1.1 This specification covers material requirements for biocompatible beta tricalcium phosphate (-TCP) for surgical implant applications. For a material to be called beta-tricalcium phosphate, it must conform to this specification (see Appendix X1). 1.2 Beta-tricalcium phosphate is used in medical devices which have been cleared for marketing by the U.S. Food and Drug Administration. |
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 | |
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