ASTM F2211 - 13 - Standard Classification for Tissue Engineered Medical Products (TEMPs)

ASTM F2211 - 13

Standard Classification for Tissue Engineered Medical Products (TEMPs)

Status : Current   Published : January 2013

Format
PDF

Format
HARDCOPY



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.




Standard NumberASTM F2211 - 13
TitleStandard Classification for Tissue Engineered Medical Products (TEMPs)
StatusCurrent
Publication Date10 January 2013
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Biomaterials, Biomolecules, Cells, Classification, TEMPs, Tissue-engineering
ICS01.040.11
PublisherASTM
FormatA4
DeliveryYes
Pages8
File Size0 KB
Price£40.00


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