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ASTM International - ASTM F2210-02

Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products

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Organization: ASTM International
Publication Date: 10 November 2002
Status: inactive
Page Count: 6
ICS Code (Medical equipment in general): 11.040.01
significance And Use:

This guide describes the general product development criteria and analyses applicable to processing of cells, tissues, and organs used for the production of TEMPs. For the purposes of this guide,... View More

scope:

1.1 This guide describes the processing, characterization, production, and quality assurance of cells, tissues, and organs used for Tissue Engineered Medical Products (TEMPs). It concerns aspects of processing activities for cells, tissues, and organs to be further processed. These aspects include: (1) cell, tissue, and organ processing (that is, facility, reagents, and procedures for receipt, inspection, and storage; tissue culture components, biological risk factors, and processing area), (2) donors (human and nonhuman) and screening, and (3) cell, tissue, and organ characterization and processing.

1.2 This guide does not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration (FDA) under 21 CFR Parts 16 and 1270 (1) and 21 CFR Parts 207, 807, and 1271 (2).

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 determine the applicability of regulatory requirements prior to use.

Document History

December 1, 2010
Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products (Withdrawn 2015)
1.1 This guide describes the processing, characterization, production, and quality assurance of cells, tissues, and organs used for Tissue Engineered Medical Products (TEMPs). It concerns aspects of...
ASTM F2210-02
November 10, 2002
Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
1.1 This guide describes the processing, characterization, production, and quality assurance of cells, tissues, and organs used for Tissue Engineered Medical Products (TEMPs). It concerns aspects of...
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