ASTM-F2211:2004 Edition

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F2211-04 Standard Classification for Tissue Engineered Medical Products (TEMPs)

Published By	Publication Date	Number of Pages
ASTM	2004	8

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Categories: 11.100.99 - Other standards related to laboratory medicine, ASTM

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Description

ASTM F2211-04

Historical Standard: Standard Classification for Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)

ASTM F2211

Scope

1.1 This classification outlines the aspects of tissue engineered medical products that will be developed as standards. This classification excludes traditional transplantation of organs and tissues as well as transplantation of living cells alone as cellular therapies.

1.2 This classification does not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271.

1.3 This standard does not purport to address specific components coverd in other standards. Any safety areas associated with the medical product’s use will not be addressed in this standard. 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; biomolecules; cells; classification; TEMPs; tissue-engineering

ICS Code

ICS Number Code 11.100.99 (Other standards related to laboratory medicine)

DOI: 10.1520/F2211-04

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
2	Significance and Use Classification of Tissue Engineered Medical Products Components
3	Characterization of TEMP Interactions
4	Assessment Normal Biology Delivery Systems
5	Microbiological Safety and Adventitious Agents Clinical Trials
6	Keywords X1. RATIONALE X1.1 X1.2 X2. BACKGROUND X2.1 Background of Tissue Engineering X2.2 Human Systems
7	X2.3 Aspects of TEMPs X2.4 TEMPs Examples
8	REFERENCES FIG. X2.1

Additional information

Standard Title	F2211-04 Standard Classification for Tissue Engineered Medical Products (TEMPs)
Published Code	ASTM
Publication Date	2004
Pages Count	8
ICS Codes	11.100.99 - Other standards related to laboratory medicine