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ASTM F 3223 : 2017

Current
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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-03-2017

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.

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.

Committee
F 04
DocumentType
Guide
Pages
8
PublisherName
American Society for Testing and Materials
Status
Current

ASTM F 2386 : 2004 Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)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 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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