ASTM F1088-04ae1 - 1.5.2004
 
1. Scope

1.1 This specification covers chemical and crystallographic requirements for biocompatible beta-tricalcium phosphate (β-TCP) for surgical implant applications. For a material to be identified as medical grade beta-tricalcium phosphate, it must conform to this specification (see Appendix X1).

 
2. Referenced Documents

ISO 10993

Biological Evaluation of Medical Devices Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.

C1

Specification of General Requirements for a Quality Program Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.

F981-23

Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

F748-16

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

Heavy Metals <231> Method 1