ASTM-F2210 Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products (Withdrawn 2015)

ASTM-F2210 - 2002 R10 EDITION - CANCELLED
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Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products (Withdrawn 2015)
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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; Processing cells/tissues/organs; TEMPs (tissue engineered medical products; ICS Number Code 11.100.99 (Other standards related to laboratory medicine)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.01 (Medical equipment in general)

11.100.99 (Other standards related to laboratory medicine)

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Document Number

ASTM-F2210-02(2010)

Revision Level

2002 R10 EDITION

Status

Cancelled

Modification Type

Withdrawn

Publication Date

Dec. 1, 2010

Document Type

Guide

Page Count

6 pages

Committee Number

F04.43