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ASTM F 2721 : 2009 : R2014

Current
Current

The latest, up-to-date edition.

Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

16-03-2015

CONTAINED IN VOL. 13.01, 2015 Defines general guidelines for the in vivo assessment of tissue engineered medical products (TEMPs) intended to repair or regenerate bone.

1.1This guide covers general guidelines for the in vivo assessment of tissue-engineered medical products (TEMPs) intended to repair or regenerate bone. TEMPs included in this guide may be composed of natural or synthetic biomaterials (biocompatible and biodegradable) or composites thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. The models described in this guide are segmental critical size defects which, by definition, will not fill with viable tissue without treatment. Thus, these models represent a stringent test of a material’s ability to induce or augment bone growth.

1.2Guidelines include a description and rationale of various animal models including rat (murine), rabbit (leporine), dog (canine), goat (caprine), and sheep (ovine). Outcome measures based on radiographic, histologic, and mechanical analyses are described briefly and referenced. The user should refer to specific test methods for additional detail.

1.3This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of the product. ASTM standards for these steps are available in the Referenced Documents (Section 2).

1.4The use of any of the methods included in this guide may not produce a result that is consistent with clinical performance in one or more specific applications.

1.5Other pre-clinical methods may also be appropriate and this guide is not meant to exclude such methods. The material must be suitable for its intended purpose. Additional biological testing in this regard would be required.

1.6The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.7This 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.

Committee
F 04
DocumentType
Guide
Pages
14
ProductNote
Reconfirmed 2014
PublisherName
American Society for Testing and Materials
Status
Current
SupersededBy
Supersedes

ASTM F 2529 : 2013 : R2021 Standard Guide for  <emph type="ital"> in vivo</emph> Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
ASTM F 2529 : 2013 Standard Guide for <emph type="bdit">in vivo</emph> Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)

ASTM F 1983 : 1999 : R2008 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
ASTM F 2150 : 2013 : REDLINE Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
ASTM F 565 : 2004 : R2009 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
ASTM F 1983 : 1999 : R2003 Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications
ASTM F 1983 : 2014 : REDLINE Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
ASTM F 561 : 2013 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
ASTM F 2150 : 2019 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
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 565 : 2021 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
CFR 21(PTS600-799) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 600-799
ASTM F 1983 : 2014 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
ASTM F 2150 : 2007 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
ASTM F 565 : 2004 : R2018 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
ASTM F 1983 : 1999 Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications

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