ASTM F90-23
(Specification)Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought cobalt-20chromium-15tungsten-10nickel alloy bars, rods, wires, sheets, and strips (except surgical fixation wires) for use in surgical implants. All alloys shall be furnished to the purchaser's specifications, in the annealed or cold-worked condition. Then, bars and wires shall be finished bright annealed, cold drawn, pickled, ground, or ground and polished, as specified by the purchaser. While, sheets shall be furnished bright annealed, pickled, cold-rolled, or polished, as specified by the purchaser. The alloys shall adhere to specified values of ultimate tensile strength, yield strength, elongation, and microcleanliness.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical 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 F1091).
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
- Status
- Published
- Publication Date
- 31-Mar-2023
- Technical Committee
- F04 - Medical and Surgical Materials and Devices
- Drafting Committee
- F04.12 - Metallurgical Materials
Relations
- Effective Date
- 01-Jan-2024
- Effective Date
- 01-Jan-2024
- Effective Date
- 01-Nov-2023
- Effective Date
- 01-Sep-2023
- Effective Date
- 01-Mar-2023
- Effective Date
- 05-May-2020
- Effective Date
- 01-Feb-2020
- Effective Date
- 01-Sep-2019
- Effective Date
- 01-Mar-2019
- Effective Date
- 01-Nov-2018
- Effective Date
- 01-Jan-2018
- Effective Date
- 15-Jul-2016
- Effective Date
- 01-Jan-2016
- Effective Date
- 01-Jan-2016
- Effective Date
- 01-Feb-2015
Overview
ASTM F90-23 is the standard specification developed by ASTM International for wrought cobalt-20chromium-15tungsten-10nickel alloy (UNS R30605) intended for surgical implant applications. The document defines chemical, mechanical, and metallurgical requirements for the alloy, covering products such as bars, rods, wires, sheets, and strips (excluding surgical fixation wire). The specification ensures that materials supplied meet the stringent demands required for biocompatibility and mechanical integrity in medical devices, specifically implants designed for use in the human body.
Key Topics
- Product Forms: Covers wrought bar, rod, wire, sheet, and strip. Each form must comply with precise dimensional, finish, and property requirements.
- Chemical Composition: Specifies allowable ranges for elements such as cobalt, chromium, tungsten, nickel, carbon, manganese, and iron, ensuring consistent alloy performance.
- Mechanical Properties: Defines minimum ultimate tensile strength, yield strength, and elongation for both annealed and cold-worked conditions, supporting predictable performance under physiological stresses.
- Metallurgical Structure: Outlines requirements for microcleanliness (such as inclusion content) to ensure reliable long-term function and compatibility.
- Material Condition and Finish: Materials may be furnished annealed or cold-worked, and available finishes include bright annealed, cold drawn, pickled, ground, or polished, as specified by the purchaser.
- Unit Systems: Allows use of either SI or inch-pound units, but mandates use of a single unit system for each certification.
- Quality Management: Encourages adherence to internationally recognized quality systems, such as ISO 9001 or ISO 13485.
Applications
The ASTM F90-23 standard is primarily used in the production of surgical implants that require high strength, corrosion resistance, and biocompatibility. Typical applications include:
- Orthopedic Implants: Joint components, plates, and load-bearing structures.
- Cardiovascular Devices: Components requiring long-term contact with body fluids and tissues.
- Dental Prosthetics: Where high wear resistance and stability are critical.
- Other Long-Term Medical Implants: Where wear, fatigue resistance, and compatibility with bodily tissues are essential.
The use of cobalt-chromium-tungsten-nickel alloy (commonly referred to as L-605) is supported by its long-term clinical history and robust material properties, which promote excellent implant performance with an acceptable biological response.
Related Standards
ASTM F90-23 is part of a broader family of standards for medical materials. Related references include:
- ASTM F1091: Specification for surgical fixation wire made from the same base alloy.
- ASTM F2527: Covers cobalt alloy tubing for surgical implants.
- ASTM E8/E8M: Test methods for tension testing of metallic materials.
- ISO 5832-5: Wrought cobalt-chromium-tungsten-nickel alloy for surgical implants.
- ISO 9001 & ISO 13485: Essential quality management system standards for healthcare and medical device manufacturing.
- AMS 5759: Aerospace specification for similar cobalt-based alloys.
