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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 066 Date of Entry 05/25/2026 
FR Recognition Number 11-444
Standard
ISO  18192-3 Second edition 2025-11
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar and cervical prostheses
Scope/Abstract
This document specifies a test procedure to simulate and to evaluate lumbar and cervical spinal disc prostheses wear under adverse impingement conditions.
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.
Transition Period
FDA recognition of ISO 18192-3 First edition 2017-06 [Rec# 11-353] will be superseded by recognition of ISO 18192-3 Second edition 2025-11 [Rec# 11-444]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-353] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 11-353] will not be accepted.
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*
Guidance for Industry and FDA Staff - Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs, issued April 2008.

Guidance for Industry and/or FDA Reviewers/Staff - Guidance Document for the Preparation of IDEs for Spinal Systems, issued January 2000.

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/
  301-796-6429
  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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