Name: ASTM F 2210 : 2002
Brand: ASTM
Price: 75.00 USD

ASTM F 2210 : 2002

Withdrawn

View Superseded by

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

Available format(s)

Hardcopy , PDF

Withdrawn date

09-30-2015

Language(s)

English

Published date

11-10-2002

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2015 Gives 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.

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.

Committee	F 04
DocumentType	Guide
Pages	6
ProductNote	Reconfirmed 2002
PublisherName	American Society for Testing and Materials
Status	Withdrawn
SupersededBy	ASTM F 2210 : 2002 : R2010

ASTM F 2902 : 2016 : EDT 1	Standard Guide for Assessment of Absorbable Polymeric Implants
ASTM F 2383 : 2011	Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) (Withdrawn 2020)
ASTM F 3225 : 2017	Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
ASTM F 2903 : 2011	Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)
ASTM F 3223 : 2017	Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction