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ASTM F1377-04

(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)

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 inch-pound units are to be regarded as the standard. The SI units given in parentheses are for information only.

General Information

Status
Historical
Publication Date
30-Sep-2004
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 F1377-98a - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS-R30075)
Effective Date
01-Oct-2004
Replaced By
ASTM F1377-08 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
Effective Date
01-Oct-2008
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
01-Oct-2004
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
01-Oct-2004
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-Oct-2004
Referred By
ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
Effective Date
01-Oct-2004
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
01-Oct-2004

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ASTM F1377-04 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)ASTM F1377-04 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
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ASTM F1377-04 - 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: F 1377 – 04
Standard Specification for
Cobalt-28Chromium-6Molybdenum Powder for Coating of
1
Orthopedic Implants (UNS R30075)
This standard is issued under the fixed designation F 1377; 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 ASQ Standards:
3
C1 General Requirements for a Quality Program
1.1 This specification covers the requirements for cobalt-
28chromium-6molybdenum alloy powders for use in fabricat-
3. Ordering Information
ingcoatingsoncobalt-28chromium-6molybdenumalloyortho-
3.1 Inquiries and orders for material under this specification
pedic implants.
shall include the following information:
1.2 Powderscoveredunderthisspecificationmaybeusedto
3.1.1 Quantity,
form coatings by sintering or thermal spraying techniques.
3.1.2 ASTM designation and date of issue,
1.3 This specification covers powder requirements only. It
3.1.3 Method of powder manufacturing,
does not address properties of the coatings formed from them.
3.1.4 Chemistry requirements,
1.4 The values stated in inch-pound units are to be regarded
3.1.5 Sieve analysis requirements,
as the standard. The SI units given in parentheses are for
3.1.6 Special tests, if any, and
information only.
3.1.7 Other requirements.
2. Referenced Documents
4. Significance and Use
2
2.1 ASTM Standards:
4.1 Coatings formed from metallic powders have become
B 214 Test Method for Sieve Analysis of Metal Powders
widely used as a means of improving tissue attachment to
B 215 Practices for Sampling Finished Lots of Metal Pow-
uncemented orthopedic joint prosthesis. Such coatings have
ders
also been demonstrated to improve bonding of acrylic cement
E 11 Specification for Wire Cloth and Sieves for Testing
to prostheses. This specification addresses the special require-
Purposes
ments of the metal powders used to form these coatings.
E 354 Test Methods for Chemical Analysis of High Tem-
perature, Electrical, Magnetic, and Other Similar Iron,
5. Materials and Manufacture
Nickel, and Cobalt Alloys
5.1 Powders may be manufactured by the rotating electrode
F 75 Specification for Cobalt-28Chromium-6Molybdenum
process, inert gas atomization, or other methods capable of
Castings and Casting Alloy for Surgical Implants (UNS
producing powder meeting the requirements of this specifica-
R30075)
tion.
F 981 Practice for Assessment of Compatibility of Bioma-
terials for Surgical Implants with Respect to Effect of
6. Chemical Composition
Materials on Muscle and Bone
6.1 The heat analysis of stock used to manufacture the
powder shall conform to the chemical analysis set forth in
1
This specification is under the jurisdiction of ASTM Committee F04 on
Table 1 of Specification F 75.
Medical and Surgical Materials and Devices and is the direct responsibility of
6.2 The product analysis tolerance shall conform to the
Subcommittee F04.12 on Metallurgical Materials.
requirements set forth in Table 2 of Specification F 75.
Current edition approved Oct. 1, 2004. Published October 2004. Originally
6.3 For referee purposes, Test Methods E 354 shall be used.
approved in 1992. Last previous edition approved in 1998 as F 1377 – 98a.
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 from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
the ASTM website. Milwaukee, WI 53203.
*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 ----------------------
F1377–04
7. Sieve Analysis Requirements alternative testing practice, as agreed upon between purchaser
and supplier. No foreign material shall be visible under these
7.1 Powder shall be sieved to the customer’s requirements
test conditions.
with screens conforming to Specification E 11. Sieve analysis
testing of the sieved powder for conformance to purchaser’s
9. Certification
particle size range requirements shall be performed according
9.1 Certification that the material meets the requirements of
to Test Method B 214. Powder sampling shall be performed
the specification shall be provided by the supplier. A report of
according to Test Method B 215.
the test results shall be furnished at the time of shipment.
8. Cleanliness Requirements
10. Quality Program Requirements
8.1 Powder shall be handled at all times so as to minimize
10.1 The powder supplier shall maintain a qua
...

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SCOPE
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A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
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1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
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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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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).  
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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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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.

  • Guide
    8 pages
    English language
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  • Guide
    8 pages
    English language
    sale 15% off