ASTM F2393-10

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.

General Information

• Status: Historical
• Publication Date: 31-Aug-2010
• 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 F2393-04 - Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
• Effective Date: 01-Sep-2010
• Replaced By: ASTM F2393-12 - Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
• Effective Date: 01-Mar-2012
• Referred By: ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
• Effective Date: 01-Sep-2010

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2393 – 10
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 C1327 Test Method for Vickers Indentation Hardness of
Advanced Ceramics
1.1 This specification covers material requirements for
E112 Test Methods for Determining Average Grain Size
high-purity, dense zirconium oxide partially stabilized by
2.2 American Society for Quality Standard (ASQ):
magnesium oxide (magnesia partially stabilized zirconia (Mg-
C1 Specification of General Requirements for a Quality
PSZ)) for surgical implant applications.
3
Program
1.2 The values stated in SI units are to be regarded as
2.3 ISO Standard:
standard. No other units of measurement are included in this
ISO 18754 Fine Ceramics (Advanced Ceramics, Advanced
standard.
Technical Ceramics)—Determination of Density and Ap-
1.3 This standard does not purport to address all of the
4
parent Porosity
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3. Chemical Requirements
priate safety and health practices and determine the applica-
3.1 Thechemicalcompositionshallbeasfollows,measured
bility of regulatory requirements prior to use.
by ICP-ES, XRF, or mass spectroscopy:
2. Referenced Documents
Oxides Weight percent
2
2.1 ASTM Standards:
ZrO +HfO + MgO $99.8
2 2
C373 Test Method for Water Absorption, Bulk Density,
MgO 3.1-3.4
HfO #2.0
2
Apparent Porosity, andApparent Specific Gravity of Fired
Whiteware Products
Total Other Oxides <0.20
C1161 Test Method for Flexural Strength of Advanced
Other Oxides
Ceramics at Ambient Temperature
Fe O <0.01
2 3
C1198 Test Method for Dynamic Young’s Modulus, Shear
SiO <0.05
2
Modulus, and Poisson’s Ratio for Advanced Ceramics by CaO <0.02
Al O <0.05
2 3
Sonic Resonance
C1239 Practice for Reporting Uniaxial Strength Data and
NOTE 1—The radioactivity, defined as the sum of the massic activity of
Estimating Weibull Distribution Parameters for Advanced U238, Ra226, Th232, and determined by g-spectroscopy on the ready-to-
use powder, should be less than 200 Bq/Kg.
Ceramics
C1259 Test Method for Dynamic Young’s Modulus, Shear
4. Physical Requirements
Modulus, and Poisson’s Ratio for Advanced Ceramics by
4.1 The minimum bulk density of magnesia partially stabi-
Impulse Excitation of Vibration
3
lized zirconia shall be 5.800 g/cm as determined by Test
Method C373 as supplied, with the following modifications or
by ISO 18754.
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.1.1 Weight determination per sections 3.1 and 5.1 of Test
Medical and Surgical Materials and Devices and is the direct responsibility of
MethodC373andsection7.1ofISO 18754shallbemadesuch
Subcommittee F04.13 on Ceramic Materials.
thatitcanbecalculatedandreportedtofoursignificantfigures.
Current edition approved Sept. 1, 2010. Published September 2010. Originally
approved in 2004. Last previous edition approved in 2004 as F2393 – 04. DOI:
10.1520/F2393-10.
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.
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 – 10
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.
4.4 Grain size shall be determined and reported using Test
m
1
r 5 3r (1)
b 1
Method E112.
m – m
3 2
5. Mechanical Properties
where:
r = the bulk density, expressed in kilograms per cubic
5.1 The average room temperature flexural strength shall be
b
metre,
600 MPa (87 000 psi) or greater by 4 point bend testing in
m = the mass of the dry test specimen, expressed in
accordance with Test Method C1161, test configuration B. A
1
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 considered
...

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:F2393–04 Designation: F2393 – 10
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
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
C1145Terminology of Advanced Ceramics
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
F748Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone 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-AAS,ICP-ES, XRF, or mass spectroscopy:
Weight percent
Oxides Weight percent
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 May 1, 2004. Published June 2004. DOI: 10.1520/F2393-04.
Current edition approved Sept. 1, 2010. Published September 2010. Originally approved in 2004. Last previous edition approved in 2004 as F2393 – 04. DOI:
10.1520/F2393-10.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. 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.
4
Garvie, Ronald C., and Nicholson, Patrick F., “Phase Analysis in Zirconia Systems,” Journal of the American Ceramic Society, 55, [6], 1972, pp. 303-305.
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 – 10
ZrO + $99.9
2
HfO +
2
MgO
ZrO + $99.8
2
HfO +
2
MgO
MgO 3.1-3.4
HfO #2.0
2
Other
Oxides
Total <0.20
Other
Oxides
Total <0.1
<0.1
Al
Other
Oxides
Fe O <0.05 <0.01
2 3
Fe O <0.01
2 3
SiO <0.05
2
CaO <0.02
Fe O <0.002
2 3
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 5.8205.800 g/cm or greater as determined by
Test Method C373 as supplied with the following modifications.
4.1
...