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ASTM F1377-13

(Specification)

Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)

Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)

ABSTRACT
This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders for coating of orthopedic implants. This specification covers powder requirements only and does not address coating properties. Materials may be manufactured by rotating electrode process, inert gas atomization, or other methods that meet the powder requirements of this specification. The powder shall conform to chemical composition, sieve analysis, and cleanliness requirements of this specification.
SCOPE
1.1 This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders for use in fabricating coatings on cobalt-28chromium-6molybdenum alloy orthopedic implants.  
1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques.  
1.3 This specification covers powder requirements only. It does not address properties of the coatings formed from them.  
1.4 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, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

General Information

Status
Historical
Publication Date
31-May-2013
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

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ASTM F1377-13 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)ASTM F1377-13 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
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REDLINE ASTM F1377-13 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)REDLINE ASTM F1377-13 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
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REDLINE ASTM F1377-13 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
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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:F1377 −13
Standard Specification for
Cobalt-28Chromium-6Molybdenum Powder for Coating of
1
Orthopedic Implants (UNS R30075)
This standard is issued under the fixed designation F1377; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* R31537, UNS R31538, and UNS R31539)
3
2.2 ISO Standard:
1.1 This specification covers the requirements for cobalt-
ISO 9001Quality Management Standard
28chromium-6molybdenum alloy powders for use in fabricat-
ingcoatingsoncobalt-28chromium-6molybdenumalloyortho-
3. Ordering Information
pedic implants.
3.1 Inquiriesandordersformaterialunderthisspecification
1.2 Powderscoveredunderthisspecificationmaybeusedto
shall include the following information:
form coatings by sintering or thermal spraying techniques.
3.1.1 Quantity,
1.3 This specification covers powder requirements only. It
3.1.2 ASTM designation and date of issue,
does not address properties of the coatings formed from them.
3.1.3 Method of powder manufacturing,
3.1.4 Chemistry requirements,
1.4 The values stated in either SI units or inch-pound units
3.1.5 Sieve analysis requirements,
are to be regarded separately as standard. The values stated in
3.1.6 Special tests, if any, and
each system may not be exact equivalents; therefore, each
3.1.7 Other requirements.
system shall be used independently of the other. Combining
values from the two systems may result in non-conformance
4. Significance and Use
with the standard.
4.1 Coatings formed from metallic powders have become
2. Referenced Documents
widely used as a means of improving tissue attachment to
2
uncemented orthopedic joint prosthesis. Such coatings have
2.1 ASTM Standards:
B214Test Method for Sieve Analysis of Metal Powders also been demonstrated to improve bonding of acrylic cement
to prostheses. This specification addresses the special require-
B215Practices for Sampling Metal Powders
E11Specification forWovenWireTest Sieve Cloth andTest ments of the metal powders used to form these coatings.
Sieves
5. Materials and Manufacture
E29Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
5.1 Powders may be manufactured by the rotating electrode
E354 Test Methods for Chemical Analysis of High-
process, inert gas atomization, or other methods capable of
Temperature,Electrical,Magnetic,andOtherSimilarIron,
producing powder meeting the requirements of this specifica-
Nickel, and Cobalt Alloys
tion.
F75Specification for Cobalt-28 Chromium-6 Molybdenum
6. Chemical Composition
Alloy Castings and Casting Alloy for Surgical Implants
(UNS R30075)
6.1 The heat analysis of stock used to manufacture the
F1537 Specification for Wrought Cobalt-28Chromium-
powder shall conform to the chemical analysis set forth in
6Molybdenum Alloys for Surgical Implants (UNS
Table1 of Specifications F75 or F1537 (Alloy 1 and Alloy 2
only).
1
This specification is under the jurisdiction of ASTM Committee F04 on
6.2 The product analysis tolerance shall conform to the
Medical and Surgical Materials and Devicesand is the direct responsibility of
requirements set forth in Table2 of Specifications F75 or
Subcommittee F04.12 on Metallurgical Materials.
F1537.
Current edition approved June 1, 2013. Published August 2013. Originally
approved in 1992. Last previous edition approved in 2008 as F1377–08. DOI:
6.3 For referee purposes, Test Methods E354 shall be used.
10.1520/F1377-13.
2
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
3
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.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 ----------------------
F1377−13
7. Sieve Analysis Requirements observed or calculated value shall be rounded to the nearest
unit in the last right hand digit used in expressing the
7.1 Powder shall be sieved to the customer’s requirements
specificationlimit,inaccordancewiththeRoundingMethodof
with screens conforming to Specification E11. Sieve analysis
Practice E29.
testing of the sieved powder for conformance to purchaser’s
particle size range requirements shall be performed according
10. Certification
to Test Method B214. Powder sampling shall be performed
according to Test Method B215.
10.1 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: F1377 − 08 F1377 − 13
Standard Specification for
Cobalt-28Chromium-6Molybdenum Powder for Coating of
1
Orthopedic Implants (UNS R30075)
This standard is issued under the fixed designation F1377; 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 requirements for cobalt-28chromium-6molybdenum alloy powders for use in fabricating
coatings on cobalt-28chromium-6molybdenum alloy orthopedic implants.
1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques.
1.3 This specification covers powder requirements only. It does not address properties of the coatings formed from them.
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values given in
parentheses are mathematical conversions to SI units that are provided for information only and are not considered stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in non-conformance with the standard.
2. Referenced Documents
2
2.1 ASTM Standards:
B214 Test Method for Sieve Analysis of Metal Powders
B215 Practices for Sampling Metal Powders
E11 Specification for Woven Wire Test Sieve Cloth and Test Sieves
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and
Cobalt Alloys
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
3
2.2 ASQ Standard:
ASQ C1 General Requirements for a Quality Program
3
2.2 ISO Standard:
ISO 9001 Quality Management Standard
3. Ordering Information
3.1 Inquiries and orders for material under this specification shall include the following information:
3.1.1 Quantity,
3.1.2 ASTM designation and date of issue,
3.1.3 Method of powder manufacturing,
3.1.4 Chemistry requirements,
3.1.5 Sieve analysis requirements,
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devicesand is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved Oct. 1, 2008June 1, 2013. Published October 2008August 2013. Originally approved in 1992. Last previous edition approved in 20042008 as
F1377 – 04.F1377 – 08. DOI: 10.1520/F1377-08.10.1520/F1377-13.
2
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.
3
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.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 ----------------------
F1377 − 13
3.1.6 Special tests, if any, and
3.1.7 Other requirements.
4. Significance and Use
4.1 Coatings formed from metallic powders have become widely used as a means of improving tissue attachment to uncemented
orthopedic joint prosthesis. Such coatings have also been demonstrated to improve bonding of acrylic cement to prostheses. This
specification addresses the special requirements of the metal powders used to form these coatings.
5. Materials and Manufacture
5.1 Powders may be manufactured by the rotating electrode process, inert gas atomization, or other methods capable of
producing powder meeting the requirements of this specification.
6. Chemical Composition
6.1 The heat analysis of stock used to manufacture the powder shall conform to the chemical analysis set forth in Table 1 of
SpecificationSpecifications F75. or F1537 (Alloy 1 and Alloy 2 only).
6.2 The product analysis tolerance shall
...

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Standard Guide for Total Knee Replacement Loading Profiles

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).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
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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