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1.1 This specification covers material requirements for high-purity, dense zirconium oxide partially stabilized by magnesium oxide (magnesia partially stabilized zirconia (Mg-PSZ)) for surgical implant applications.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ISO StandardISO 18754 Fine Ceramics (Advanced Ceramics, Advanced Technical Ceramics)Determination of Density and Apparent Porosity Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
C373 Test Methods for Determination of Water Absorption and Associated Properties by Vacuum Method for Pressed Ceramic Tiles and Glass Tiles and Boil Method for Extruded Ceramic Tiles and Non-tile Fired Ceramic Whiteware Products
C1161 Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature
C1198 Test Method for Dynamic Youngs Modulus, Shear Modulus, and Poissons Ratio for Advanced Ceramics by Sonic Resonance
C1239 Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution Parameters for Advanced Ceramics
C1259 Test Method for Dynamic Youngs Modulus, Shear Modulus, and Poissons Ratio for Advanced Ceramics by Impulse Excitation of Vibration
C1327 Test Method for Vickers Indentation Hardness of Advanced Ceramics
E112 Test Methods for Determining Average Grain Size
American Society for Quality Standard (ASQ)C1
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)
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ASTM F2393-12(2020), Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications, ASTM International, West Conshohocken, PA, 2020, www.astm.orgBack to Top