Recognized standard
17327-1 First edition 2018-02
FDA recognition 8-517 · ISO · Materials
Key facts
| Recognition number | 8-517 |
|---|---|
| Designation | 17327-1 First edition 2018-02 |
| Title | Non-active surgical implants - Implant coating - Part 1: General requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | This document specifies general requirements for implant coatings, comprising both surface coatings and surface modifications, applied to non-active surgical implants. This document specifies requirements concerned with generic coating properties including chemical and phase compositions, surface… |
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: