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ASTM F961-03

(Specification)

Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]

Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]

SCOPE
1.1 This specification covers the requirements for 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) forgings for surgical implants.
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-Feb-2003
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 F961-96 - Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]
Effective Date
10-Feb-2003
Replaced By
ASTM F961-08 - Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
Effective Date
01-Aug-2008

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ASTM F961-03 - Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]ASTM F961-03 - Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]
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ASTM F961-03 - Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 961 – 03
Standard Specification for
35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy
1
Forgings for Surgical Implants (UNS R30035)
This standard is issued under the fixed designation F 961; 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 2.2 ISO Standard:
ISO 5832-6 Implants for Surgery–Metallic Materials–Part
1.1 This specification covers the requirements for 35cobalt-
6: Wrought Cobalt-Nickel-Chromium-Molybdenum Al-
35nickel-20chromium-10molybdenum alloy (UNS R30035)
5
loy
forgings for surgical implants.
2.3 American Society for Quality Control Standard:
1.2 The values stated in inch-pound units are to be regarded
ASQ C1 Specification of General Requirements for a Qual-
as the standard. The SI equivalents in parentheses are for
6
ity Program
information only.
3. Ordering Information
2. Referenced Documents
3.1 Inquiries and orders for material under this specification
2.1 ASTM Standards:
shall include the following information:
A 751 Test Methods, Practices, and Terminology for
2
3.1.1 Quantity (weight or number of pieces),
Chemical Analysis of Steel Products
3 3.1.2 ASTM designation and date of issue,
E 8 TestMethodsforTensionTestingofMetallicMaterials
3.1.3 Mechanicalproperties(ifapplicable,forotherrequire-
E 10 Test Method for Brinell Hardness of Metallic Materi-
3
ments),
als
3.1.4 Form,
E 18 Test Methods for Rockwell Hardness and Rockwell
3
3.1.5 Applicable dimensions, including size, thickness,
Superficial Hardness of Metallic Materials
width, and length (exact, random, multiples), or drawing
E 92 Test Method for Vickers Hardness of Metallic Mate-
3
number,
rials
3
3.1.6 Condition,
E 112 Test Methods for Determining Average Grain Size
3.1.7 Finish,
E 140 Hardness Conversion Tables for Metals Relationship
3.1.8 Special tests (if any), and
Among Brinell Hardness, Vickers Hardness, Rockwell
3.1.9 Other requirements.
Hardness, Superficial Hardness, Knoop Hardness, and
3
Scleroscope Hardness
4. Materials and Manufacture
F 562 Specification for Wrought 35Cobalt-35Nickel-
4.1 Material for forgings shall be bars, plate, sheet, or wire
20Chromium-10Molybdenum Alloy for Surgical Implant
4 manufactured in accordance with Specification F 562 or Speci-
Applications (UNS R30035)
fication F 688. The material shall be generally in the solution-
F 601 Practice for Fluorescent Penetrant Inspection of Me-
4 annealed condition with a finish suitable for forging.
tallic Surgical Implants
4.2 The material shall be forged by hammering, pressing,
F 688 Specification for Wrought 35Cobalt-35Nickel-
rolling, extruding, or upsetting and shall be processed, if
20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil
4 practicable, so as to cause metal flow to be in the most
for Surgical Implants (UNS R30035)
favorable direction for resisting stresses encountered in ser-
F 981 Practice for Assessment of Compatibility of Bioma-
vice, as may be indicated to the supplier by the purchaser.
terials for Surgical Implants with Respect to Effect of
4 4.3 Forgings shall be free of splits, scale, cracks, inequali-
Materials on Muscle and Bone
ties, flaws, and other imperfections not consistent with good
commercial practice.
1
This specification is under the jurisdiction of ASTM Committee F04 on
NOTE 1—CompliancetotheserequirementsmaybeverifiedbyPractice
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials
Current edition approved Feb. 10, 2003. Published March 2003. Originally
5
approved in 1985. Last previous edition approved in 1996 as F 961 – 96. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
2
Annual Book of ASTM Standards, Vol 01.03. 4th Floor, New York, NY 10036.
3 6
Annual Book of ASTM Standards, Vol 03.01. Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
4
Annual Book of ASTM Standards, Vol 13.01. Milwaukee, WI 53203.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F961–03
F 601 or other suitable method. NOTE 2—When desired, Brinell hardness may be taken as described in
Test Method E 10 or Vickers hardness may be taken as described in Test
4.4 When specified by the purchaser, a thermal treatment
Method E 92 and converted to Rockwell hardness in accordance with
shall be performed, as specified, after all forging operations are
Hardness Conversion Tables E 140.
performed.
6.4 Specimensfortensiontestsshallbemachinedandtested
4.5 Optional identification marks, including th
...

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1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
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1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
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1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.  
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SIGNIFICANCE AND USE
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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1.6 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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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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    English language
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