以恢复半月板的软骨保护作用，缓解疼痛，并预防退行性膝骨关节炎。 TEMP在提高半月板修复和/或重建手术效果方面的潜力已得到认可。 5.3 膝关节和颞下颌关节（TMJ）是具有半月板结构的关节。 5.4 TEMP可以通过改善植入部位的生物修复、在缺损部位提供机械功能或通过这些机制的组合来提高手术效果。 5.5 改善手术结果可能包括改善与术前相比的功能- 手术条件，缩短术后恢复时间，缓解疼痛，恢复正常日常活动，鼓励组织生长到缺损部位，恢复半月板的机械功能，延缓骨关节炎的进展，或两者的任何组合。

1.1 This guide is intended as a resource for individuals and organizations involved in the production, delivery, and regulation of tissue engineered medical products (TEMPs) and other tissues intended for use in the surgical repair, replacement, and/or reconstruction of the knee meniscus. 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 and health 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 ====== 5.1 Injuries to the knee meniscus are one of the most common orthopaedic problems. Meniscus injures include acute tears (such as occur in sports injuries), chronic degenerative tears, extrusion/subluxation, and/or degenerative dysfunction that occurs as part of the knee aging process or as a result of multiple meniscus surgeries. Knee arthroscopy for partial excision of the knee meniscus (partial meniscectomy) is the most commonly performed orthopaedic procedure. 5.2 Complete or near complete excision of the meniscus in a young individual is associated with an early increased risk of knee osteoarthritis due to the loss of the meniscus chondroprotective effects. Lateral meniscal injuries tend to be more severe than medial injuries. Meniscus repair, augmentation, transplantation, and/or reconstruction is recommended in individuals to restore the chondroprotective effect of the meniscus, relieve pain, and prevent degenerative knee osteoarthritis. The potential of TEMPs to enhance the outcome of the surgical meniscus repair and/or reconstruction has been recognized. 5.3 The knee joint and temporomandibular joint (TMJ) are examples of joints with meniscal structures. 5.4 TEMPS may be used with the intent of enhancing the surgical outcome by improving the biological repair at the site of implantation, by providing mechanical function at a defect site, or by a combination of these mechanisms. 5.5 Improving surgical outcome may include improving function relative to the pre-operative condition, shortening the recovery time after surgery, relieving pain, enabling return to normal daily activities, encouraging tissue growth into the defect site, restoring the mechanical function of the meniscus, delaying the progression of osteoarthritis, or any combination thereof.