Recognized standard
F2847-17
FDA recognition 8-472 · ASTM · Materials
Key facts
| Recognition number | 8-472 |
|---|---|
| Designation | F2847-17 |
| Title | Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | 1.1 The purpose of this practice is to describe how the cleanliness of single-use implants as manufactured shall be reported. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods. 1.2 The practice does not address substances which… |
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: