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ASTM International - ASTM F2211-04

Standard Classification for Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)

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Organization: ASTM International
Publication Date: 1 October 2004
Status: inactive
Page Count: 8
ICS Code (Other standards related to laboratory medicine): 11.100.99
significance And Use:

This classification outlines aspects of TEMPs which includes their individual components.

The categories outlined in this classification are intended to list, identify, and group the areas... View More

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.

Document History

September 15, 2021
Standard Classification for Tissue-Engineered Medical Products (TEMPs)
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...
October 1, 2013
Standard Classification for Tissue Engineered Medical Products (TEMPs)
4.1 This classification outlines aspects of TEMPs which includes their individual components. 4.2 The categories outlined in this classification are intended to list, identify, and group the areas...
ASTM F2211-04
October 1, 2004
Standard Classification for Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
This classification outlines aspects of TEMPs which includes their individual components. The categories outlined in this classification are intended to list, identify, and group the areas pertinent...
November 10, 2002
Standard Classification for Tissue Engineered Medical Products (TEMPs)
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...
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