Recognized standard
7199 Third edition 2016-11-15 7199:2016
FDA recognition 3-150 · ISO · Cardiovascular
Key facts
| Recognition number | 3-150 |
|---|---|
| Designation | 7199 Third edition 2016-11-15 7199:2016 |
| Title | Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators). |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans. This document also applies to heat exchangers and arterial filters that are integral parts of the… |
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: