Recognized standard
8536-9 Second Edition 2015-06-15
FDA recognition 6-359 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-359 |
|---|---|
| Designation | 8536-9 Second Edition 2015-06-15 |
| Title | Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Apr 4, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 8536-9:2015 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by ISO 8536-9:2015: a) syringe pump lines (SPL); b) connecting lines (CL); c) lines with integrated injection cannula (LIC). |
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: