Recognized standard
8536-11 Second Edition 2015-06-15
FDA recognition 6-361 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-361 |
|---|---|
| Designation | 8536-11 Second Edition 2015-06-15 |
| Title | Infusion Equipment for Medical Use - Part 11: Infusion Filters 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 8536-11:2015 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs. |
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: