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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Entry 07/15/2019 
FR Recognition Number 8-518
Standard
ASTM  F3306-19
Standard Test Method for Ion Release Evaluation of Medical Implants
Scope/Abstract

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 s 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 method.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Shiril Sivan
  FDA/OC/CDRH/OSEL/DAM/
  240-402-4125
  Shiril.Sivan@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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