Significance and Use
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.
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 (4) 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.
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.
1. Scope
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 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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Government Documents
21CFRParts207,807,an Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing (January 19, 2001)
Keywords
TEMPs (tissue engineered medical products); Terminology--medical/surgical systems/applications;
ICS Code
ICS Number Code 01.040.11 (Health care technology (Vocabularies)); 11.120.99 (Other standards related to pharmaceutics)
DOI: 10.1520/F2312-11
ASTM International is a member of CrossRef.
ASTM F2312