Recognized standard
7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15
FDA recognition 11-339 · ISO · Orthopedic
Key facts
| Recognition number | 11-339 |
|---|---|
| Designation | 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 |
| Title | Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ] |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This part of ISO 7206 specifies requirements for the articulating surfaces of those types of total and partial hip joint prostheses that provide a joint replacement of ball and socket configuration, as follows: a) sphericity and surface finish requirements for metallic and ceramic femoral prostheses… |
At a glance
- 10–99 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: