ASTM F 3225 : 2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
Hardcopy , PDF
28-09-2022
English
21-12-2017
Important note : Users cannot be edited or removed once added to your Multi user PDF.This guide is intended as a resource for individuals and organizations involved in the development, production, delivery, and regulation of tissue engineered medical products (TEMPs) intended for use in the surgical repair, replacement, shunting and/or bypass of blood vessels.
| Committee |
F 04
|
| DocumentType |
Guide
|
| Pages |
7
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy |
1.1This guide is intended as a resource for individuals and organizations involved in the development, production, delivery, and regulation of tissue engineered medical products (TEMPs) intended for use in the surgical repair, replacement, shunting and/or bypass of blood vessels. This guide is intended for use related to the in vitro assessment of TEMP vascular grafts. In vitro cellular characterization and in vivo testing are not within scope for this standard guide.
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, health, and environmental 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.
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| 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 2382 : 2004 : R2010 | Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT) |
| 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) |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ASTM F 2739 : 2019 | Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds |
| ASTM F 2382 : 2004 : EDT 1 | Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT) |
| ISO 7198:2016 | Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
| 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 2382 : 2017 | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) |
| 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) |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| 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 |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| 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 |
| 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) |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| 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 |
| ASTM F 2382 : 2004 | Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT) |
| 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) |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| 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 F 2382 : 2017 : EDT 1 | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) |
| 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 |
| ASTM F 2382 : 2018 | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.