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ASTM F 2884 : 2012

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion (Withdrawn 2021)
Available format(s)

Hardcopy , PDF

Withdrawn date

21-01-2022

Language(s)

English

Published date

24-04-2012

CONTAINED IN VOL. 13.01, 2012 Defines general guidelines for the pre-clinical in vivo assessment of tissue-engineered medical products (TEMPs) intended to repair or regenerate bone in an interbody and/or posterolateral spinal environment.

1.1 This guide covers general guidelines for the pre-clinical in vivo assessment of tissue-engineered medical products (TEMPs) intended to repair or regenerate bone in an interbody and/or posterolateral spinal environment. TEMPs included in this guide may be composed of, but are not limited to, natural or synthetic biomaterials 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 document represent a stringent test of a materials ability to induce and/or augment bone growth in the spinal environment.

1.2 While clinically TEMPs may be combined with hardware for initial stabilization or other purposes, the focus of this guide is on the appropriateness of the animal model chosen and evaluation of the TEMP induced repair and as such does not focus on issues of hardware.

1.3 Guidelines include a description and rationale of various animal models for the in vivo assessment of the TEMP. The animal models utilize a range of species including rat (murine), rabbit (lapine), dog (canine), goat (caprine), pig (porcine), sheep (ovine), and non-human primate (primates). Outcome measures include in vivo assessments based on radiographic, histologic, CT imaging as well as subsequent in vitro assessments of the repair, including histologic analyses and mechanical testing. All methods are described briefly and referenced. The user should refer to specific test methods for additional detail.

1.4 This 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 Referenced Documents (Section 2).

1.5 The 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.

1.6 Other 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.

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

1.8 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

Committee
F 04
DocumentType
Guide
Pages
47
PublisherName
American Society for Testing and Materials
Status
Withdrawn
SupersededBy

ASTM F 3207 : 2017 Standard Guide for <emph type="bdit">in vivo</emph> Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model

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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