ASTM-F2386 2004

$40.63

F2386-04 Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs)

Published By	Publication Date	Number of Pages
ASTM	2004	5

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Category: ASTM

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Description

ASTM F2386-04

Withdrawn Standard: Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)

ASTM F2386

Scope

1.1 This guide covers the development of standards related to the preservation of cells, tissues, and tissue engineered medical products (TEMPs). Preservation techniques include freezing, vitrification, and hypothermic preservation. This guide discusses preservation, including issues of pre-preservation processing, the process of preservation, storage, transport, recovery, post-preservation processing, quality assurance, and process control.

1.2 This guide contains general guidelines for the preservation of cells, tissues, and tissue engineered medical products (TEMPs) and will identify more specific parameters relevant to the preservation of TEMPs.

1.3 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 and 21 CFR Parts 207, 807, and 1271.

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 determine the applicability of regulatory requirements prior to use.

Keywords

biomaterials; cell and tissue engineering; cells; tissue engineered medical products (TEMPs); tissues

ICS Code

ICS Number Code 11.100 (Laboratory medicine)

DOI: 10.1520/F2386-04

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
2	Summary of Guide Procedure
5	Keywords

Additional information

Standard Title	F2386-04 Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs)
Published Code	ASTM
Publication Date	2004
Pages Count	5