ASTM F90-97

Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)

SCOPE
1.1 This specification covers the requirements for wrought cobalt-20chromium-15tungsten-10nickel alloy used for surgical implants. The properties specified apply specifically to wrought bar, rod, wire, sheet, and strip, but do not apply to surgical fixation wire (see Specification F 1091).
1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents in parentheses are for information only.

General Information

• Status: Historical
• Publication Date: 09-Oct-2001
• 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 F90-01 - Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
• Effective Date: 10-Oct-2001
• Referred By: ASTM F981-23 - Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
• Effective Date: 10-Oct-2001
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 10-Oct-2001
• 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-Oct-2001
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
• Effective Date: 10-Oct-2001
• Referred By: ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
• Effective Date: 10-Oct-2001
• Referred By: ASTM F1091-20 - Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
• Effective Date: 10-Oct-2001
• Referred By: ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 10-Oct-2001
• Referred By: ASTM F647-22 - Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
• Effective Date: 10-Oct-2001
• Referred By: ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 10-Oct-2001
• Referred By: ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
• Effective Date: 10-Oct-2001
• Referred By: ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
• Effective Date: 10-Oct-2001

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 90 – 97
Standard Specification for
Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy
for Surgical Implant Applications (UNS R30605)
This standard is issued under the fixed designation F 90; 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. General Requirements for Delivery
1.1 This specification covers the requirements for wrought 3.1 In addition to the requirements of this specification, all
cobalt-20 chromium-15 tungsten-10 nickel alloy bar, wire, requirements of the current editions of Specifications A 480/
sheet, and strip used for the manufacture of surgical implants. A 480M, A484/A 484M, and A 555/A 555M shall apply.
1.2 The values stated in inch-pound units are to be regarded 3.2 In the case where a conflict exists between this specifi-
as the standard. cation and those listed in 2.1-2.3, this specification shall take
precedence.
2. Referenced Documents
4. Ordering Information
2.1 ASTM Standards:
A 480/A 480M Specification for General Requirements for 4.1 Inquiries and orders for material under this specification
Flat-Rolled Stainless and Heat-Resisting Steel Plate, shall include the following information:
Sheet, and Strip 4.1.1 Quantity (weight or number of pieces),
A 484/A 484M Specification for General Requirements for 4.1.2 ASTM designation,
Stainless and Heat-Resisting Bars, Billets, and Forgings 4.1.3 Form (bar, wire, sheet, strip),
A 555/A 555M Specification for General Requirements for 4.1.4 Condition (see 6.1),
Stainless Steel Wire and Wire Rods 4.1.5 Finish (see 6.2),
A 751 Test Methods, Practices, and Terminology for 4.1.6 Mechanical properties (if applicable, for special con-
Chemical Analysis of Steel Products ditions),
E 8 Test Method for Tension Testing of Metallic Materials 4.1.7 Applicable dimensions including size, thickness,
E 354 Test Methods for Chemical Analysis of High- width, and length (exact, random or multiples) or print number,
Temperature, Electrical, Magnetic, and Other Similar Iron, and
Nickel, and Cobalt Alloys 4.1.8 Other requirements.
F 981 Practice for Assessment of Compatibility of Bioma-
5. Manufacture
terials for Surgical Implants with Respect to Effect of
Materials in Muscle and Bone 5.1 Condition—Bar, wire, sheet, and strip shall be furnished
to the implant manufacturer, as specified, in the annealed or
F 1091 Specification for Wrought Cobalt-Chromium Alloy
Surgical Fixation Wire cold-worked condition.
5.2 Finish:
2.2 Aerospace Material Specification:
5.2.1 Types of finish available for bar and wire are bright-
AMS 2269 Chemical Check Analysis Limits, Wrought
Nickel Alloys and Cobalt Alloys annealed, pickled, cold-drawn, ground, ground and polished or
as specified in the implant manufacturer’s purchase order.
2.3 American Society for Quality Control (ASQC) Stan-
dard: 5.2.2 Types of finish available for sheet and strip are
brightannealed, pickled, cold-rolled, polished or as specified in
C1 Specification of General Requirements for a Quality
Program the implant manufacturer’s purchase order.
6. Chemical Requirements
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
6.1 The heat analysis shall conform to the requirements as
and Surgical Materials and Devicesand is the direct responsibility of Subcommittee
to chemical composition specified in Table 1.
F04.12 on Metallurgical Materials.
Current edition approved June 10, 1997. Published March 1998. Originally 6.1.1 Requirements for the major and minor elemental
published as F 90 – 68. Last previous edition F 90 – 96.
constituents are listed in Table 1. Also listed are important
Annual Book of ASTM Standards, Vol 01.03.
3 residual elements. Analysis for elements not listed in Table 1 is
Annual Book of ASTM Standards, Vol 03.01.
not required to certify compliance with this specification.
Annual Book of ASTM Standards, Vol 03.05.
Annual Book of ASTM Standards, Vol 13.01.
6.2 Product Analysis—Product analysis tolerances do not
Available from American Society for Quality Control, 161 W. Wisconsin Ave.,
broaden the specified heat analysis requirements, but cover
Milwaukee, WI 53203.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F90
TABLE 1 Chemical Requirements
6.2.2 Acceptance or rejection of a heat or lot may be made
Composition, % by the purchaser on the basis of this check analysis.
Element
6.3 For referee purposes, Test Methods E 354 shall be used.
min max
6.4 Methods and practices relating to chemical analysis
Carbon 0.05 0.15
required by this specification shall be in accordance with Test
Manganese 1.00 2.00
Silicon . 0.40
Methods A 751.
Phosphorus . 0.040
Sulfur . 0.030
7. Mechanical Requirements
Chromium 19.00 21.00
Nickel 9.00 11.00
7.1 The material in the annealed condition shall conform to
Tungsten 14.00 16.00
the mechanical properties specified in Tables 3 and 4.
Iron . 3.00
A
7.2 The level of mechanical properties for material in other
Cobalt balance balance
than the annealed condition shall be specified in the implant
A
Approximately equal to the difference between 100 % and the sum percentage
of the other specified elements. The percentage cobalt content by difference is not manufacturer’s purchase order.
required to be reported.
7.3 Specimens for tension tests shall be machined and tested
in accordance with Test Method E 8.
variations between laboratories in the measurement of chemi-
8. Additional Requirements
cal content. The manufacturer shall not ship material that is
outside the limits specified in Table 1. Product analysis limits
8.1 Any additional requirements shall be specified on the
shall be as specified in Table 2. purchase order.
6.2.1 The
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