ASTM F1058-97

Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008)

SCOPE
1.1 This specification covers the requirements for two grades of wrought 40cobalt-20chromium-16iron-15nickel-7molybdenum alloy in the form of wire and strip used for the manufacture of surgical implants.
1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents of the inch-pound untis may be approximate.

General Information

• Status: Historical
• Publication Date: 09-Apr-2002
• 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

Relations

• Replaced By: ASTM F1058-02 - Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008)
• Effective Date: 10-Apr-2002
• Referred By: ASTM F2180-17 - Standard Specification for Metallic Implantable Strands and Cables
• Effective Date: 10-Apr-2002
• 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-Apr-2002

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1058 – 97
Standard Specification for
Wrought Cobalt-Chromium-Nickel-Molybdenum-Iron Alloy
for Surgical Implant Applications
This standard is issued under the fixed designation F 1058; 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 AMS 5876 Alloy Strip, Corrosion and Heat Resistant 20Cr-
15Ni-40Co-7.0Mo-16Fe Solution Heat Treated and Cold
1.1 This specification covers the requirements for two
Rolled
grades of wrought cobalt-chromium-nickel-molybdenum-iron
2.3 American Society for Quality Control:
alloy in the form of wire and strip used for the manufacture of
C1 Specification of General Requirements for a Quality
surgical implants.
Program
1.2 The values stated in inch-pound units are to be regarded
2.4 ISO Standard:
as the standard.
ISO 5832-7 Implants for Surgery—Metal Based Products—
2. Referenced Documents
Part 7 Forgeable and Cold Formed Co-Cr-Ni-Mo-Fe
Alloy
2.1 ASTM Standards:
A 751 Methods, Practices, and Definitions for Chemical
3. Ordering Information
Analysis of Steel Products
3 3.1 Inquiries and orders for material under this specification
E 8 Methods of Tension Testing of Metallic Materials
shall include the following information:
E 18 Test Methods for Rockwell Hardness and Rockwell
3 3.1.1 Quantity (weight or number of pieces),
Superficial Hardness of Metallic Materials
3.1.2 Condition (4.11),
E 45 Practice for Determining the Inclusion Content of
4 3.1.3 Finish (4.2),
Steel
3.1.4 Mechanical properties (if applicable, for special con-
E 92 Test Method for Vickers Hardness of Metallic Mate-
3 ditions) (7.1),
rials
3.1.5 Applicable dimensions, including size, thickness,
E 112 Methods for Determining the Average Grain Size
width, and length (exact, random, multiples), or print number,
E 140 Hardness Conversion Tables for Metals (Relationship
3.1.6 Special tests, and
Between Brinell Hardness, Rockwell Hardness, Rockwell
3.1.7 Supplementary requirements (if applicable):
Superficial Hardness, and Knoop Hardness)
3.1.7.1 Product uniformity, and
2.2 Aerospace Material Specifications:
3.1.7.2 Additional tests or inspections, supplementary com-
AMS 2269 Chemical Check Analysis Limits Wrought
position limits, if any as required by the manufacturing process
Nickel and Alloys and Cobalt Alloys
and intended application, and other supplementary require-
AMS 5833 Alloy Wire, Corrosion and Heat Resistant 20Cr-
ments.
15Ni-40Co-7.0Mo-16Fe Solution Treated and Cold
Drawn
4. Materials and Manufacture
AMS 5834 Alloy Wire, Corrosion and Heat Resistant 20Cr-
4.1 Condition—Wire and strip shall be furnished to the
15Ni-40Co-7.0Mo-16Fe Solution Heat Treated, Cold
5 implant manufacturer in the cold worked or cold worked and
Drawn, and Aged
aged condition, as specified.
AMS 5875 Alloy Strip, Corrosion and Heat Resistant 20Cr-
4.2 Finish—Surface finish shall be as specified and required
15Ni-40Co-7.0Mo-16Fe Solution Heat Treated, Cold
5 by the subsequent manufacturing process and the intended
Rolled, and Aged
application.
This specification is under the jurisdiction of ASTM Committee F-4 on Medical 5. Chemical Requirements
