Recognized standard
10555-5 Second edition 2013-06-15
FDA recognition 6-303 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-303 |
|---|---|
| Designation | 10555-5 Second edition 2013-06-15 |
| Title | Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 10555-5:2013 specifies requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use. |
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: