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ASTM International - ASTM F2383-11

Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) (Withdrawn 2020)

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Organization: ASTM International
Publication Date: 1 March 2011
Status: inactive
Page Count: 9
ICS Code (Other standards related to laboratory medicine): 11.100.99
significance And Use:

TEMPs may be composed of biological products (for example, human cells, organs, tissues, derivatives, and processed biologics), biomaterials (for example, substrates and scaffolds composed of... View More

scope:

1.1 This guide is intended as a resource for individuals and organizations involved in the production, delivery, and regulation of tissue engineered medical products (TEMPs). The safety from contamination by potentially infectious adventitious agents is important in the development of all TEMPs as well as their components. This guide addresses how to assess safety risks associated with adventitious agents and their byproducts. These agents 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. Also excluded is patient follow-up testing.

1.2 This guide does 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. This guide does apply to cellular therapies regulated under 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 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 to determine the applicability of regulatory limitations prior to use.

Document History

ASTM F2383-11
March 1, 2011
Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) (Withdrawn 2020)
TEMPs may be composed of biological products (for example, human cells, organs, tissues, derivatives, and processed biologics), biomaterials (for example, substrates and scaffolds composed of...
April 1, 2005
Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
1.1 This guide is intended as a resource for individuals and organizations involved in the production, delivery, and regulation of tissue engineered medical products (TEMPs). The safety from...
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