ASTM-F2386 Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)

ASTM-F2386 - 2004 EDITION - CANCELLED
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Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
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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 Number Code 11.100 (Laboratory medicine)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.100 (Laboratory medicine)

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Document Number

ASTM-F2386-04

Revision Level

2004 EDITION

Status

Cancelled

Modification Type

Withdrawn

Publication Date

June 1, 2004

Document Type

Guide

Page Count

5 pages

Committee Number

F04.43