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ASTM F1377-98a

(Specification)

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS-R30075)

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS-R30075)

SCOPE
1.1 This specification covers the requirements for cobalt-chromium-molybdenum alloy powders for use in fabricating coatings on cobalt-chromium-molybdenum alloy orthopedic implants.
1.2 Powders covered under this specification may be used to form coatings by sintering or plasma 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 the standard. The SI units given in parentheses are for information only.

General Information

Status
Historical
Publication Date
09-Apr-1998
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.12 - Metallurgical Materials
Current Stage
Ref Project

Relations

Replaced By
ASTM F1377-04 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
Effective Date
01-Oct-2004
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
10-Apr-1998
Referred By
ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
Effective Date
10-Apr-1998
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
10-Apr-1998
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
10-Apr-1998
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
10-Apr-1998

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ASTM F1377-98a - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS-R30075)ASTM F1377-98a - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS-R30075)
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ASTM F1377-98a - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS-R30075)
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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 1377 – 98a
Standard Specification for
Cobalt-28 Chromium-6 Molybdenum Powder for Coating of
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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3. Significance and Use
1.1 This specification covers the requirements for cobalt-28 3.1 Coatings formed from metallic powders have become
chromium-6 molybdenum alloy powders for use in fabricating widely used as a means of improving tissue attachment to
coatings on cobalt-28 chromium-6 molybdenum alloy ortho- uncemented orthopedic joint prosthesis. Such coatings have
pedic implants. also been demonstrated to improve bonding of acrylic cement
1.2 Powders covered under this specification may be used to to prostheses. This specification addresses the special require-
form coatings by sintering or thermal spraying techniques. ments of the metal powders used to form these coatings.
1.3 This specification covers powder requirements only. It
4. Materials and Manufacture
does not address properties of the coatings formed from them.
1.4 The values stated in inch-pound units are to be regarded 4.1 Powders may be manufactured by the rotating electrode
process, inert gas atomization, or other methods capable of
as the standard. The SI units given in parentheses are for
information only. producing powder meeting the requirements of this specifica-
tion.
2. Referenced Documents
5. Chemical Composition
2.1 ASTM Standards:
5.1 The heat analysis of stock used to manufacture the
B 214 Test Method for Sieve Analysis of Metal Powders
B 215 Practices for Sampling Finished Lots of Metal Pow- powder shall conform to the chemical analysis set forth in
Table 1 of Specification F 75.
ders
E 11 Specification for Wire-Cloth Sieves for Testing Pur- 5.2 The product analysis tolerance shall conform to the
poses requirements set forth in Table 2 of Specification F 75.
5.3 For referee purposes, Test Methods E 354 shall be used.
E 354 Test Methods for Chemical Analysis of High Tem-
perature, Electrical, Magnetic, and Other Similar Iron,
4 6. Particle Size
Nickel, and Cobalt Alloys
6.1 Powder shall be sieved to the customer’s requirements
F 75 Specification for Cobalt-28 Chromium-6 Molybdenum
with screens conforming to Specification E 11. Analysis of the
Casting Alloy and Cast Products for Surgical Implants
sieved powder for conformance to customer’s particle size
(UNS-R30075)
range requirements shall be according to Test Method B 214.
F 981 Practice for Assessment of Compatibility of Bioma-
Powder sampling shall be according to Test Method B 215.
terials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone
7. Cleanliness
2.2 ASQ Standards:
7.1 Powder shall be handled at all times so as to minimize
C1 General Requirements for a Quality Program
possible contamination with nonmetallic materials or other
metal alloy powders, or both.
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
7.2 Powder cleanliness shall be determined by examining a
and Surgical Materials and Devicesand is the direct responsibility of Subcommittee 2 2
representative sample comprising at least 1 in. (645 mm )of
F04.12on Metallurgical Materials.
a closely packed mono-layer of powder at 203 magnification.
Current edition approved April 10, 1998. Published March 1999. Originally
published as F 1377–92. Last previous edition F 1377–98. No foreign material shall be visible under these conditions.
Annual Book of ASTM Standards, Vol 02.05.
Annual Book of ASTM Standards, Vol 14.02.
Annual Book of ASTM Standards, Vol 03.05.
Annual Book of ASTM Standards, Vol 13.01.
Available from American Society for Quality, 611 East Wisconsin Ave.,
Milwaukee, WI 53203.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 1377
8. Special Requirements 9.1.5 Sieve analysis in accordance with 6.1,
9.1.6 Powder cleanliness in accordance with 7.2,
8.1 Various materials known as processing aids may be
9.1.7 Special requirements in accordance with 8.1, and
added to the powder to provide enhanced processability and, if
9.1.8 Other requirements.
applicable, th
...

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