ASTM F1088-04ae1
Historical Standard: ASTM F1088-04ae1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
SUPERSEDED (see Active link, below)
ASTM F1088
1. Scope
1.1 This specification covers chemical and crystallographic requirements for biocompatible beta-tricalcium phosphate (?-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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
American Society for Quality (ASQ) Document
International Organization for Standardization Document
ISO10993 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.United States Pharmacopeia (USP) Documents
Keywords
advanced ceramics; ? -TCP; beta-tricalcium phosphate; calcium phosphate material; ceramic; surgical implant; Alpha-tricalcium phosphate; Beta-tricalcium phosphate; Bone implant materials/applications--specifications; Ceramic materials/applications--specifications; Ceramic surgical materials/applications--specifications; Crystallographic characteristics; Orthopaedic medical devices--specifications; Tribasic calcium phosphate; Whitlockite;
ICS Code
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
DOI: 10.1520/F1088-04AE01
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