ASTM F2383 PDF

Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)

ASTM F2383 – Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)

1.1 This guide is intended as a resource for individualsand organizations involved in the production, delivery, and regulation oftissue engineered medical products (TEMPs). The safety from contaminationby potentially infectious adventitious agents is important in the developmentof all TEMPs as well as their components. This guide addresses how to assesssafety risks associated with adventitious agents and their byproducts. Theseagents currently include bacteria, fungi, mycoplasma, viruses, endotoxins,transmissible spongiform encephalopathies (TSEs), and parasitic organisms.This guide does not address TEMPs with live animal cells, tissues or organs,or human cells, including stem cells, grown on any animal feeder cells. Alsoexcluded is patient follow-up testing.

1.2 This guide does not apply to any medical productsof human origin regulated by the U.S. Food and Drug Administration under 21CFR Parts 16 and 1270 and 21 CFR Parts 207, 807 and 1271. This guide does apply to cellular therapies regulatedunder the PHS (Public Health Service) act.

1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4 This standard does not purport to address all ofthe safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practicesand to determine the applicability of regulatory limitations prior to use.