【国外标准】 Standard Terminology Relating to Tissue Engineered Medical Products

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.FIG. 1 Relationships of the Fields of Tissue Engineering to Tissue Engineered Medical Products1.1 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 1270 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.