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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 11-351
Standard
ISO  18192-1 Second edition 2011-03-01
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
Scope/Abstract
This part of ISO 18192 defines a test procedure for the relative angular movement between articulating components, and specifies the pattern of the applied force, speed and duration of testing, sample configuration and test environment for use for the wear testing of total intervertebral spinal disc prostheses.

Both lumbar and cervical prostheses are addressed. This part of ISO 18192 is not applicabe to partial disc replacements, such as nucleus replacements or facet joint replacements. The test method focuses on wear testing. Additional mechanical tests, such as fatigue testing, can be required.

This part of ISO 18192 does not reproduce the complex in vivo loads and motions. The wear data obtained with this test method enables comparison between different types of implants, but can differ from the clinical wear performance. The user of this part of ISO 18192 can consider running additional wear tests addressing specific safety issues of the individual implant design under test.
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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