and Surgical Materials and Devices, and is the direct responsibility of Subcommittee
5.1 The heat analysis shall conform to the requirements as
F4.12 on Metallurgical Materials.
to chemical composition specified in Table 1.
Current edition approved July 10, 1997. Published March 1998. Originally
approved as F 1058 - 91. Last previous edition F 1058 - 91.
Annual Book of ASTM Standards, Vol 01.03.
3 6
Annual Book of ASTM Standards, Vol 03.01. Available from American Society for Quality Control, 161 West Wisconsin
Annual Book of ASTM Standards, Vol 03.03. Ave., Milwaukee, WI 53203.
5 7
Available from Society of Automotive Engineers, 400 Commonwealth Drive, Available from American National Standards Institute, 1430 Broadway, New
Warrendale, PA 15096. York, NY 10018.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 1058
TABLE 1 Chemical Requirements, Heat Analysis TABLE 3 Mechanical Requirements, Cold Worked Wire
Composition, (%) Ultimate Tensile Strength,
Diameter inch (mm)
min, psi (MPa)
Element Grade 1 Grade 2
0.001 to 0.005, incl 260 000 (1795)
min max min max
(0.02 to 0.12)
Carbon . 0.15 . 0.15 Over 0.005 to 0.040, incl 240 000 (1655)
(0.12 to 1.00)
Manganese 1.5 2.5 1.0 2.0
Silicon . 1.20 . 1.20 Over 0.040 to 0.060, incl 235 000 (1620)
(1.00 to 1.50)
Phosphorus . 0.015 . 0.015
Sulfur . 0.015 . 0.015 Over 0.060 to 0.100, incl 225 000 (1550)
(1.50 to 2.50)
Cobalt 39.0 41.0 39.0 42.0
Chromium 19.0 21.0 18.5 21.5 Over 0.100 to 0.140, incl 220 000 (1515)
Nickel 14.0 16.0 15.0 18.0 (2.50 to 3.50)
Molybdenum 6.0 8.0 6.5 7.5
Beryllium . 0.10 . 0.001
A
Iron balance balance balance balance
A
TABLE 4 Mechanical Requirements, Cold Worked and Aged
A
Approximately equal to the difference between 100 % and the sum percentage
Wire
of the other specified elements. The percentage iron content by difference is not
Ultimate Tensile Yield Strength
required to be reported.
Diameter inch (mm) Strength, min, psi (0.2 % offset),
(MPa) min, psi (MPa)
0.001 to 0.005, incl 330 000 (2275) .
5.1.1 Requirements for the major and minor elemental
(0.02 to 0.12)
constituents for this alloy are listed in Table 1. Also listed are
Over 0.005 to 0.040, incl 290 000 (2000) 210 000 (1450)
(0.12 to 1.00)
important residual elements. Analysis for elements not listed in
Over 0.040 to 0.060, incl 285 000 (1965) 200 000 (1380)
Table 1 is not required to verify compliance with this specifi-
(1.00 to 1.50)
cation. Over 0.060 to 0.080, incl 275 000 (1895) 200 000 (1380)
(1.50 to 2.00)
5.2 Product analysis tolerances do not broaden the specified
Over 0.080 to 0.100, incl 275 000 (1895) 195 000 (1345)
heat analysis requirements, but cover variations between labo-
(2.00 to 2.50)
ratories in the measurement of chemical content. The manu- Over 0.100 to 0.120, incl 270 000 (1860) 185 000 (1275)
(2.50 to 3.00)
facturer shall not ship material that is outside the limits
Over 0.120 to 0.140, incl 270 000 (1860) 180 000 (1240)
specified in Table 1. Product analysis limits shall be specified
(3.00 to 3.50)
in Table 2 and in accordance with AMS 2269. A
Thermally aged by heating to a temperature within the range 900° to 1000°F
(480° to 540°C), holding at the selected temperature within 625°F (615°C) for 5
5.3 Methods and practices relating to chemical analysis
to 5 ⁄2 h, and cooling in air to room temperature.
required by this specification shall be in accordance with
Methods A 751.
TABLE 5 Mechanical Requirements, Cold Worked Strip
Ultimate Tensile Strength, min, psi
6. Metallurgical Requirements
Thickness, inch (mm)
(MPa)
6.1 The material shall have a homogeneous cold worked
Up to 0.0043, incl 260 000 (1795)
microstructure as observed at 1003 magnification.
(0.110)
Over 0.0043 to 0.01875, incl 250 000 (1725)
6.2 The grain size shall be ASTM 5 or finer, based on the
(0.110 to 0.4688)
appropriate chart of Methods E 112.
Over 0.01875 to 0.025, i
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