ASTM F 2312 : 2011 : REDLINE
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Terminology Relating to Tissue Engineered Medical Products
25-10-2024
English
01-04-2011
Important note : Users cannot be edited or removed once added to your Multi user PDF.CONTAINED IN VOL. 13.01, 2015 States basic terms and presents the relationships of the scientific fields related to Tissue Engineered Medical Products (TEMPs).
| Committee |
F 04
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| DocumentType |
Redline
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| Pages |
10
|
| PublisherName |
American Society for Testing and Materials
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| Status |
Superseded
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| SupersededBy |
1.1 This terminology defines basic terms and presents the relationships of the scientific fields related to Tissue Engineered Medical Products (TEMPs). Committee F04 has defined these terms for the specific purpose of unifying the language used in standards for TEMPs.
1.2 The terms and relationships defined here are limited to TEMPs. They do 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 The terms and nomenclature presented in this standard are for the specific purposes of unifying the language used in TEMP standards and are not intended for labeling of regulated medical products.
1.4 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 limitations prior to use.
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| ASTM F 2903 : 2011 | Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020) |
| DIN ISO 13022 E : 2014 | MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012) |
| ANSI/AAMI/ISO 13022:2012 | MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES |
| BS PAS 84(2008) : 2008 | REGENERATIVE MEDICINE - GLOSSARY |
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| ASTM F 3142 : 2016 | Standard Guide for Evaluation of <emph type="bdit">in vitro</emph> Release of Biomolecules from Biomaterials Scaffolds for TEMPs |
| ASTM F 2150 : 2013 : REDLINE | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ASTM F 2383 : 2011 : REDLINE | Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) |
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| CFR 21(PTS1-99) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99 |
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