Recognized standard
F3212-16(2023)
FDA recognition 6-400 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-400 |
|---|---|
| Designation | F3212-16(2023) |
| Title | Standard Test Method for Coring Testing of Huber Needles |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This test method covers the qualitative measurement of Huber-type needles' potential to remove septum material during implantable port access (1)2. 1.2 This test method does not address other issues that may include, but are not limited to, force measurement during the perforation/withdrawal… |
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: