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.


animal models; biomaterials; cartilage; cartilage regeneration; cartilage repair; defect generation; devices; implants; in vivo; mechanical testing; synthetic biomaterials; TEMPs


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.


Developed by Subcommittee: F04.44

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 07-06-2023

Technical Contact: Anthony Ratcliffe

Item: 000