ASTM F2211-13(2021) PDF

Scope: 1.1 This classification outlines the aspects of tissueengineered 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.

ASTM F2211-13(2021) Referenced Document

ASTM F2027 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ASTM F2064 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F2103 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
ASTM F2131 Standard Test Method for In Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line*， 2021-10-01 Update
ASTM F2150 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

2021 ASTM F2211-13(2021) Standard Classification for Tissue-Engineered Medical Products (TEMPs)
2013 ASTM F2211-13 Standard Classification for Tissue Engineered Medical Products (TEMPs)
2004 ASTM F2211-04 Standard Classification for Tissue Engineered Medical Products (TEMPs)
2002 ASTM F2211-02 Standard Classification for Tissue Engineered Medical Products (TEMPs)