The compatibility and harmonization with both ASTM and ISO standards ensure international acceptance and support for regulatory conformance in global markets.
Keywords: cobalt alloys for surgical implants, cobalt-chromium alloy, ASTM F90, UNS R30605, medical device materials, biocompatibility, orthopedic implant materials, L-605 alloy.
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Frequently Asked Questions
ASTM F90-23 is a technical specification published by ASTM International. Its full title is "Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)". This standard covers: ABSTRACT This specification covers the chemical, mechanical, and metallurgical requirements for wrought cobalt-20chromium-15tungsten-10nickel alloy bars, rods, wires, sheets, and strips (except surgical fixation wires) for use in surgical implants. All alloys shall be furnished to the purchaser's specifications, in the annealed or cold-worked condition. Then, bars and wires shall be finished bright annealed, cold drawn, pickled, ground, or ground and polished, as specified by the purchaser. While, sheets shall be furnished bright annealed, pickled, cold-rolled, or polished, as specified by the purchaser. The alloys shall adhere to specified values of ultimate tensile strength, yield strength, elongation, and microcleanliness. SCOPE 1.1 This specification covers the chemical, mechanical, and metallurgical 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 F1091). 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
ABSTRACT This specification covers the chemical, mechanical, and metallurgical requirements for wrought cobalt-20chromium-15tungsten-10nickel alloy bars, rods, wires, sheets, and strips (except surgical fixation wires) for use in surgical implants. All alloys shall be furnished to the purchaser's specifications, in the annealed or cold-worked condition. Then, bars and wires shall be finished bright annealed, cold drawn, pickled, ground, or ground and polished, as specified by the purchaser. While, sheets shall be furnished bright annealed, pickled, cold-rolled, or polished, as specified by the purchaser. The alloys shall adhere to specified values of ultimate tensile strength, yield strength, elongation, and microcleanliness. SCOPE 1.1 This specification covers the chemical, mechanical, and metallurgical 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 F1091). 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
ASTM F90-23 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F90-23 has the following relationships with other standards: It is inter standard links to ASTM A484/A484M-24, ASTM E8/E8M-24, ASTM E45-18a(2023), ASTM A484/A484M-23a, ASTM A484/A484M-23, ASTM A484/A484M-20a, ASTM F1091-20, ASTM A484/A484M-19, ASTM E539-19, ASTM A484/A484M-18a, ASTM A484/A484M-18, ASTM E8/E8M-16, ASTM A555/A555M-16, ASTM A484/A484M-16, ASTM E8/E8M-15. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ASTM F90-23 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F90 − 23
Standard Specification for
Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for
Surgical Implant Applications (UNS R30605)
This standard is issued under the fixed designation F90; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope* E8/E8M Test Methods for Tension Testing of Metallic Ma-
terials
1.1 This specification covers the chemical, mechanical, and
E29 Practice for Using Significant Digits in Test Data to
metallurgical requirements for wrought cobalt-20chromium-
Determine Conformance with Specifications
15tungsten-10nickel alloy used for surgical implants. The
E45 Test Methods for Determining the Inclusion Content of
properties specified apply specifically to wrought bar, rod,
Steel
wire, sheet, and strip, but do not apply to surgical fixation wire
E354 Test Methods for Chemical Analysis of High-
(see Specification F1091).
Temperature, Electrical, Magnetic, and Other Similar Iron,
1.2 The values stated in either SI units or inch-pound units
Nickel, and Cobalt Alloys
are to be regarded separately as standard. The values stated in
E539 Test Method for Analysis of Titanium Alloys by
each system may not be exact equivalents; therefore, to ensure
Wavelength Dispersive X-Ray Fluorescence Spectrometry
conformance with the standard, each system shall be used
E1409 Test Method for Determination of Oxygen and Nitro-
independently of the other, and values from the two systems
gen in Titanium and Titanium Alloys by Inert Gas Fusion
shall not be combined.
E1447 Test Method for Determination of Hydrogen in Re-
1.3 This standard does not purport to address all of the
active Metals and Reactive Metal Alloys by Inert Gas
safety concerns, if any, associated with its use. It is the Fusion with Detection by Thermal Conductivity or Infra-
responsibility of the user of this standard to establish appro-
red Spectrometry
priate safety, health, and environmental practices and deter- E1941 Test Method for Determination of Carbon in Refrac-
mine the applicability of regulatory limitations prior to use.
tory and Reactive Metals and Their Alloys by Combustion
1.4 This international standard was developed in accor-
Analysis
dance with internationally recognized principles on standard- E2994 Test Method for Analysis of Titanium and Titanium
ization established in the Decision on Principles for the
Alloys by Spark Atomic Emission Spectrometry and Glow
Development of International Standards, Guides and Recom- Discharge Atomic Emission Spectrometry (Performance-
mendations issued by the World Trade Organization Technical
Based Method)
Barriers to Trade (TBT) Committee. E2371 Test Method for Analysis of Titanium and Titanium
Alloys by Direct Current Plasma and Inductively Coupled
2. Referenced Documents
Plasma Atomic Emission Spectrometry (Performance-
2.1 ASTM Standards: Based Test Methodology)
A484/A484M Specification for General Requirements for E2626 Guide for Spectrometric Analysis of Reactive and
Stainless Steel Bars, Billets, and Forgings Refractory Metals (Withdrawn 2017)
A555/A555M Specification for General Requirements for F981 Practice for Assessment of Compatibility of Biomate-
Stainless Steel Wire and Wire Rods rials for Surgical Implants with Respect to Effect of
Materials on Muscle and Insertion into Bone
F1091 Specification for Wrought Cobalt-20Chromium-
This specification is under the jurisdiction of ASTM Committee F04 on
15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
R30605)
Current edition approved April 1, 2023. Published April 2023. Originally
IEEE/ASTM SI 10 American National Standard for Metric
approved in 1968. Last previous edition approved in 2014 as F90 – 14. DOI:
Practice
10.1520/F0090-23.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F90 − 23
2.2 Aerospace Material Specifications: 5.2.2 Sheet shall be furnished bright annealed, pickled,
AMS 2269 Chemical Check Analysis Limits, Wrought cold-rolled, or polished, as specified by the purchaser.
Nickel Alloys and Cobalt Alloys
6. Chemical Requirements
AMS 5759 Cobalt Alloy, Corrosion and Heat Resistant Bars,
Forgings, and Rings, 52Co-20Cr-10Ni-15W, Solution
6.1 The supplier’s heat analysis shall conform to the chemi-
Heat Treated
cal composition prescribed in Table 1. The supplier shall not
2.3 ISO Standards: ship material with chemistry outside the requirements specified
in Table 1.
ISO 5832-5 Wrought Cobalt-Chromium-Tungsten-Nickel
Alloy 6.1.1 Requirements for the major and minor elemental
constituents are listed in Table 1. Also listed are important
ISO 6892 Metallic Materials Tensile Testing at Ambient
Temperature residual elements.
6.1.2 All commercial metals may contain small amounts of
ISO 9001 Quality System—Requirements
ISO 13485 Medical Devices—Quality Management elements other than those which are specified. It is neither
practical nor necessary to specify limits for unspecified ele-
Systems—Requirements for Regulatory Purposes
ments that can be present. The producer is permitted to analyze
3. Product Classification for unspecified elements and is permitted to report such
analyses. The presence of an unspecified element and the
3.1 Bar—Round, rectangular, or other complex shaped
reporting of an analysis for that element shall not be a basis for
product delivered straightened and cut to defined lengths, with
2 2 rejection unless previously agreed to between purchaser and
a maximum cross-sectional area of 103 cm [16 in. ].
supplier.
3.2 Wire—Round, rectangular, or other complex shapes of
6.1.3 Intentional elemental additions other than those speci-
uniform cross section along its entire length furnished in coils,
fied in Table 1 are not permitted.
or on spools, reels, or other packaging as specified.
6.1.4 Analysis for elements not listed in Table 1 is not
required to verify compliance with this specification.
3.3 Fine Wire—Wire with diameter or major dimension less
6.1.5 Methods and practices relating to chemical analysis
than 1.6 mm. [0.063 in.].
required by this specification shall be in accordance with Test
Methods E354.
4. Ordering Information
4.1 Inquiries and orders for material under this specification 6.2 Product (Check) Analysis—The product (check) analy-
sis tolerances shall conform to the product tolerances in Table
shall include the following information:
4.1.1 Quantity; 2 per AMS 2269. Product analysis tolerances do not broaden
the specified heat (ladle or ingot) analysis requirements but
4.1.2 ASTM designation and date of issue;
4.1.3 Mechanical properties (see Section 8); cover variations between laboratories in the measurement of
chemical content.
4.1.4 Form (bar, rod, wire, sheet, strip);
6.2.1 Product (check) analysis limits are not for the supplier/
4.1.5 Applicable dimensions including size, thickness,
producer’s use at acceptance testing. Product analysis limits
width, and length (exact, random, or multiples) or drawing
are not permitted to be applied to ladle or ingot analysis. The
number;
4.1.6 Tolerances—Unless otherwise specified by purchaser, supplier/producer shall not ship material that is outside the
limits specified in Table 1.
tolerances must meet the requirements of Specification A484/
A484M or A555/A555M, or both, as applicable; 6.2.2 A product (check) analysis is one performed by the
purchaser or the supplier of the metal after it has been worked
4.1.7 Condition (see 5.1);
4.1.8 Finish (see 5.2); into one of the forms listed in Section 3 on Product
Classification, and is either for the purpose of verifying the
4.1.9 Special tests (if any); and
4.1.10 Other requirements.
5. Materials and Manufacture
TABLE 1 Chemical Requirements
Composition, % (mass ⁄mass)
5.1 Condition—Bar, wire, sheet, and strip shall be furnished
Element
min max
to the purchaser, as specified, in the annealed cold-worked, or
Carbon 0.05 0.15
cold worked and aged condition.
Manganese 1.00 2.00
5.2 Finish: Silicon . . . 0.40
Phosphorus . . . 0.040
5.2.1 Bar and wire shall be furnished bright annealed,
Sulfur . . . 0.030
cold-drawn, pickled, ground, or ground and polished, as
Chromium 19.00 21.00
specified by the purchaser. Nickel 9.00 11.00
Tungsten 14.00 16.00
Iron . . . 3.00
A
Cobalt balance balance
A
Available from Society of Automotive Engineers (SAE), 400 Commonwealth
Approximately equal to the difference between 100 % and the sum percentage
Dr., Warrendale, PA 15096-0001, http://www.sae.org.
of the other specified elements. The percentage of the cobalt difference is not
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
required to be reported.
4th Floor, New York, NY 10036, http://www.ansi.org.
F90 − 23
A
TABLE 2 Product Analysis Tolerances
8.1.5 Tensile tests results for which any specimen fractures
Tolerance Under the Minimum Limit or Over the
outside the gauge length shall be considered acceptable if the
Element
B
Maximum Limit
elongation meets the minimum requirement specified. Refer to
Carbon 0.01
7.11.4 of Test Methods E8/E8M. If the elongation is less than
Manganese 0.04
the minimum requirement, discard the test and retest. Retest
Silicon 0.03
Phosphorous 0.005
one specimen for each specimen that did not meet the
Sulfur 0.005
minimum requirements.
Chromium 0.25
Nickel 0.15 under min; 0.20 over max
9. Dimensions and Permissible Variations
Tungsten 0.25
Iron 0.07
9.1 Units of Measure:
A
Refer to AMS 2269.
9.1.1 Selection—This specification requires that the pur-
B
Under minimum limit not applicable for elements where only a maximum
chaser selects the
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F90 − 14 F90 − 23
Standard Specification for
Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for
Surgical Implant Applications (UNS R30605)
This standard is issued under the fixed designation F90; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope*
1.1 This specification covers the chemical, mechanical, and metallurgical 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 F1091).
1.2 The SI units in this standard are the primary units. Values in primary SI or secondary values stated in either SI units or
inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore
therefore, to ensure conformance with the standard, each system shall be used independentindependently of the other.
Combiningother, and values from the two systems may result in non-conformance with the specification.shall not be combined.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
A484/A484M Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
A751A555/A555M Test Methods and Practices for Chemical Analysis of Steel ProductsSpecification for General Requirements
for Stainless Steel Wire and Wire Rods
E8/E8M Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E45 Test Methods for Determining the Inclusion Content of Steel
E354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and
Cobalt Alloys
E539 Test Method for Analysis of Titanium Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
E1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas Fusion
E1447 Test Method for Determination of Hydrogen in Reactive Metals and Reactive Metal Alloys by Inert Gas Fusion with
Detection by Thermal Conductivity or Infrared Spectrometry
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved Nov. 1, 2014April 1, 2023. Published January 2015April 2023. Originally approved in 1968. Last previous edition approved in 20092014 as
F90 – 09.F90 – 14. DOI: 10.1520/F0090-14.10.1520/F0090-23.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F90 − 23
E1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
E2994 Test Method for Analysis of Titanium and Titanium Alloys by Spark Atomic Emission Spectrometry and Glow Discharge
Atomic Emission Spectrometry (Performance-Based Method)
E2371 Test Method for Analysis of Titanium and Titanium Alloys by Direct Current Plasma and Inductively Coupled Plasma
Atomic Emission Spectrometry (Performance-Based Test Methodology)
E2626 Guide for Spectrometric Analysis of Reactive and Refractory Metals (Withdrawn 2017)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
F1091 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
F2527 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)
IEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric
SystemMetric Practice
2.2 Aerospace Material Specification:Specifications:
AMS 2269 Chemical Check Analysis Limits, Wrought Nickel Alloys and Cobalt Alloys
AMS 5759 Cobalt Alloy, Corrosion and Heat Resistant Bars, Forgings, and Rings, 52Co – 20 Cr – 10Ni – 15W,
52Co-20Cr-10Ni-15W, Solution Heat Treated
2.3 ISO Standards:
ISO 5832-5 Wrought Cobalt-Chromium-Tungsten-Nickel Alloy
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperature
ISO 9001 Quality System—Requirements
ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
2.4 American Society for Quality (ASQ) Standard:
C1 Specification of General Requirements for a Quality Program
3. Product Classification
3.1 Bar—Round, rectangular, or other complex shaped product delivered straightened and cut to defined lengths, with a maximum
2 2
cross-sectional area of 16 in.103 cm (103 cm [16 in. ).].
3.2 Wire—Round, rectangular, or other complex shaped product produced and delivered in coils. shapes of uniform cross section
along its entire length furnished in coils, or on spools, reels, or other packaging as specified.
3.3 Fine Wire—Wire with diameter or major dimension less than 0.063 in. (1.6 mm).1.6 mm. [0.063 in.].
4. Ordering Information
4.1 Inquiries and orders for material under this specification shall include the following information:
4.1.1 Quantity,Quantity;
4.1.2 ASTM designation and date of issue,issue;
4.1.3 Mechanical properties (see Section 78),);
4.1.4 Form (bar, rod, wire, sheet, strip),strip);
4.1.5 Applicable dimensions including size, thickness, width, and length (exact, random, or multiples) or drawing number,number;
4.1.6 Tolerances—Unless otherwise specified by purchaser, tolerances must meet the requirements of Specification A484/A484M
or A555/A555M, or both, as applicable;
4.1.7 Condition (see 5.1),);
The last approved version of this historical standard is referenced on www.astm.org.
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.org.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
F90 − 23
4.1.8 Finish (see 5.2),);
4.1.9 Special tests (if any); and
4.1.10 Other requirements.
5. Materials and Manufacture
5.1 Condition—Bar, wire, sheet, and strip shall be furnished to the purchaser, as specified, in the annealed cold-worked, or cold
worked and aged condition.
5.2 Finish:
5.2.1 Bar and wire shall be furnished bright annealed, cold drawn, cold-drawn, pickled, ground, or ground and polished, as
specified by the purchaser.
5.2.2 Sheet shall be furnished bright annealed, pickled, cold-rolled, or polished, as specified by the purchaser.
6. Chemical Requirements
6.1 The supplier’s heat analysis shall conform to the chemical composition of prescribed in Table 1. The supplier shall not ship
material that iswith chemistry outside the limitsrequirements specified in Table 1.
6.1.1 Requirements for the major and minor elemental constituents are listed in Table 1. Also listed are important residual
elements. Analysis for elements not listed in Table 1 is not required to verify compliance with this specification.
6.1.2 All commercial metals may contain small amounts of elements other than those which are specified. It is neither practical
nor necessary to specify limits for unspecified elements that can be present. The producer is permitted to analyze for unspecified
elements and is permitted to report such analyses. The presence of an unspecified element and the reporting of an analysis for that
element shall not be a basis for rejection unless previously agreed to between purchaser and supplier.
