ASTM F1088-87(1992)e1
Historical Standard: ASTM F1088-87(1992)e1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
SUPERSEDED (see Active link, below)
ASTM F1088
1. Scope
1.1 The specification defines the chemical and crystallographic properties of beta-tricalcium phosphate intended for surgical implantation. It also informs the user that manufacturers and distributors are obligated to meet certain federal requirements.
1.2 It has been found that material meeting this specification engenders an acceptable biocompatible response as defined in Practice F981 (1). Other properties of calcium phosphates such as grain size, density, strength, and resorption rates are dependent upon certain process parameters (2-9).
1.3 This specification excludes tribasic calcium phosphate, whitlockite, alpha-tricalcium phosphate, and hydro-xyapatite.
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/F1088-87R92E01
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