ASTM F2393-12(2020)

Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications

SCOPE
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.

General Information

• Status: Published
• Publication Date: 31-Jul-2020
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.13 - Ceramic Materials

Relations

• Replaces: ASTM F2393-12(2016) - Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
• Effective Date: 01-Aug-2020
• Refers: ASTM C1198-20 - Standard Test Method for Dynamic Young’s Modulus, Shear Modulus, and Poisson’s Ratio for Advanced Ceramics by Sonic Resonance
• Effective Date: 01-Jan-2020
• Refers: ASTM C1327-15(2019) - Standard Test Method for Vickers Indentation Hardness of Advanced Ceramics
• Effective Date: 01-Jul-2019
• Refers: ASTM C1239-13(2018) - Standard Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution Parameters for Advanced Ceramics
• Effective Date: 01-Jul-2018
• Refers: ASTM C373-17 - Standard 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
• Effective Date: 01-Sep-2017
• Refers: ASTM C373-16 - Standard 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
• Effective Date: 01-Aug-2016
• Refers: ASTM C373-16e1 - Standard 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
• Effective Date: 01-Aug-2016
• Refers: ASTM C1327-15 - Standard Test Method for Vickers Indentation Hardness of Advanced Ceramics
• Effective Date: 01-Jan-2015
• Refers: ASTM C373-14a - Standard Test Method for Water Absorption, Bulk Density, Apparent Porosity, and Apparent Specific Gravity of Fired Whiteware Products, Ceramic Tiles, and Glass Tiles
• Effective Date: 01-Dec-2014
• Refers: ASTM C373-14 - Standard Test Method for Water Absorption, Bulk Density, Apparent Porosity, and Apparent Specific Gravity of Fired Whiteware Products, Ceramic Tiles, and Glass Tiles
• Effective Date: 01-Mar-2014
• Refers: ASTM C1259-14 - Standard Test Method for Dynamic Young’s Modulus, Shear Modulus, and Poisson’s Ratio for Advanced Ceramics by Impulse Excitation of Vibration
• Effective Date: 01-Jan-2014
• Refers: ASTM C1198-09(2013) - Standard Test Method for Dynamic Young's Modulus, Shear Modulus, and Poisson's Ratio for Advanced Ceramics by Sonic Resonance
• Effective Date: 01-Aug-2013
• Refers: ASTM C1161-13 - Standard Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature
• Effective Date: 01-Aug-2013
• Refers: ASTM C1239-13 - Standard Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution Parameters for Advanced Ceramics
• Effective Date: 01-Aug-2013
• Refers: ASTM E112-12 - Standard Test Methods for Determining Average Grain Size
• Effective Date: 15-Nov-2012

Standards Content (Sample)

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.
Designation: F2393 −12 (Reapproved 2020)
Standard Specification for
High-Purity Dense Magnesia Partially Stabilized Zirconia
(Mg-PSZ) for Surgical Implant Applications
This standard is issued under the fixed designation F2393; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope C1239 Practice for Reporting Uniaxial Strength Data and
Estimating Weibull Distribution Parameters forAdvanced
1.1 This specification covers material requirements for
Ceramics
high-purity, dense zirconium oxide partially stabilized by
C1259 Test Method for Dynamic Young’s Modulus, Shear
magnesium oxide (magnesia partially stabilized zirconia (Mg-
Modulus, and Poisson’s Ratio for Advanced Ceramics by
PSZ)) for surgical implant applications.
Impulse Excitation of Vibration
1.2 The values stated in SI units are to be regarded as
C1327 Test Method for Vickers Indentation Hardness of
standard. No other units of measurement are included in this
Advanced Ceramics
standard.
E112 Test Methods for Determining Average Grain Size
1.3 This standard does not purport to address all of the 2.2 American Society for Quality Standard (ASQ):
safety concerns, if any, associated with its use. It is the
C1 Specification of General Requirements for a Quality
responsibility of the user of this standard to establish appro- Program
priate safety, health, and environmental practices and deter-
2.3 ISO Standard:
mine the applicability of regulatory limitations prior to use. ISO 18754 Fine Ceramics (Advanced Ceramics, Advanced
1.4 This international standard was developed in accor-
Technical Ceramics)—Determination of Density and Ap-
dance with internationally recognized principles on standard- parent Porosity
ization established in the Decision on Principles for the
3. Chemical Requirements
Development of International Standards, Guides and Recom-
3.1 Thechemicalcompositionshallbeasfollows,measured
mendations issued by the World Trade Organization Technical
by ICP-ES, XRF, or mass spectroscopy:
Barriers to Trade (TBT) Committee.
Oxides Weight percent
2. Referenced Documents
ZrO +HfO + MgO $99.8
2 2
2.1 ASTM Standards:
MgO 3.1-3.4
HfO #2.0
C373 Test Methods for Determination of Water Absorption 2
andAssociated Properties by Vacuum Method for Pressed
Total Other Oxides <0.20
Ceramic Tiles and Glass Tiles and Boil Method for
Other Oxides
Extruded Ceramic Tiles and Non-tile Fired Ceramic
Fe O <0.01
2 3
Whiteware Products
SiO <0.05
C1161 Test Method for Flexural Strength of Advanced
CaO <0.02
Al O <0.05
Ceramics at Ambient Temperature 2 3
C1198 Test Method for Dynamic Young’s Modulus, Shear NOTE 1—The radioactivity, defined as the sum of the massic activity of
U238, Ra226, Th232, and determined by γ-spectroscopy on the ready-to-
Modulus, and Poisson’s Ratio for Advanced Ceramics by
use powder, should be less than 200 Bq/Kg.
Sonic Resonance
4. Physical Requirements
4.1 The minimum bulk density of magnesia partially stabi-
This specification is under the jurisdiction of ASTM Committee F04 on
lized zirconia shall be 5.800 g/cm as determined by Test
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.13 on Ceramic Materials.
Method C373 as supplied, with the following modifications or
Current edition approved Aug. 1, 2020. Published August 2020. Originally
by ISO 18754.
approved in 2004. Last previous edition approved in 2016 as F2393 – 12 (2016).
DOI: 10.1520/F2393-12R20.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Milwaukee, WI 53203, http://www.asq.org.
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2393 − 12 (2020)
4.1.1 Weight determination per sections 3.1 and 5.1 of Test
M = monoclinic phase,
MethodC373andsection7.1ofISO18754shallbemadesuch
T = tetragonal phase, and
thatitcanbecalculatedandreportedtofoursignificantfigures.
C = cubic phase.
4.1.2 The calculation of bulk density in section 12.1 of Test
4.4 Grain size shall be determined and reported using Test
Method C373 or section 7.2 of ISO 18754 shall be as follows,
Methods E112.
to the second decimal place:
m
1 5. Mechanical Properties
ρ 5 3ρ (1)
b 1
m 2 m
3 2
5.1 The average room temperature flexural strength shall be
where:
600 MPa (87 000 psi) or greater by 4 point bend testing in
ρ = the bulk density, expressed in kilograms per cubic accordance with Test Method C1161, test configuration
...