ASTM F1873-98

Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications (Withdrawn 2007)

SCOPE
1.1 This specification covers material requirements for high-purity dense yttria tetragonal zirconium oxide polycrystal (Y-TZP) for surgical implant applications.  
1.2 The values stated in SI units are to be regarded as the standard.
WITHDRAWN RATIONALE
This specification covers material requirements for high-purity dense yttria tetragonal zirconium oxide polycrystal (Y-TZP) for surgical implant applications.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in January 2007 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

• Status: Withdrawn
• Publication Date: 09-Jun-1998
• Withdrawal Date: 07-Feb-2007
• 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

• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-Jun-1998

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F 1873 – 98
Standard Specification for
High-Purity Dense Yttria Tetragonal Zirconium Oxide
Polycrystal (Y-TZP) for Surgical Implant Applications
This standard is issued under the fixed designation F 1873; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3. Chemical Composition
1.1 This specification covers material requirements for 3.1 Thechemicalcompositionshallbeasfollows,measured
high-purity dense yttria tetragonal zirconium oxide polycrystal by X-ray fluorescence (XRF) or mass spectroscopy:
(Y-TZP) for surgical implant applications.
Weight %
ZrO HfO +Y O $ 99
2 2 2 3
1.2 The values stated in SI units are to be regarded as the
Y O 4.5to5.4
2 3
standard.
HfO # 5
Al O # 0.5
2 3
2. Referenced Documents
Other Total Oxides # 0.5
2.1 ASTM Standards:
C 373 Test Method for Water Absorption, Bulk Density,
TiO
SiO
Apparent Porosity, andApparent Specific Gravity of Fired 2
CaO
Whiteware Products
Fe O
2 3
C 1161 Test Method for Flexural Strength of Advanced
Na O
K O
Ceramics at Ambient Temperature
C 1198 Test Method for Dynamic Young’s Modulus, Shear
NOTE 1—The radioactivity, defined as the sum of the massic activity of
238 226 232
U ,Ra ,Th and determined by g-spectroscopy on the ready to use
Modulus, and Poisson’s Ratio for Advanced Ceramics by
powder, should be less than 200 Bq/kg. This value will be reviewed at the
Sonic Resonance
next revision of this standard and will be based upon the radioactivity data
C 1239 Practice for Reporting Uniaxial Strength Data and
from ceramic implant manufacturers.
Estimating Weibull Distribution Parameters for Advanced
Ceramics
4. Physical Properties
C 1259 Test Method for Dynamic Young’s Modulus, Shear
4.1 The minimum bulk density of yttrium oxide stabilized
Modulus, and Poisson’s Ratio for Advanced Ceramic by
zirconium oxide shall be 6.00 g/cm or greater as determined
Impulse Excitation of Vibration
by Test Method C 373 as applied with the following modifi-
C 1327 Test Method for Vickers Identation Hardness of
cations:
Advanced Ceramics
4.1.1 Weight determination in 3.1 and 5.1 of Test Method
E 112 Test Method for Determining Average Grain Size
C 373 shall be made to the nearest 0.5 mg.
F 748 Practice for Selecting Generic Biological Test Meth-
4.1.2 The calculation of bulk density in 12.1 ofTest Method
ods for Materials and Devices
C 373 shall be calculated as follows:
F 981 Practice for Assessment of Compatibility of Bioma-
B5~D•d!/M2S! (1)
terials for Surgical Implants with respect to Effects of
Materials on Muscle and Bone
where:
2.2 American Society for Quality Control Document: 3
B 5 bulk density, g/cm ,
C 1 Specification of General Requirements for a Quality
D 5 dry weight, g,
Program
M 5 saturated weight, g,
S 5 suspended weight, g, and
ThisspecificationisunderthejurisdictionofASTMCommitteeF-4onMedical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.13 on Ceramic Materials.
Current edition approved June 10, 1998. Published August 1998.
Annual Book of ASTM Standards, Vol 15.02.
Annual Book of ASTM Standards, Vol 15.01.
4 6
Annual Book of ASTM Standards, Vol 03.01. Available from theAmerican National Standards Institute, 11W. 42nd St., 13th
Annual Book of ASTM Standards, Vol 13.01. Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 1873
applications, the manufacturer and end user may agree that
d 5 densityofwateratthetemperaturewhenmeasurement
Weibull modulus testing is mandatory. If Weibull modulus is
is taken.
tested it shall be tested in accordance with Practice C 1239.
4.2 The total porosity shall be no greater than 1.0 vol % and
The minimum number of specimens tested shall be 30 and the
open porosity shall be no greater than 0.1 vol % as determined
minimum acceptable Weibull modulus shall be 10.
by Test Method C 373.
4.3 Grain Size—The mean linear intercept distance shall be 5.3 The minimum room temperature elastic modulus shall
0.6 µm or less, in accordance with Section 10 of Test Method be 200 GPa (29310 psi) in accordance with Test Method
E 112. C 1198.Arectangular specimen with dimensions of 60 mm by
4.4 The monoclinic phase shall be 5 % or less on a polished 10 by 3 mm is recommended. An acceptable alternative test
surface with surface finish equivalent to 0.05 µm Ra (0.8 µm method for elastic modulus is Test Method C 1259.
cutoff). Peak height of tetragonal phase, T(111) at 2u530.2°,
5.4 The minimum Vickers hardness value shall be 1200 HV
and monoclinic phase, M(1¯11) at 2u528.2° and M(111) at
in accordance withTest Method C 1327.The load shall be 1 kg
2u531.3° shall be identified by X-ray diffraction (Copper K
and the dwell time shall be 15 s.
Alpha radiation)
...