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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 034 Date of Entry 01/30/2014 
FR Recognition Number 11-274
Standard
ISO  18192-2 First edition 2010-06-15
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements
Scope/Abstract
This part of ISO 18192 defines a test procedure for spinal nucleus prostheses under the relative angular movement conditions specified by ISO 18192-1.

This part of ISO 18192 is applicable to both lumbar and cervical prostheses. It is not applicable to total disc replacements and facet joint replacements. The method includes wear and fatigue testing. Additional mechanical tests such as creep tests can be required.

This part of ISO 18192 does not reproduce the complex in vivo loads and motions. The wear and fatigue data obtained with this test method will enable comparison between different types of implant but can differ from the clinical wear performance. The user of this part of ISO 18192 should consider running additional tests addressing specific safety issues of the individual implant design to be tested.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
N/A Prosthesis, Intervertebral Disc Class 3 MJO
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
 Jonathan Peck
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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