ASTM F 3223 : 2017
Current
The latest, up-to-date edition.
Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
Hardcopy , PDF
English
01-03-2017
Important note : All end users must be registered with an Account prior to user licenses being assigned.This guide is intended as a resource for individuals and organizations involved in the production, delivery, and regulation of tissue engineered medical products (TEMPs) and other tissues intended for use in the surgical repair, replacement, and/or reconstruction of the knee meniscus.
| Committee |
F 04
|
| DocumentType |
Guide
|
| Pages |
8
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Current
|
1.1This guide is intended as a resource for individuals and organizations involved in the production, delivery, and regulation of tissue engineered medical products (TEMPs) and other tissues intended for use in the surgical repair, replacement, and/or reconstruction of the knee meniscus.
1.2This 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.
1.3This 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| ASTM F 2386 : 2004 | Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013) |
| ASTM F 2150 : 2013 : REDLINE | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ASTM F 2312 : 2011 : REDLINE | Standard Terminology Relating to Tissue Engineered Medical Products |
| ASTM F 2211 : 2002 | Standard Classification for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2150 : 2019 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products |
| ASTM F 2312 : 2004 | Standard Terminology Relating to Tissue Engineered Medical Products |
| ASTM F 2212 : 2011 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2312 : 2024 | Standard Terminology Relating to Tissue Engineered Medical Products |
| ASTM F 2739 : 2019 | Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds |
| ASTM F 2212 : 2011 : REDLINE | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 1635 : 2016 | Standard Test Method for <emph type="bdit">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| ASTM F 2739 : 2008 | Standard Guide for Quantitating Cell Viability Within Biomaterial Scaffolds |
| ASTM F 2212 : 2002 : R2007 : EDT 1 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2212 : 2019 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2211 : 2013 : R2021 | Standard Classification for Tissue-Engineered Medical Products (TEMPs) |
| ASTM F 2212 : 2002 | Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2312 : 2011 | Standard Terminology Relating to Tissue Engineered Medical Products |
| ASTM F 1635 : 2016 : REDLINE | Standard Test Method for <emph type="bdit">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| ASTM F 2210 : 2002 : R2010 | Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products (Withdrawn 2015) |
| ASTM F 2150 : 2013 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ISO 13022:2012 | Medical products containing viable human cells — Application of risk management and requirements for processing practices |
| ASTM F 2150 : 2002 : EDT 1 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ASTM F 2312 : 2011 : R2020 | Standard Terminology Relating to Tissue Engineered Medical Products |
| ASTM F 2210 : 2002 | Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products |
| ASTM F 2212 : 2008 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 1635 : 1995 | Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical Implants |
| ASTM F 1635 : 2004 | Standard Test Method for <i>in Vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| ASTM F 2739 : 2016 | Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ASTM F 2212 : 2002 : R2007 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2212 : 2009 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2211 : 2013 | Standard Classification for Tissue Engineered Medical Products (TEMPs) |
| ASTM D 570 : 2022 | Standard Test Method for Water Absorption of Plastics |
| ISO 18362:2016 | Manufacture of cell-based health care products Control of microbial risks during processing |
| ASTM F 2312 : 2010 | Standard Terminology Relating to Tissue Engineered Medical Products |
| ASTM F 2150 : 2007 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ASTM D 570 : 1998 : R2018 | Standard Test Method for Water Absorption of Plastics |
| ASTM F 1635 : 2011 | Standard Test Method for <i>in vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| ASTM F 2211 : 2004 | Standard Classification for Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013) |
| ASTM F 2212 : 2008 : EDT 1 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2312 : 2003 | Standard Terminology Relating to Tissue Engineered Medical Products |
| ASTM F 1635 : 2004 : REV A | Standard Test Method for <i>in Vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
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