1. Scope
1.1 This practice covers the determination of the degree of gap junction intercellular communications (GJIC) of cells in tissue-engineered products (TEMPs) including ordinary biomaterials. 1.2 This practice is applicable for determining the degree of GJIC of the cells growth on the surface of biomaterials or when exposed to chemicals. 1.3 This practice is valuable for the biocompatibility of medical device materials because of the indication of the cell/tissue homeostasis including the signal transduction. 1.4 This practice is valuable for the estimation of tumor-promoting potential in materials, their constituents, and additives. It is also relevant to the tumor-promoting method described in part of F 748 and offers useful information considering the data with an in vivo/bioassay method. 1.5 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.
The field of tissue-engineered medical products may present some unique challenges in testing for biocompatibility. This practice may be the first to assess biocompatibility using cell signaling. It may have testing applications in other biocompatibility testing of materials for medical devices.
Keywords
gap junction; biocompatibility; cellular communication; tissue engineering; TEMPs
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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