Recognized standard
6009 Fourth edition 2016-08-01
FDA recognition 6-381 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-381 |
|---|---|
| Designation | 6009 Fourth edition 2016-08-01 |
| Title | Hypodermic needles for single use - Colour coding for identification. |
| 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 6009:2016 establishes a colour code for the identification of single-use hypodermic needles of designated metric in the range of 0,18 mm (34 Gauge) to 3,4 mm (10 Gauge) . It applies to regular-walled, thin-walled, extra-thin-walled and ultra-thin walled needles, and to opaque and translucent… |
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: