Recognized standard
21535 Third edition 2023-07
FDA recognition 11-401 · ISO · Orthopedic
Key facts
| Recognition number | 11-401 |
|---|---|
| Designation | 21535 Third edition 2023-07 |
| Title | Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Sep 11, 2023 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This document specifies requirements for hip-joint replacement implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods… |
At a glance
- 10–99 Product codes
- 10–99 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: