Recognized standard
7864 Fourth edition 2016-08-01
FDA recognition 6-379 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-379 |
|---|---|
| Designation | 7864 Fourth edition 2016-08-01 |
| Title | Sterile hypodermic needles for single use - Requirements and test methods |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Sep 21, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric s 0,18 mm to 1,2 mm. It does not apply to those devices that are covered by their own standard such as dental needles and pen needles. |
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: