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ASTM F 2383 : 2011

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) (Withdrawn 2020)

Available format(s)

Hardcopy , PDF

Withdrawn date

14-01-2020

Language(s)

English

Published date

01-03-2011

€67.30
Excluding VAT

Committee
F 04
DocumentType
Guide
Pages
9
PublisherName
American Society for Testing and Materials
Status
Withdrawn
Supersedes

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.

ASTM F 2900 : 2011 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
ASTM F 2903 : 2011 Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)

ASTM F 2386 : 2004 Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
ASTM F 2211 : 2002 Standard Classification for Tissue Engineered Medical Products (TEMPs)
ASTM F 2312 : 2004 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM E 1873 : 2004 Standard Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain Reaction Technique
ASTM F 2312 : 2011 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM E 1873 : 1997 Standard Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain Reaction Technique
ASTM F 2210 : 2002 : R2010 Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products (Withdrawn 2015)
ASTM F 2210 : 2002 Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
ASTM E 1873 : 2006 Standard Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain Reaction Technique (Withdrawn 2014)
ASTM F 2211 : 2013 Standard Classification for Tissue Engineered Medical Products (TEMPs)
ASTM F 2312 : 2010 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F 2211 : 2004 Standard Classification for Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
ASTM F 2312 : 2003 Standard Terminology Relating to Tissue Engineered Medical Products

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