ASTM F1377-08
(Specification)Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
ABSTRACT
This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders for coating of orthopedic implants. This specification covers powder requirements only and does not address coating properties. Materials may be manufactured by rotating electrode process, inert gas atomization, or other methods that meet the powder requirements of this specification. The powder shall conform to chemical composition, sieve analysis, and cleanliness requirements of this specification.
SCOPE
1.1 This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders for use in fabricating coatings on cobalt-28chromium-6molybdenum alloy orthopedic implants.
1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques.
1.3 This specification covers powder requirements only. It does not address properties of the coatings formed from them.
1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
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Designation:F1377 −08
StandardSpecification for
Cobalt-28Chromium-6Molybdenum Powder for Coating of
1
Orthopedic Implants (UNS R30075)
This standard is issued under the fixed designation F1377; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
4
1. Scope* 2.3 ISO Standard:
ISO 9001Quality Management Standard
1.1 This specification covers the requirements for cobalt-
28chromium-6molybdenum alloy powders for use in fabricat-
3. Ordering Information
ingcoatingsoncobalt-28chromium-6molybdenumalloyortho-
3.1 Inquiriesandordersformaterialunderthisspecification
pedic implants.
shall include the following information:
1.2 Powderscoveredunderthisspecificationmaybeusedto
3.1.1 Quantity,
form coatings by sintering or thermal spraying techniques.
3.1.2 ASTM designation and date of issue,
1.3 This specification covers powder requirements only. It 3.1.3 Method of powder manufacturing,
does not address properties of the coatings formed from them. 3.1.4 Chemistry requirements,
3.1.5 Sieve analysis requirements,
1.4 Thevaluesstatedininch-poundunitsaretoberegarded
3.1.6 Special tests, if any, and
as standard. The values given in parentheses are mathematical
3.1.7 Other requirements.
conversions to SI units that are provided for information only
and are not considered standard.
4. Significance and Use
4.1 Coatings formed from metallic powders have become
2. Referenced Documents
widely used as a means of improving tissue attachment to
2
2.1 ASTM Standards:
uncemented orthopedic joint prosthesis. Such coatings have
B214Test Method for Sieve Analysis of Metal Powders
also been demonstrated to improve bonding of acrylic cement
B215Practices for Sampling Metal Powders
to prostheses. This specification addresses the special require-
E11Specification forWovenWireTest Sieve Cloth andTest
ments of the metal powders used to form these coatings.
Sieves
E354 Test Methods for Chemical Analysis of High-
5. Materials and Manufacture
Temperature,Electrical,Magnetic,andOtherSimilarIron,
5.1 Powders may be manufactured by the rotating electrode
Nickel, and Cobalt Alloys
process, inert gas atomization, or other methods capable of
F75Specification for Cobalt-28 Chromium-6 Molybdenum
producing powder meeting the requirements of this specifica-
Alloy Castings and Casting Alloy for Surgical Implants
tion.
(UNS R30075)
3
2.2 ASQ Standard: 6. Chemical Composition
ASQ C1General Requirements for a Quality Program
6.1 The heat analysis of stock used to manufacture the
powder shall conform to the chemical analysis set forth in
Table1 of Specification F75.
6.2 The product analysis tolerance shall conform to the
1
This specification is under the jurisdiction of ASTM Committee F04 on
requirements set forth in Table2 of Specification F75.
Medical and Surgical Materials and Devicesand is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials. 6.3 For referee purposes, Test Methods E354 shall be used.
Current edition approved Oct. 1, 2008. Published October 2008. Originally
approved in 1992. Last previous edition approved in 2004 as F1377–04. DOI:
7. Sieve Analysis Requirements
10.1520/F1377-08.
2 7.1 Powder shall be sieved to the customer’s requirements
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
with screens conforming to Specification E11. Sieve analysis
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3
4
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Milwaukee, WI 53203, http://www.asq.org. 4th Floor, New York, NY 10036, http://www.ansi.org.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1377−08
testing of the sieved powder for conformance to purchaser’s 9. Certification
particle size range requirements shall be performed according
9.1 Certification that the material meets the requirements of
to Test Method B214. Powder sampling shall be performed
the specification shall be provided by the supplier.Areport of
according to Test Method B215.
the test results shall be furnished at the time of shipment.
8. Cleanliness Requirements
10. Quality Program Requirements
8.1 Powder shall be handled at all times so as to minimize
possible contamination with nonmetallic materials or other
10.1 The powder supplier shall
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM 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:F1377–04 Designation: F 1377 – 08
Standard Specification for
Cobalt-28Chromium-6Molybdenum Powder for Coating of
1
Orthopedic Implants (UNS R30075)
This standard is issued under the fixed designation F 1377; 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 the requirements for cobalt-28chromium-6molybdenum alloy powders for use in fabricating
coatings on cobalt-28chromium-6molybdenum alloy orthopedic implants.
1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques.
1.3 This specification covers powder requirements only. It does not address properties of the coatings formed from them.
1.4The values stated in inch-pound units are to be regarded as the standard.The SI units given in parentheses are for information
only.
1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
2. Referenced Documents
2
2.1 ASTM Standards:
B 214 Test Method for Sieve Analysis of Metal Powders
B 215Practices for Sampling Finished Lots of Metal Powders Practices for Sampling Metal Powders
E 11 Specification for Wire Cloth and Sieves for Testing Purposes
E 354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and
Cobalt Alloys
F 75Specification for Cobalt-28Chromium-6Molybdenum Castings and Casting Alloy for Surgical Implants (UNS R30075)
F981Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
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
F04.12 on Metallurgical Materials.
Current edition approved Oct. 1, 2004.2008. Published October 2004.2008. Originally approved in 1992. Last previous edition approved in 19982004 as
F1377–98a.F 1377 – 04.
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.
*A Summary of Changes section appears at the end of this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F1377–08
Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
3
2.2 ASQ Standards: ASQ Standard:
C1General Requirements for a Quality Program
ASQ C1 General Requirements for a Quality Program
4
2.3 ISO Standard:
ISO 9001 Quality Management Standard
3. Ordering Information
3.1 Inquiries and orders for material under this specification shall include the following information:
3.1.1 Quantity,
3.1.2 ASTM designation and date of issue,
3.1.3 Method of powder manufacturing,
3.1.4 Chemistry requirements,
3.1.5 Sieve analysis requirements,
3.1.6 Special tests, if any, and
3.1.7 Other requirements.
4. Significance and Use
4.1 Coatingsformedfrommetallicpowdershavebecomewidelyusedasameansofimprovingtissueattachmenttouncemented
orthopedic joint prosthesis. Such coatings have also been demonstrated to improve bonding of acrylic cement to prostheses. This
specification addresses the special requirements of the metal powders used to form these coatings.
5. Materials and Manufacture
5.1 Powders may be manufactured by the rotating electrode process, inert gas atomization, or other methods capable of
producing powder meeting the requirements of this specification.
6. Chemical Composition
6.1 The heat analysis of stock used to manufacture the powder shall conform to the chemical analysis set forth in Table 1 of
Specification F 75.
6.2 The product analysis tolerance shall conform to the requirements set forth in Table 2 of Specification F 75.
6.3 For referee purposes, Test Methods E 354 shall be used.
7. Sieve Analysis Requirements
7.1 Powder shall be sieved to the customer’s requirements with screens conforming to Specification E 11. Sieve analysis testing
of the sieved powder for
...
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