| ISO 7199 Third edition 2016-11-15 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators). |
| Recognition Number | Cardiovascular |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 3-150 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Cardiovascular |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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 oxygenator.
This document also applies to external equipment unique to the use of the oxygenator.
| Regulation Number | Device Name | Device Class | Product Code |
| §870.4350 | Oxygenator, Cardiopulmonary Bypass | Class 2 | DTZ |
| Guidance for Cardiopulmonary Bypass Oxygenator 510(k) Submissions; Final Guidance for Industry and FDA Staff, Issued November 2000. |