Recognized standard
18192-1 Second edition 2011-03-01
FDA recognition 11-351 · ISO · Orthopedic
Key facts
| Recognition number | 11-351 |
|---|---|
| Designation | 18192-1 Second edition 2011-03-01 |
| Title | 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)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | 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… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: