1.1 该术语定义了基本术语，并介绍了与组织工程医疗产品（TEMPs）相关的科学领域的关系。F04委员会定义了这些术语，其具体目的是统一临时工标准中使用的语言。 1.2 此处定义的术语和关系仅限于临时工。它们不适用于美国监管的任何人类来源的医疗产品。食品药品监督管理局根据21 CFR第16部分和21 CFR第207、807和1271部分。 1.3 本标准中的术语和命名法是为了统一临时标准中使用的语言，而不是用于受管制医疗产品的标签。 1.4 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 1.5 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》中确立的国际公认的标准化原则制定的。 ======意义和用途====== 3.1 对临时工标准的需求也促使了对定义的需求。该术语阐述了最常用术语的定义，并指定了应用于组织工程以开发临时工的科学和组件之间的关系。这些术语的使用和对这些关系的理解将用通用语言统一ASTM临时工标准，使得这些标准的用户可以更精确地理解和解释这些标准。特定于TEMP标准的术语也将酌情在相应标准中定义。 3.2 定义术语- 术语的定义范围很广，以涵盖这些被称为临时工的新产品。例如，《人类体细胞治疗和基因治疗指南》中所述的体细胞治疗的定义 ( 1 ) 3 在这个术语中是公认的。然而，出于含有细胞的TEMPs的目的，我们添加了更广泛的“细胞”定义，并且不限于活细胞的使用。 3.3 临时工的临床效果- 该术语的使用者应注意，关于临时工的临床效果所使用的术语，例如，患者病况的“改变或修饰”，也可解释为“增强、增强、增强、增强”。输入、转换、改变、改进或补充。”类似地，“修复”也可以用来表示“恢复” 3.4 中的图表 图1 显示了临时工的组成部分与组织工程中用于创建临时工的科学领域（例如，技术和原理）的关系。某些TEMPs可以是组织工程化的或产生的 体外 通过使用特定的组件和科学为用户创造一个现成的温度。其它临时工可通过设计要求用户将部件放置在患者体内(即， 体内 ）依靠患者的再生潜能来实现产品的主要预期目的。用于治疗性临床应用的TEMP的预期是具有治疗效果，特别是修复、修饰或再生受体的细胞、组织和器官或其结构和功能。这种温度可用于人类和非人类应用。在其他应用中，TEMP可用于诊断性临床应用或两者，以实现细胞、组织和器官功能的研究结果。

1.1 This terminology defines basic terms and presents the relationships of the scientific fields related to Tissue Engineered Medical Products (TEMPs). Committee F04 has defined these terms for the specific purpose of unifying the language used in standards for TEMPs. 1.2 The terms and relationships defined here are limited to TEMPs. They do not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 21 CFR Parts 207, 807, and 1271. 1.3 The terms and nomenclature presented in this standard are for the specific purposes of unifying the language used in TEMP standards and are not intended for labeling of regulated medical products. 1.4 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. 1.5 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 ====== 3.1 The need for standards regarding TEMPs has also prompted a need for definitions. This terminology sets forth definitions of the most commonly used terms and specifies the relationship among the sciences and components applied in tissue engineering to develop TEMPs. Use of these terms and an understanding of these relationships will unify the ASTM TEMPs standards with a common language such that the users of these standards can understand and interpret the standards more precisely. Terms specific to a TEMP standard will also be defined within the respective standard as appropriate. 3.2 Defining Terms— Terms are defined with a broad scope to encompass these new products known as TEMPs. For instance, the definition for somatic cell therapy as stated in the “Guidance for Human Somatic Cell Therapy and Gene Therapy” ( 1 ) 3 is recognized in this terminology. However, for the purposes of TEMPs that contain cells, we have added the definition of “cell” which is much broader and not limited to the use of living cells. 3.3 Clinical Effects of TEMPs— The users of this terminology should note that terms used regarding the clinical effects of TEMPs, for instance, “modify or modification” of the patient's condition, may also be interpreted to “enhance, augment, transform, alter, improve, or supplement.” Similarly, “repair” may also serve to mean “restore.” 3.4 The diagram in Fig. 1 shows the relationships of components of TEMPs and of the fields of science (for example, technologies and principles) used in tissue engineering to create TEMPs. Certain TEMPs may be tissue engineered or produced in vitro by using specific components and sciences to create an off-the-shelf TEMP for the users. Other TEMPs may by design require the users to place the components inside the patient, (that is, in vivo ) to rely upon the patient's regenerative potential to achieve the product's primary intended purpose. The expectation of a TEMP used for therapeutic clinical applications is to have a therapeutic effect, specifically to repair, modify or regenerate the recipient's cells, tissues, and organs or their structure and function. Such a TEMP may be used for human and non-human applications. In other applications, a TEMP may be used in diagnostic clinical applications, or both, to achieve an investigative outcome of the function of the cells, tissues, and organs.