Recognized standard
18192-3 First edition 2017-06
FDA recognition 11-353 · ISO · Orthopedic
Key facts
| Recognition number | 11-353 |
|---|---|
| Designation | 18192-3 First edition 2017-06 |
| Title | Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | This document defines a test procedure to simulate and evaluate lumbar spinal disc prostheses wear under adverse impingement conditions. |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: