Recognized standard
19227 First edition 2018-03
FDA recognition 11-348 · ISO · Orthopedic
Key facts
| Recognition number | 11-348 |
|---|---|
| Designation | 19227 First edition 2018-03 |
| Title | Implants for surgery - Cleanliness of orthopedic implants - General requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Jan 14, 2019 |
| Scope (excerpt) | This document specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process. This document does not specify requirements for packaging or… |
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: