【国外标准】 Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction

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.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.