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ASTM-F2451:2010 Edition

ASTM-F2451:2010 Edition

$40.63

F2451-05(2010) Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage

Published By Publication Date Number of Pages
ASTM 2010 9
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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.

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
Terminology
2 Significance and Use
Animal Models
TABLE 1
4 Considerations for Defect Site
Considerations for Defect Type, Implant Fixation, and Joint Immobilization
5 Test Procedures
6 Evaluation and Results
7 Analysis
Keywords
REFERENCES

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