ASTM F3223-2017 膝關(guān)節半月板手術(shù)修復和/或重建用組織工程醫用產(chǎn)品鑒定與評估指南 Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction

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.