Recognized standard
18193 First edition 2021-08
FDA recognition 3-176 · ISO · Cardiovascular
Key facts
| Recognition number | 3-176 |
|---|---|
| Designation | 18193 First edition 2021-08 |
| Title | Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements for sterile, single-use cannulae for removal and delivery of patients' blood during cardiopulmonary bypass (CPB) up to 6 h duration, extracorporeal lung assist (ECLA with VV, VAV, or AV cannulation strategies), left or right heart bypass (LHB, RHB)… |
At a glance
- 10–99 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: