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

ASTM-F2211 - 2013 EDITION - CURRENT
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Standard Classification for Tissue Engineered Medical Products (TEMPs)
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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 Number Code 11.100.99 (Other standards related to laboratory medicine)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.01 (Medical equipment in general)

11.100.99 (Other standards related to laboratory medicine)

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Document Number

ASTM-F2211-13

Revision Level

2013 EDITION

Status

Current

Modification Type

Reinstated

Publication Date

Jan. 1, 2014

Document Type

Classification

Page Count

8 pages

Committee Number

F04.41