ASTM-F2210:2002 Edition

$40.63

F2210-02 Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products

Published By	Publication Date	Number of Pages
ASTM	2002	6

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Categories: 11.040.01 - Medical equipment in general, ASTM

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Description

ASTM F2210-02

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

ASTM F2210

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.

Keywords

cell and tissue engineering; cells; organs; processing of cells; tissue engineered medical products; tissues; tissues and organs

ICS Code

ICS Number Code 11.040.01 (Medical equipment in general)

DOI: 10.1520/F2210-02

PDF Catalog

PDF Pages	PDF Title
1	Scope Terminology
2	Significance and Use Facility, Reagents, and Procedures
4	Keywords REFERENCES

Additional information

Standard Title	F2210-02 Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
Published Code	ASTM
Publication Date	2002
Pages Count	6
ICS Codes	11.040.01 - Medical equipment in general