ASTM F2393-04

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 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: 30-Apr-2004
• 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

• Replaced By: ASTM F2393-10 - Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
• Effective Date: 01-Sep-2010
• Referred By: ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
• Effective Date: 01-May-2004

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 – 04
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 rials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone
1.1 This specification covers material requirements for
2.2 American Society for Quality Standard (ASQ):
high-purity, dense zirconium oxide partially stabilized by
C1 Specification of General Requirements for a Quality
magnesium oxide (magnesia partially stabilized zirconia (Mg-
Program
PSZ)) for surgical implant applications.
1.2 This standard does not purport to address all of the
3. Chemical Requirements
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-AAS, XRF, or mass spectroscopy:
priate safety and health practices and determine the applica-
Weight percent
bility of regulatory requirements prior to use.
ZrO +HfO + MgO $99.9
2 2
2. Referenced Documents
MgO 3.1-3.4
HfO #2.0
2.1 ASTM Standards: 2
C373 Test Method for Water Absorption, Bulk Density,
Other Oxides
Apparent Porosity, andApparent Specific Gravity of Fired
Total <0.1
Whiteware Products
Al O <0.05
2 3
C1145 Terminology of Advanced Ceramics
SiO <0.05
C1161 Test Method for Flexural Strength of Advanced CaO <0.02
Fe O <0.002
2 3
Ceramics at Ambient Temperature
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 g-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
C1239 Practice for Reporting Uniaxial Strength Data and
4. Physical Requirements
Estimating Weibull Distribution Parameters for Advanced
4.1 The minimum bulk density of magnesia partially stabi-
Ceramics
lized zirconia shall be 5.820 g/cm or greater as determined by
C1259 Test Method for Dynamic Young’s Modulus, Shear
Test Method C373 as supplied with the following modifica-
Modulus, and Poisson’s Ratio for Advanced Ceramics by
tions.
Impulse Excitation of Vibration
4.1.1 Weight determination in sections 3.1 and 5.1 of Test
C1327 Test Method for Vickers Indentation Hardness of
Method C373 shall be made such that it can be calculated and
Advanced Ceramics
reported to four significant figures.
E112 Test Methods for Determining Average Grain Size
4.1.2 The calculation of bulk density in section 12.1 of Test
F748 Practice for Selecting Generic Biological Test Meth-
Method C373 shall be calculated as follows:
ods for Materials and Devices
F981 Practice forAssessment of Compatibility of Biomate- B 5 ~D2d!/~M2S! (1)
where:
B = bulk density, g/cm ,
This specification is under the jurisdiction of ASTM Committee F04 on
D = dry weight, g,
Medical and Surgical Materials and Devices and is the direct responsibility of
M = saturated weight, g,
Subcommittee F04.13 on Ceramic Materials.
S = suspended weight, g, and
Current edition approved May 1, 2004. Published June 2004. DOI: 10.1520/
F2393-04.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
the ASTM website. Milwaukee, WI 53203.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F2393 – 04
accordance with Test Method C1161, test configuration B. A
d = densityofwateratthetemperaturewhenmeasurement
minimum of 10 samples are to be tested.
is made.
5.2 Weibull modulus value is not considered mandatory for
4.2 The total porosity shall be no greater than 1.0 vol % and
general acceptance and use of this material. It shall be
open porosity shall be no greater than 0.1 vol % as determined
performed when changing suppliers or when the material is
by Test Method C373.
produced via a different process. For certain applicat
...