ASTM F2383

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 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.

2. Referenced Documents

ASTM Standards
E1873 Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain Reaction Technique
F2210 Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
F2211 Classification for Tissue Engineered Medical Products (TEMPs)
F2312 Terminology Relating to Tissue Engineered Medical Products
F2386 Guide to Preservation of Tissue Engineered Medical Products (TEMPs)
ANSI/AAMI Standard
ST72 Bacterial Endotoxin--Test Methodologies, Routine Monitoring and Alternatives to Batch Testing
Federal Regulations
21CFR1271 Human Cells, Tissues, and Cellular and Tissue-Based Products
MDA Standard
CodeofPractice for the Production of Human-Derived Therapeutic Products
U. S. Pharmacopeia Document
UnitedStatesPharmacopeia (USP), Edition XXIV (24)

Index Terms

adventitious agents; microorganisms; TEMPs; testing; ICS Number Code 11.100.99 (Other standards related to laboratory medicine)

Citing ASTM Standards

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