Name: ASTM F 2451 : 2005
Brand: ASTM
Price: 75.00 USD

ASTM F 2451 : 2005

Superseded

View Superseded by

Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

04-01-2005

Publisher

American Society for Testing and Materials

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 the 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 2005
PublisherName	American Society for Testing and Materials
Status	Superseded
SupersededBy	ASTM F 2451 : 2005 : R2010

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