YY 0948-2025
YY 0948-2025 Cardiopulmonary bypass systems—Arteriovenous cannula for single use
Abstract
This document specifies the requirements for single-use sterile arterial-venous catheters used for draining or perfusing blood during the implementation of cardiopulmonary bypass, extracorporeal lung assistance, left or right heart bypass, cardiopulmonary support, extracorporeal life support, extracorporeal carbon dioxide removal, and other extracorporeal circulation techniques, and describes the corresponding test methods.
This document applies to single-use sterile arterial-venous catheters used for draining or perfusing blood.
This document does not apply to:
——Guiding devices (such as guidewires) described in YY 0450.1—2020;
——Isolated organ perfusion catheters;
——Vascular intravascular catheters described in YY 0285.3—2017.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Pending |
| Standard Code | YY 0948-2025 |
| CCS | Extracorporeal circulation, artificial organs, and prosthetic devices |
| ICS | Surgical implants, prostheses, and orthoses |
| Implement Date | 2028-07-01 |