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ASTM F 2451 : 2005 : R2010

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage (Withdrawn 2019)
Available format(s)

Hardcopy , PDF

Withdrawn date

16-01-2019

Language(s)

English

Published date

01-09-2010

CONTAINED IN VOL. 13.01, 2015 Defines general guidelines for the in vivo assessment of implantable devices intended to repair or regenerate articular cartilage.

1.1 This guide covers general guidelines for the in vivo assessment of implantable devices intended to repair or regenerate articular cartilage. Devices 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.

1.2 Guidelines include a description and rationale of various animal models utilizing a range of species such as rabbit (lupine), dog (canine), pig (porcine), goat (caprine), sheep (ovine), and horse (equine). Outcome measures based on histologic, biochemical, and mechanical analyses are briefly described and referenced. The user should refer to specific test methods for additional detail.

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

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

1.5 This 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 requirements prior to use.

Committee
F 04
DocumentType
Guide
Pages
9
ProductNote
Reconfirmed 2010
PublisherName
American Society for Testing and Materials
Status
Withdrawn
Supersedes

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 : 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
CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99

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