ASTM F1088-04

Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

STANDARD published on 1.1.2004

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The information about the standard:

Designation standards: ASTM F1088-04
Note: WITHDRAWN
Publication date standards: 1.1.2004
SKU: NS-49086
The number of pages: 2
Approximate weight : 6 g (0.01 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM F1088-04 :

Keywords:

advanced ceramics, -TCP, -tricalcium phosphate, calcium phosphate material, ceramic, surgical implant

Additional information

1. Scope

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.

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

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