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F2211

Standard Classification for Tissue-Engineered Medical Products (TEMPs)

active, Most Current
Publication Date: 1 October 2013
Status: active
Page Count: 8
ICS Code (Other standards related to laboratory medicine): 11.100.99
ICS Code (Medical equipment in general): 11.040.01
scope:

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.

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.

This standard does not purport to address specific components covered 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

 

 

Document History

October 1, 2013
Standard Classification for Tissue Engineered Medical Products (TEMPs)
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...
F2211
October 1, 2013
Standard Classification for Tissue-Engineered Medical Products (TEMPs)
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...
October 1, 2004
Standard Classification for Tissue Engineered Medical Products (TEMPs)
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...
November 10, 2002
Standard Classification for Tissue Engineered Medical Products (TEMPs)
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...

References

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