ASTM-F2211:2021 Edition

$34.13

F2211-13(2021) Standard Classification for Tissue-Engineered Medical Products (TEMPs)

Published By	Publication Date	Number of Pages
ASTM	2021

Guaranteed Safe Checkout

Categories: 11.100.99 - Other standards related to laboratory medicine, ASTM

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

Description

ASTM F2211-13-Reapproved2021

Active Standard: Standard Classification for Tissue-Engineered Medical Products (TEMPs)

ASTM F2211

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 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.

1.4 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.

Keywords

biomaterials; biomolecules; cells; classification; TEMPs; tissue engineering;

ICS Code

ICS Number Code 11.100.99 (Other standards related to laboratory medicine)

DOI: 10.1520/F2211-13R21

Additional information

Standard Title	F2211-13(2021) Standard Classification for Tissue-Engineered Medical Products (TEMPs)
Published Code	ASTM
Publication Date	2021
ICS Codes	11.100.99 - Other standards related to laboratory medicine