ASTM F2393-12
(Specification)Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
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 and health practices and determine the applicability of regulatory requirements prior to use.
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Designation: F2393 −12
StandardSpecification for
High-Purity Dense Magnesia Partially Stabilized Zirconia
1
(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 E112 Test Methods for Determining Average Grain Size
2.2 American Society for Quality Standard (ASQ):
1.1 This specification covers material requirements for
C1 Specification of General Requirements for a Quality
high-purity, dense zirconium oxide partially stabilized by
3
Program
magnesium oxide (magnesia partially stabilized zirconia (Mg-
2.3 ISO Standard:
PSZ)) for surgical implant applications.
ISO 18754 Fine Ceramics (Advanced Ceramics, Advanced
1.2 The values stated in SI units are to be regarded as
Technical Ceramics)—Determination of Density and Ap-
4
standard. No other units of measurement are included in this
parent Porosity
standard.
3. Chemical Requirements
1.3 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
3.1 Thechemicalcompositionshallbeasfollows,measured
responsibility of the user of this standard to establish appro-
by ICP-ES, XRF, or mass spectroscopy:
priate safety and health practices and determine the applica-
Oxides Weight percent
bility of regulatory requirements prior to use.
ZrO +HfO + MgO $99.8
2 2
MgO 3.1-3.4
2. Referenced Documents
HfO #2.0
2
2
2.1 ASTM Standards:
Total Other Oxides <0.20
C373 Test Method for Water Absorption, Bulk Density,
Apparent Porosity, andApparent Specific Gravity of Fired
Other Oxides
Fe O <0.01
2 3
Whiteware Products
SiO <0.05
2
C1161 Test Method for Flexural Strength of Advanced
CaO <0.02
Ceramics at Ambient Temperature
Al O <0.05
2 3
C1198 Test Method for Dynamic Young’s Modulus, Shear
NOTE 1—The radioactivity, defined as the sum of the massic activity of
Modulus, and Poisson’s Ratio for Advanced Ceramics by
U238, Ra226, Th232, and determined by γ-spectroscopy on the ready-to-
Sonic Resonance use powder, should be less than 200 Bq/Kg.
C1239 Practice for Reporting Uniaxial Strength Data and
4. Physical Requirements
Estimating Weibull Distribution Parameters forAdvanced
Ceramics 4.1 The minimum bulk density of magnesia partially stabi-
3
lized zirconia shall be 5.800 g/cm as determined by Test
C1259 Test Method for Dynamic Young’s Modulus, Shear
Method C373 as supplied, with the following modifications or
Modulus, and Poisson’s Ratio for Advanced Ceramics by
by ISO 18754.
Impulse Excitation of Vibration
4.1.1 Weight determination per sections 3.1 and 5.1 of Test
C1327 Test Method for Vickers Indentation Hardness of
MethodC373andsection7.1ofISO18754shallbemadesuch
Advanced Ceramics
thatitcanbecalculatedandreportedtofoursignificantfigures.
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of
Subcommittee F04.13 on Ceramic Materials.
Current edition approved March 1, 2012. Published March 2012. Originally
approved in 2004. Last previous edition approved in 2010 as F2393 – 10. DOI:
10.1520/F2393-12.
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 service@astm.org. For Annual Book of ASTM Milwaukee, WI 53203, http://www.asq.org.
4
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
1
---------------------- Page: 1 ----------------------
F2393 − 12
4.1.2 The calculation of bulk density in section 12.1 of Test
M = monoclinic phase,
Method C373 or section 7.2 of ISO 18754 shall be as follows,
T = tetragonal phase, and
to the second decimal place:
C = cubic phase.
m
4.4 Grain size shall be determined and reported using Test
1
ρ 5 3ρ (1)
b 1
m 2 m
Method E112.
3 2
where:
5. Mechanical Properties
ρ = the bulk density, expressed in kilograms per cubic
b
5.1 The average room temperature flexural strength shall be
metre,
600 MPa (87 000 psi) or greater by 4 point bend testing in
m = the mass of the dry test specimen, expressed in
1
accordance with Test Method C1161, test configuration B. A
kilograms,
minimum of 10 samples are to be tested.
m = the apparent mass of the immersed test speciment,
2
5.2 Weibull modulus value is not
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F2393–10 Designation: F2393 – 12
Standard Specification for
High-Purity Dense Magnesia Partially Stabilized Zirconia
1
(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
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 and health practices and determine the applicability of regulatory
requirements prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
C373 Test Method for WaterAbsorption, Bulk Density,Apparent Porosity, andApparent Specific Gravity of Fired Whiteware
Products
C1161 Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature
C1198 Test Method for Dynamic Young’s Modulus, Shear Modulus, and Poisson’s Ratio for Advanced Ceramics by Sonic
Resonance
C1239 Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution Parameters forAdvanced Ceramics
C1259 Test Method for Dynamic Young’s Modulus, Shear Modulus, and Poisson’s 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
2.2 American Society for Quality Standard (ASQ):
3
C1 Specification of General Requirements for a Quality Program
2.3 ISO Standard:
ISO 18754 Fine Ceramics (Advanced Ceramics, Advanced Technical Ceramics)—Determination of Density and Apparent
4
Porosity
3. Chemical Requirements
3.1 The chemical composition shall be as follows, measured by ICP-ES, XRF, or mass spectroscopy:
Oxides Weight percent
ZrO +HfO + MgO $99.8
2 2
MgO 3.1-3.4
HfO #2.0
2
Total Other Oxides <0.20
Other Oxides
Fe O <0.01
2 3
SiO <0.05
2
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.13 on Ceramic Materials.
Current edition approved Sept.March 1, 2010.2012. Published September 2010.March 2012. Originally approved in 2004. Last previous edition approved in 20042010
as F2393 – 104. DOI: 10.1520/F2393-102.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book ofASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 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.
1
---------------------- Page: 1 ----------------------
F2393 – 12
CaO <0.02
Al O <0.05
2 3
NOTE 1—The radioactivity, defined as the sum of the massic activity of U238, Ra226, Th232, and determined by g-spectroscopy on the ready-to-use
powder, should be less than 200 Bq/Kg.
4. Physical Requirements
3
4.1 The minimum bulk density of magnesia partially stabilized zirconia shall be 5.800 g/cm as determined by Test Method
C373 as supplied, with the following modifications or by ISO 18754.
4.1.1 Weight determination per sections 3.1 and 5.1 ofTest Method C373 and section 7.1 of ISO 18754 shall be made such that
it can be calculated and reported to four significant figures.
2
---------------------- Page: 2 ----------------------
F2393 – 12
4.1.2 The calculation of bulk density in section 12.1 of Test Method C373 or section 7.2 of ISO 18754 shall be as follows, to
the second decimal place:
m
1
r 5 3r (1)
b 1
m – m
3 2
where:
r = the bulk density, expressed in kilograms per cubic metre,
b
m = the mass of the dry test specimen, expressed in kilograms,
1
m = the apparent mass of the immersed test specimen
...
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