ASTM F 2211 : 2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Classification for Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
Hardcopy , PDF
04-01-2013
English
01-10-2004
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
F 04
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| DocumentType |
Standard
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| Pages |
8
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| PublisherName |
American Society for Testing and Materials
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
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.
| ASTM F 2383 : 2011 | Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) (Withdrawn 2020) |
| ASTM F 3225 : 2017 | Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2903 : 2011 | Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020) |
| ASTM F 3223 : 2017 | Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction |
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