Work Item
ASTM WK87037
New Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
1. Scope
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.
Keywords
animal models; biomaterials; cartilage; cartilage regeneration; cartilage repair; defect generation; devices; implants; in vivo; mechanical testing; synthetic biomaterials; TEMPs
Rationale
Existing standard lapsed, so need to update and resubmit as new standard with old standard number: F25451
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 07-06-2023
Technical Contact: Anthony Ratcliffe
Item: 000
Ballot:
Status: