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ASTM F90-07

(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 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
14-May-2007
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

Replaces
ASTM F90-01 - Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
Effective Date
15-May-2007
Replaced By
ASTM F90-09 - Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
Effective Date
01-Jun-2009
Referred By
ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
Effective Date
15-May-2007
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
15-May-2007
Referred By
ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
Effective Date
15-May-2007
Referred By
ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Effective Date
15-May-2007
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
15-May-2007
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
15-May-2007
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
15-May-2007
Referred By
ASTM F2180-17 - Standard Specification for Metallic Implantable Strands and Cables
Effective Date
15-May-2007
Referred By
ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
Effective Date
15-May-2007
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
15-May-2007
Referred By
ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
Effective Date
15-May-2007
Referred By
ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
Effective Date
15-May-2007
Referred By
ASTM F1091-20 - Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
Effective Date
15-May-2007

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ASTM F90-07 - Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)ASTM F90-07 - Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
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ASTM F90-07 - Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
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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 90 – 07
Standard Specification for
Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for
1
Surgical Implant Applications (UNS R30605)
ThisstandardisissuedunderthefixeddesignationF 90;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (e) indicates an editorial change since the last revision or reapproval.
3
1. Scope* 2.2 Aerospace Material Specification:
AMS 2269 Chemical Check Analysis Limits, Wrought
1.1 This specification covers the requirements for wrought
Nickel Alloys and Cobalt Alloys
cobalt-20chromium-15tungsten-10nickel alloy used for surgi-
AMS 5759 Cobalt Alloy, Corrosion and Heat Resistant
cal implants. The properties specified apply specifically to
Bars, Forgings, and Rings, 52Co – 20 Cr – 10Ni – 15W,
wrought bar, rod, wire, sheet, and strip, but do not apply to
Solution Heat Treated
surgical fixation wire (see Specification F 1091).
4
2.3 ISO Standards:
1.2 The values stated in inch-pound units are to be regarded
ISO 5832-5 Wrought Cobalt-Chromium-Tungsten-Nickel
as the standard. The SI equivalents in parentheses are for
Alloy
information only.
ISO 6892 Metallic Materials Tensile Testing at Ambient
2. Referenced Documents
Temperature
2
ISO 9001 Quality System—Requirements
2.1 ASTM Standards:
2.4 American Society for Quality (ASQ) Standard:
A 751 Test Methods, Practices, and Terminology for
C1 Specification of General Requirements for a Quality
Chemical Analysis of Steel Products
5
Program
E8 Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to
3. Classification
Determine Conformance with Specifications
3.1 Bar—Round, rectangular, or other complex shaped
E45 Test Methods for Determining the Inclusion Content
product delivered straightened and cut to defined lengths, with
of Steel
2 2
a maximum cross-sectional area of 16 in. (103 cm ).
E 354 Test Methods for Chemical Analysis of High-
3.2 Wire—Round, rectangular, or other complex shaped
Temperature, Electrical, Magnetic, and Other Similar Iron,
product produced and delivered in coils.
Nickel, and Cobalt Alloys
3.3 Fine Wire—Wire with diameter or major dimension less
F 981 Practice for Assessment of Compatibility of Bioma-
than 0.063 in. (1.6 mm).
terials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone
4. Ordering Information
F 1091 Specification for Wrought Cobalt-20Chromium-
4.1 Inquiries and orders for material under this specification
15Tungsten-10Nickel Alloy Surgical Fixation Wire [UNS
shall include the following information:
R30605]
4.1.1 Quantity,
F 2527 SpecificationforWroughtSeamlessandWeldedand
4.1.2 ASTM designation and date of issue,
Drawn Cobalt Alloy Small Diameter Tubing for Surgical
4.1.3 Mechanical properties (see Section 7),
Implants(UNSR30003,UNSR30008,UNSR30035,UNS
4.1.4 Form (bar, rod, wire, sheet, strip),
R30605, and UNS R31537)
4.1.5 Applicable dimensions including size, thickness,
width, and length (exact, random, or multiples) or drawing
number,
4.1.6 Condition (see 5.1),
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.1.7 Finish (see 5.2),
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
3
Current edition approved May 15, 2007. Published June 2007. Originally
Available from Society of Automotive Engineers (SAE), 400 Commonwealth
approved in 1968. Last previous edition approved in 2001 as F 90 – 01.
Dr., Warrendale, PA 15096-0001, http://www.sae.org.
2
4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
5
Standards volume information, refer to the standard’s Document Summary page on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
the ASTM website. Milwaukee, WI 53203, http://www.asq.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.
1

---------------------- Page: 1 ----------------------
F90–07
A
TABLE 2 Product Analysis Tolerances
4.1.8 Other requirements.
Tolerance Under the Minimum Limit or Over the
Element
B
Maximum Limit
5. Materials and Manufacture
Carbon 0.01
5.1 Condition—Bar, wire, sheet, and strip shall be furnished
Manganese 0.04
to the purchaser, as specified, in the annealed or cold-worked Silicon 0.03
Phosphorous 0.005
condition.
Sulfur 0.005
5.2 Finish:
Chromium 0.25
5.2.1 Bar and wire shall be furnished brig
...

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Standard Guide for Total Knee Replacement Loading Profiles

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4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
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1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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ASTM
ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.  
1.7 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.

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