Standards

ASTM WK3551

(What is a Work Item? / How to Input to a Work Item)

Work Item: ASTM WK3551 - New Guide for Guide for the Assessment of Demineralized Bone Without Excipient


Developed by Subcommittee: F04.44 | Committee F04 Home | Contact Staff Manager



1. Scope

1.Scope 1.1These test methods cover general guidelines for assessment of the effectiveness of demineralized bone intended to induce new bone formation when implanted or injected in vivo. 1.2Test methods include a range of species and size including mice and rats. 1.3Test methods included herein are directed to assessing the potential of a given biomaterial to form bone when used in a clinical application and are not intended to include preparation and formation of biomaterials into devices or injectibles nor the sterilization and packaging of product(s) produced thereby. ASTM standards for these steps are available in section 2 below. 1.4This 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 involved in the practice of this standard and to determine the applicability of regulatory limitations prior to use.


Keywords

no keywords specificed:

The title and scope are in draft form and are under development within this ASTM Committee.

Citing ASTM Standards

[Back to Top]




Work Item Status:
Date Initiated:12-8-2003
Technical Contact: Alyce Linthurst-Jones

Status: Draft Under Development

Standards Tracker

Standards Subscriptions