Standard Classification for Tissue-Engineered Medical Products (TEMPs)

Importancia y uso:

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.

Subcomité:

F04.41

Referida por:

F3223-17, F3225-17R22

Volúmen:

13.01

Número ICS:

11.100.99 (Other standards related to laboratory medicine)

Palabras clave:

biomaterials; biomolecules; cells; classification; TEMPs; tissue engineering;