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ASTM F1537-00

(Specification)

Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

SCOPE
1.1 This specification covers the material requirements of wrought cobalt-28-chromium-6-molybdenum alloy used for surgical implants. Material conforming to this specification has been evaluated for biocompatibility and corrosion resistance and has been found to be comparable to material conforming to Specification F75. The properties specified in this specification apply specifically to wrought bar product.  
1.2 The values stated in inch-pound units are to be regarded as the standard. The metric equivalents of the inch-pound units may be approximate.

General Information

Status
Historical
Publication Date
09-May-2000
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 F1537-07 - Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
Effective Date
01-Jul-2007
Referred By
ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
Effective Date
10-May-2000
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
10-May-2000
Referred By
ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
Effective Date
10-May-2000
Referred By
ASTM F1377-21 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
Effective Date
10-May-2000
Referred By
ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
Effective Date
10-May-2000
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
10-May-2000
Referred By
ASTM F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
Effective Date
10-May-2000
Referred By
ASTM F2527-16 - Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)
Effective Date
10-May-2000
Referred By
ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
10-May-2000
Referred By
ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
Effective Date
10-May-2000
Referred By
ASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
Effective Date
10-May-2000
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
10-May-2000
Referred By
ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
Effective Date
10-May-2000
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
10-May-2000

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ASTM F1537-00 - Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)ASTM F1537-00 - Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
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Technical specification
ASTM F1537-00 - Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
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3 pages
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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 1537 – 00
Standard Specification for
Wrought Cobalt - 28Chromium - 6Molybdenum Alloys for
Surgical Implants (UNS R31537, UNS R31538, and UNS
R31539)
This standard is issued under the fixed designation F 1537; 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 three 3.1 The purpose of this specification is to characterize the
wrought cobalt - 28chromium - 6molybdenum alloys used for chemical, mechanical, and metallurgical requirements of
surgical implants.The properties specified apply specifically to wrought cobalt - 28chromium - 6 molybdenum bar, rod, and
wrought bar, rod, and wire. wire.
1.2 The values stated in inch-pound units are to be regarded
4. Ordering Information
asthestandard.TheSIequivalentsoftheinch-poundunitsmay
be approximate. 4.1 Inquiries and orders for material under this specification
shall include the following information:
2. Referenced Documents
4.1.1 Quantity,
2.1 ASTM Standards: 4.1.2 ASTM designation and alloy number,
E 8 Test Methods forTensionTesting of Metallic Materials 4.1.3 Mechanical properties (See Section 7),
E 18 Test Methods for Rockwell Hardness and Rockwell 4.1.4 Form (bar, rod or wire),
Superficial Hardness of Metallic Materials 4.1.5 Applicable dimensions including size, thickness,
E 112 Test Methods for Determining Average Grain Size width, and length (exact, random, or multiples) or drawing
E 354 Test Methods for Chemical Analysis of High Tem- number,
perature, Electrical, Magnetic, and Other Similar Iron, 4.1.6 Condition (See Section5,
Nickel, and Cobalt Alloys 4.1.7 Special tests (if any), and
F 75 Specification for Cast Cobalt-Chromium Molybdenum 4.1.8 Other requirements.
Alloy for Surgical Implant Applications
5. Condition
2.2 Aerospace Material Specifications:
AMS 2269 Chemical Check Analysis Limits, Nickel, 5.1 Product shall be furnished as specified below:
5.1.1 The annealed condition is typically supplied as a hot
Nickel Alloys and Cobalt Alloys
AMS 2248 Chemical Check Analysis Limits, Corrosion rolled and annealed product.
5.1.2 Thehotworkedconditionistypicallysuppliedasahot
and Heat Resistant Steels andAlloys, Maraging and Other
Highly-Alloyed Steels, and Iron Alloys rolled and unannealed product.
5.1.3 The warm worked condition is typically supplied as a
AMS 2630 Ultrasonic Inspection
2.3 American Society for Quality Standard: thermomechanically processed product to achieve a strainhard-
ened structure.
ASQ C1 Specification of General Requirements for a Qual-
ity Program 5.1.4 Other conditions may be provided as agreed upon
between purchaser and supplier.
This specification is under the jurisdiction of ASTM Committee F04 on 6. Chemical Requirements
Medical and Surgical Materials and Devices and is the direct responsibility of
6.1 Thecobalt-28chromium-6molybdenumalloysshallcon-
Subcommittee F04.12 on Metallurgical Materials.
form to the chemical requirements prescribed in Table 1. The
Current edition approved May 10, 2000. Published August 2000. Originally
published as F 1537 – 94. Last previous edition F 1537 – 94.
supplier shall not ship material that is outside the limits
Annual Book of ASTM Standards, Vol 03.01.
specified in Table 1 for the applicable alloy.
Annual Book of ASTM Standards, Vol 03.05.
4 6.1.1 Requirements for the major and minor elemental
Annual Book of ASTM Standards, Vol 13.01.
constituents are listed in Table 1. Also listed are important
Available from Society of Automotive Engineers, Inc., 400 Commonwealth
Drive, Warrendale, PA 15096-0001.
residual elements.Analysis for elements not listed inTable 1 is
Available from American Society for Quality, 611 East Wisconsin Avenue,
not required to verify compliance with this specification.
Milwaukee, WI 53203.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 1537
TABLE 1 Chemical Composition
7. Mechanical Requirements
Composition % (mass/mass)
7.1 Tensile Properties:
Element Alloy 1 Alloy 2 Alloy 3
7.1.1 Tensile properties shall be determined in accordance
UNS R31537 UNS R31538 UNS R31539
with Test Methods E 8
(Low Carbon) (High Carbon) (Dispersion
7.1.2 The mechanical properties of test specimens shall
Strengthened)
conform to the requirements specified in Table 3.
min max min max min max
Carbon . 0.14 0.15 0.35 . 0.14 7.2 Hardness:
Aluminum . . . . 0.30 1.00
7.2.1 Hardness values shall be determined in accordance
Lanthanum . . . . 0.03 0.20
with Test Methods E 18.
Chromium 26.0 30.0 26.0 30.0 26.0 30.0
Molybdenum 5.0 7.0 5.0 7.0 5.0 7.0
7.2.2 Hardness values are for information only and shall not
Nickel . 1.0 . 1.0 . 1.0
be used as a basis for rejection.
Iron . 0.75 . 0.75 . 0.75
Silicon . 1.0 . 1.0 . 1.0
8. Special Tests
Manganese . 1.0 . 1.0 . 1.0
Nitrogen . 0.25 . 0.25 . 0.25
8.1 Bar, rod, and wire conforming to this specification shall
A
Cobalt Balance Balance Balance
have a homogeneous microstructure with an average grain size
A
Approximately equal to the difference of 100 % and the sum percentage of the
of ASTM No. 5 or finer when measured in accordance with
other specified elements.The percentage of cobalt difference is not required to be
Test Methods E 112.
reported.
8.2 Ultrasonic inspection should
...

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