6.1.3 Intentional elemental additions other than those specified in Table 1 are not permitted.
6.1.4 Analysis for elements not listed in Table 1 is not required to verify compliance with this specification.
TABLE 1 Chemical Requirements
Composition, % (mass/
mass)(mass ⁄mass)
Element
min maxmax
Carbon 0.05 0.15
Carbon 0.05 0.15
Manganese 1.00 2.00
Manganese 1.00 2.00
Silicon . 0.40
Silicon . . . 0.40
Phosphorus . 0.040
Phosphorus . . . 0.040
Sulfur . 0.030
Sulfur . . . 0.030
Chromium 19.00 21.00
Nickel 9.00 11.00
Nickel 9.00 11.00
Tungsten 14.00 16.00
Iron . 3.00
Iron . . . 3.00
A
Cobalt balance balance
A
Cobalt balance balance
A
Approximately equal to the difference between 100 % and the sum percentage
of the other specified elements. The percentage of the cobalt difference is not
required to be reported.
F90 − 23
6.1.5 Methods and practices relating to chemical analysis required by this specification shall be in accordance with Test Methods
E354.
6.2 Product (Check) Analysis—The product analysis is either for the purpose of verifying(check) analysis tolerances shall conform
to the product tolerances in Table 2the composition of a heat or lot or to determine variations in the composition within the heat.
per AMS 2269. Product analysis tolerances do not broaden the specified heat (ladle or ingot) analysis requirements but cover
variations between laboratories in the measurement of chemical content.
6.2.1 Product (check) analysis limits are not for the supplier/producer’s use at acceptance testing. Product analysis limits are not
permitted to be applied to ladle or ingot analysis. The supplier/producer shall not ship material that is outside the limits specified
in Table 1.
6.2.2 A product (check) analysis is one performed by the purchaser or the supplier of the metal after it has been worked into one
of the forms listed in Section 3 on Product Classification, and is either for the purpose of verifying the composition of a heat or
manufacturing lot or to determine variations in the composition within the heat.
6.2.3 Acceptance or rejection of a heat or lot of material may be made by the purchaser on the basis of this product
analysis.(check) analysis. Product (check) analysis outside the tolerance limits allowed in Table 2 is cause for rejection of the
product. A referee analysis may be used if agreed upon by supplier and purchaser.
6.2.4 Product analysis tolerances do not broaden the specified heat analysis requirements but instead cover variations between
laboratories in the measurement of chemical content. Product analysis limits shall be as specified Methods and practices relating
to chemical analysis required by this specification shall be in Table 2accordance with Test Methods E354.
6.2.5 For referee purposes, use Test Methods E539, E1409, E1447, E1941, E2994, and E2371 and Guide E2626, or other
analytical methods agreed upon between the purchaser and the supplier.
6.3 For referee purposes, Test Methods E354 shall be used.
6.4 Methods and practices relating to chemical analysis required by this specification shall be in accordance with Test Methods
A751.
7. Metallurgical Requirements
7.1 The microcleanliness of the alloy as determined by Method A of Test Methods E45, except using Plate I-r, on representative
billet or bar samples from the heat shall not exceed the limits of Table 3.
8. Mechanical Requirements
7.1 The material in the annealed condition shall conform to the mechanical properties specified in Tables 3 and 4.
7.2 Material in the cold worked condition shall conform to the mechanical properties specified in Table 3.
A
TABLE 2 Product Analysis Tolerances
Tolerance Under the Minimum Limit or Over the
Element
B
Maximum Limit
Carbon 0.01
Manganese 0.04
Silicon 0.03
Phosphorous 0.005
Sulfur 0.005
Chromium 0.25
Nickel 0.15 under min; 0.20 over max
Tungsten 0.25
Iron 0.07
A
Refer to AMS 2269.
B
Under minimum limit not applicable for elements where only a maximum
percentage is indicated.
F90 − 23
TABLE 53 Microcleanliness Requirements
D
Inclusion A B C
(Globular
Type (Sulfide) (Alumina) (Silicate)
Oxides)
Thin 1.5 1.5 1.5 1.5
Heavy 1.0 1.0 1.0 1.0
7.3 The cold worked and aged condition may be ordered in accordance with mechanical property requirements agreed upon
between supplier and purchaser.
8.1 Tensile properties shall be determined in accordance with Test Methods E8/E8M. Perf
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