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YY 0604-2016 Active
YY 0604-2016 Cardiopulmonary bypass systems—Blood-gas exchangers(oxygenators)
Abstract
This standard specifies the requirements for blood gas exchangers (oxygenators) used in sterile, single-use cardiopulmonary bypass systems (hereinafter referred to as oxygenators). These devices are used to supply oxygen to human blood and remove carbon dioxide from the blood (extracorporeal circulation devices that assist or replace the respiratory function of the lungs).
This standard also applies to heat exchangers that are an integral part of oxygenators.
This standard does not apply to:
——implantable oxygenators;
——liquid oxygenators;
——extracorporeal circulation pipes;
——separate heat exchangers;
——separate accessories.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY 0604-2016 |
| CCS | Extracorporeal circulation, artificial organs, and prosthetic devices |
| ICS | Surgical implants, prostheses, and orthoses |
| Implement Date | 2018-01-01 |
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