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ASTM F 2210 Document Information:
Title
Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
ASTM International
Publication Date:
Nov 10, 2002
Scope:
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.
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).
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
- orgas
- processing of cells
- tissue engineered medical products
- tissues
- tissues and organs
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