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ASTM F2211-02

Historical Revision

Standard Classification for Tissue Engineered Medical Products (TEMPs)

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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 CDR 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.


SDO ASTM: ASTM International
Document Number F2211
Publication Date Nov. 10, 2002
Language en - English
Page Count 8
Revision Level 02
Supercedes
Committee F04.41
Publish Date Document Id Type View
Oct. 1, 2013 F2211-13 Revision
Oct. 1, 2004 F2211-04 Revision
Nov. 10, 2002 F2211-02 Revision
Sept. 15, 2021 F2211-13R21 Reaffirmation