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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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D570 Test Method for Water Absorption of Plastics
F1635 Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
F2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
F2210 Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
F2211 Classification for Tissue Engineered Medical Products (TEMPs)
F2212 Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
F2312 Terminology Relating to Tissue Engineered Medical Products
F2386 Guide for Preservation of Tissue Engineered Medical Products (TEMPs)
F2739 Guide for Quantifying Cell Viability within Biomaterial Scaffolds
ISO StandardsISO 10993-1 Biological evaluation of medical devices ISO 13022:2012 Medical products containing viable human cellsApplication of risk management and requirements for processing practices ISO 18362:2016
ICS Number Code 11.040.40 (Implants for surgery, prosthetics and orthotics)
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ASTM F3223-17, Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction, ASTM International, West Conshohocken, PA, 2017, www.astm.orgBack to Top