1.1 该分类概述了将作为标准开发的组织工程医疗产品的各个方面。这种分类不包括传统的器官和组织移植以及作为细胞治疗的单独活细胞移植。 1.2 该分类不适用于美国食品和药物管理局根据21 CFR第16和1270部分以及21 CFR第207、807和1271部分监管的任何人类来源的医疗产品。 1.3 本标准无意解决其他标准中涵盖的特定组件。 本标准不涉及与医疗产品使用相关的任何安全领域。 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、健康和环境实践，并确定监管限制的适用性。 1.4 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 该分类概述了TEMP的各个方面，包括其各个组成部分。 4.2 本分类中概述的类别旨在列出、识别和分组与组织工程医疗产品相关的领域。该分类将由组织工程医疗产品小组委员会用于组织制定组织工程领域标准、TEMP及其使用协议。 新组织工程技术产品的开发需要创建和实施新标准 ( 1. ) . 5. 4.3 由于TEMP中使用的组件之间可能会发生相互作用，因此需要新的标准描述、测试方法和实践来帮助评估这些相互作用。任何给定温度的总体风险程度由证明产品安全性和有效性所需的测试数量和类型反映。

1.1 This classification outlines the aspects of tissue-engineered medical products that will be developed as standards. This classification excludes traditional transplantation of organs and tissues as well as transplantation of living cells alone as cellular therapies. 1.2 This classification does not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271. 1.3 This standard does not purport to address specific components covered in other standards. Any safety areas associated with the medical product's use will not be addressed in this standard. 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. 1.4 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 This classification outlines aspects of TEMPs which includes their individual components. 4.2 The categories outlined in this classification are intended to list, identify, and group the areas pertinent to tissue-engineered medical products. This classification will be used by the Tissue-Engineered Medical Products subcommittees for the organization of the development of standards for the field of tissue engineering, TEMPs, and protocols for their use. The development of products from the new tissue engineering technologies necessitates creation and implementation of new standards ( 1 ) . 5 4.3 Since interactions may occur among the components used in TEMPs, new standard descriptions, test methods, and practices are needed to aid the evaluation of these interactions. The degree of overall risk for any given TEMP is reflected by the number and types of tests required to demonstrate product safety and efficacy.