Recognized standard
F3186-17
FDA recognition 6-407 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-407 |
|---|---|
| Designation | F3186-17 |
| Title | Standard Specification for Adult Portable Bed Rails and Related Products |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 1 |
| Scope (excerpt) | 1.1 This safety specification establishes performance requirements for adult portable bed rails, related products, and adult portable bedrail accessories, including requirements for resistance to entrapment, marking and adhered labels, instructional literature, and advertising. 1.2 This standard is… |
At a glance
- 1–9 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: