ASTM F562-00
(Specification)Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant Applications
Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant Applications
SCOPE
1.1 This specification covers the requirements for a wrought cobalt-35 nickel-20 chromium-10 molybdenum alloy in the form of bars and wires, used for the manufacture of surgical implants. This alloy depends on combinations of work-strengthening, and work-strengthening and aging to attain a variety of combinations of strength and ductility.
1.2 The values stated in inch-pound units are to be re- garded as the standard.
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
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Designation: F 562 – 00
Standard Specification for
Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum
Alloy for Surgical Implant Applications UNS R 30035
This standard is issued under the fixed designation F 562; 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 2.5 Society of Automotive Engineers:
SAE J1086 Practice for Numbering Metals and Alloys
1.1 This specification covers requirements of wrought
(UNS)
cobalt-35 nickel-20 chromium-10 molybdenum alloy in the
form of bars and wires, used for the manufacture of surgical
3. Terminology
implants. This alloy depends on combinations of work-
3.1 Description of Term Specific to This Standard:
strengthening, and work-strengthening and aging to attain a
3.1.1 capability—the word capability is used to indicate the
variety of combinations of strength and ductility.
ability of cold worked material to attain specific mechanical
1.2 The values stated in inch-pound units are to be regarded
properties after thermal aging treatment.
as the standard. The metric equivalents of the inch-pound units
may be approximate.
4. Ordering Information
4.1 Inquiries and orders for material under this specification
2. Referenced Documents
shall include the following information:
2.1 ASTM Standards:
2 4.1.1 Quantity (weight or number of pieces),
E 8 Test Methods for Tension Testing of Metallic Materials
4.1.2 ASTM designation and date of issue,
E 112 Test Methods for Determining the Average Grain
2 4.1.3 Form (1.1),
Size
4.1.4 Condition (5.1),
E 354 Test Methods for Chemical Analysis of High-
4.1.5 Mechanical properties (if applicable),
Temperature, Electrical, Magnetic, and Other Similar Iron,
4.1.6 Finish (9.2),
Nickel, and Cobalt Alloys
4.1.7 Applicable dimensions, including size, thickness,
F 981 Practice for Assessment of Compatibility of Bioma-
width, and length (exact, random, multiples), or print number,
terials for Surgical Implants with Respect to Effect of
4 4.1.8 Special tests, and
Materials on Muscle and Bone
4.1.9 Special requirements.
2.2 Federal Standard:
Federal Test Method No. 151 Metals; Test Methods
5. Materials and Manufacture
2.3 Aerospace Material Specifications:
5.1 Condition—Bar and wire shall be furnished , as speci-
AMS 2269 Chemical Check Analysis Limits—Wrought
6 fied, in the solution-annealed, cold-worked, or cold-worked
Nickel Alloys and Cobalt Alloys
and aged condition.
2.4 American Society for Quality Standard:
ASQC1 Specification of General Requirements for a Qual-
6. Chemical Requirements
ity Program
6.1 The cobalt-35 nickel-20 chromium-10 molybdenum al-
loy shall conform to the chemical requirements prescribed in
1 Table 1. The supplier shall not ship material that is outside the
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of limits specified in Table 1.
Subcommittee F04.12on Metallurgical Materials.
6.1.1 Requirements for the major and minor elemental
Current edition approved May 10, 2000. Published August 2000. Originally
constituents are listed in Table 1. Also listed are important
published as F 562 – 78. Last previous edition F 562 – 95.
residual elements. Analysis for elements not listed in Table 1 is
Annual Book of ASTM Standards, Vol 03.01.
Annual Book of ASTM Standards, Vol 03.05.
not required to verify compliance with this specification.
Annual Book of ASTM Standards, Vol 13.01.
6.2 Product Analysis—The product analysis is either for the
Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700
purpose of verifying the composition of a heat or lot or to
Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
Available from Society of Automotive Engineers, Inc., 400 Commonwealth determine variations in the composition within the heat.
Drive, Warrendale, PA 15096–0001.
6.2.1 Acceptance or rejection of a heat or lot of material
Available from American Society for Quality, 161 West Wisconsin Ave.,
Milwaukee, WI 53203.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 562
TABLE 1 Chemical Requirements
of a straight draw bench at room temperature. A round bar shall
Composition,% (mass/mass) be cold drawn 53 % to a smaller round bar.
Element
7.4 The level of mechanical properties for material in other
min max
than the solution-annealed or 53 % cold-worked and aged
Carbon . 0.025
condition shall be specified in the purchase order.
Manganese . 0.15
Silicon . 0.15
Phosphorus . 0.015 8. Special Tests
Sulfur . 0.010
8.1 The grain size of bar product shall be predominantly No.
Chromium 19.0 21.0
Nickel 33.0 37.0
4 or finer with occasional grains as large as No. 2 permissible
Molybdenum 9.0 10.5
when tested in accordance with Test Methods E 112.
Iron . 1.0
8.1.1 It is preferred that samples for grain size determination
Titanium . 1.0
Boron . 0.015 be selected after the last annealing operation and prior to the
A
Cobalt balance balance
final cold-working operation.
A
Approximately equal to the difference between 100 % and the sum percentage
8.1.2 If samples are selected after final cold-working opera-
of the other specified elements. The percentage cobalt content by difference is not
tions, transverse specimens shall be prepared.
required to be reported.
8.2 For other than bar product, the grain size shall be agreed
upon between the purchaser and the manufacturer.
may be made by the purchaser on the basis of this product
9. Workmanship, Finish, and Appearance
analysis.
6.2.2 Product analysis tolerances do not broaden the speci-
9.1 All products shall be free from external and internal
fied heat analysis requirements but cover variations between
imperfections detrimental to the intended purpose.
laboratories in the measurement of chemical content. Product 9.2 Finish—Types of finish available in bar and wire
analysis limits shall be as specified in Table 2.
products are cold-drawn, pickled, ground, ground and polished,
or as specified in the
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