ASTM-F2383 2005

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F2383-05 Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)

Published By	Publication Date	Number of Pages
ASTM	2005	9

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Categories: 11.100.99 - Other standards related to laboratory medicine, ASTM

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Description

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.

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
2	Significance and Use Sources of Risk
3	Processing and Process Validation
4	Final Product Adventitious Agents, Byproducts, and Detection Methods
5	TABLE 1
8	Keywords REFERENCES

Additional information

Standard Title	F2383-05 Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
Published Code	ASTM
Publication Date	2005
Pages Count	9
ICS Codes	11.100.99 - Other standards related to laboratory medicine

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ASTM-F2383 2005

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