Recognized standard
8536-10 Second Edition 2015-06-15
FDA recognition 6-360 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-360 |
|---|---|
| Designation | 8536-10 Second Edition 2015-06-15 |
| Title | Infusion Equipment for Medical Use - Part 10: Accessories for 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 8536-10:2015 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8. ISO 8536-10:2015 includes the following: a) two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold; b) units with injection site or… |
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: