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ASTM F3306-19

(Test Method)

Standard Test Method for Ion Release Evaluation of Medical Implants

Standard Test Method for Ion Release Evaluation of Medical Implants

SIGNIFICANCE AND USE
5.1 Components of implanted medical devices can release ions, which may lead to adverse biological effects if released in sufficient quantities. Therefore, it may be necessary to characterize the ion release behavior over time to verify that a medical device or device components, or both, will not pose an unacceptable risk to patients. Some examples of when time-dependent ion release testing should be considered include:  
5.1.1 New materials,  
5.1.2 New applications (for example, different in-vivo environments or new designs) that may degrade corrosion resistance,  
5.1.3 Manufacturing processes that may lead to increased ion release susceptibility,  
5.1.4 Results of other corrosion testing (for example, Test Methods F2129 and F3044) indicate high susceptibility to corrosion.  
5.2 Forming and finishing steps used to create an implantable device may have significant effects on the ion release behavior of the material from which the device is fabricated. Preconditioning can impact the ion release behavior of implants; therefore, prior to testing, devices should be subjected to preconditioning that is appropriate to their application. A justification shall be provided if preconditioning is omitted. Additional information on preconditioning is found in Appendix X1. Substitute test articles (tubes, plates, wires, device subcomponents, etc.) may be used for testing with adequate justification, if all processing steps, including sterilization and preconditioning, are comparable to the finished device.  
5.3 To accommodate the wide variety of device shapes and sizes likely to be encountered, various sizes and shapes of containers manufactured from various materials can be used. The container material choice should be justified.  
5.4 Note that the test conditions described in this test method may not completely simulate those encountered in vivo (cells, proteins, mechanical loading, and other specifics of the in-vivo environment); however, the results of this tes...
SCOPE
1.1 This test method assesses metal or other ions released from single-use, metallic, implantable medical devices, or components thereof, by exposing the device to solutions simulating the in-vivo environment and temperature in a container for a predetermined time frame with regular sampling at adequate intervals. Examples of device types that may be evaluated by this test method include, but are not limited to: cardiovascular devices, endovascular devices, and orthopedic implants. Devices which are to be partially implanted, but in long-term contact within the body (such as external fixation devices) may also be evaluated using this method.  
1.2 This test method is used to assess devices or device components, or both, in their final form and finish, as they would be implanted. For modular implants, consideration should be given to individual testing of every part.  
1.3 This test method covers the selection of specimens, specimen preparation, test environment, method of exposure, and method for evaluating the results to characterize ion release. Because of the variety of configurations and sizes of implants, a variety of specimen container configurations may be used.  
1.4 This test method is not intended for ions only adsorbed onto the surface of the samples.  
1.5 This test method does not apply to absorbable metallic implants (for example, magnesium-based stents, bone screws, etc.) that are intentionally designed to degrade in-vivo.  
1.6 This test method does not cover the required subsequent chemical analysis, for example, by inductively coupled plasma mass spectrometry (ICP-MS), or the validation of the analytical instrumentation.  
1.7 This test method does not cover the influence of dynamic loading and associated surface damage or wear on ion release. Ion release may change under dynamic loading conditions and wear. Additional testing may be required, depending on the application and outcome of this test ...

General Information

Status
Published
Publication Date
31-Jan-2019
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.15 - Material Test Methods
Current Stage
Ref Project

Relations

Refers
ASTM F2129-17a - Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Effective Date
15-Nov-2017
Refers
ASTM F2129-15 - Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Effective Date
01-Mar-2015
Refers
ASTM F2129-17 - Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Effective Date
01-Jan-2017
Refers
ASTM F2129-17b - Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Effective Date
01-Dec-2017
Refers
ASTM F2129-19 - Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Effective Date
01-Jan-2019
Refers
ASTM F2129-19a - Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Effective Date
15-Jan-2019
Referred By
ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
Effective Date
01-Feb-2019

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ASTM F3306-19 - Standard Test Method for Ion Release Evaluation of Medical Implants
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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: F3306 − 19
Standard Test Method for
1
Ion Release Evaluation of Medical Implants
This standard is issued under the fixed designation F3306; 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 1.8 Units—The values stated in SI units are to be regarded
as standard. No other units of measurement are included in this
1.1 This test method assesses metal or other ions released
standard.
from single-use, metallic, implantable medical devices, or
1.9 This standard does not purport to address all of the
components thereof, by exposing the device to solutions
safety concerns, if any, associated with its use. It is the
simulating the in-vivo environment and temperature in a
responsibility of the user of this standard to establish appro-
container for a predetermined time frame with regular sam-
priate safety, health, and environmental practices and deter-
pling at adequate intervals. Examples of device types that may
mine the applicability of regulatory limitations prior to use.
be evaluated by this test method include, but are not limited to:
1.10 This international standard was developed in accor-
cardiovascular devices, endovascular devices, and orthopedic
dance with internationally recognized principles on standard-
implants. Devices which are to be partially implanted, but in
ization established in the Decision on Principles for the
long-term contact within the body (such as external fixation
Development of International Standards, Guides and Recom-
devices) may also be evaluated using this method.
mendations issued by the World Trade Organization Technical
1.2 This test method is used to assess devices or device
Barriers to Trade (TBT) Committee.
components, or both, in their final form and finish, as they
would be implanted. For modular implants, consideration
2. Referenced Documents
should be given to individual testing of every part.
2
2.1 ASTM Standards:
1.3 This test method covers the selection of specimens,
D1193 Specification for Reagent Water
specimen preparation, test environment, method of exposure,
F2129 Test Method for Conducting Cyclic Potentiodynamic
and method for evaluating the results to characterize ion
Polarization Measurements to Determine the Corrosion
release. Because of the variety of configurations and sizes of
Susceptibility of Small Implant Devices
implants, a variety of specimen container configurations may
F3044 TestMethodforEvaluatingthePotentialforGalvanic
be used.
Corrosion for Medical Implants
3
2.2 ISO Standards:
1.4 This test method is not intended for ions only adsorbed
ISO 3696 Water for analytical laboratory use – Specification
onto the surface of the samples.
and test methods
1.5 This test method does not apply to absorbable metallic
ISO 10993-15 Biological evaluation of medical devices –
implants (for example, magnesium-based stents, bone screws,
Part 15: Identification and quantification of degradation
etc.) that are intentionally designed to degrade in-vivo.
products from metals and alloys
1.6 This test method does not cover the required subsequent
ISO 10993-17 Biological evaluation of medical devices –
chemical analysis, for example, by inductively coupled plasma
Part 17: Establishment of allowable limits for leachable
mass spectrometry (ICP-MS), or the validation of the analyti-
substances
cal instrumentation.
3. Terminology
1.7 This test method does not cover the influence of
3.1 Definitions:
dynamicloadingandassociatedsurfacedamageorwearonion
3.1.1 blank, n—a sample of the test solution prepared
release. Ion release may change under dynamic loading con-
without the specimen for baseline determination in the subse-
ditions and wear. Additional testing may be required, depend-
quent analysis.
ing on the application and outcome of this test method.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
and Surgical Materials and Devices and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.15 on Material Test Methods. the ASTM website.
3
Current edition approved Feb. 1, 2019. Published March 2019. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F3306-19. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright
...

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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.  
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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