YY/T 1739-2020Cardiopulmonary bypass systems—Centrifugal pump-head (English PDF)

1 Scope

This standard specifies the single-use sterile centrifugal pump head (with or without coating, surface modification) used to generate blood flow during extracorporeal circulation.

Or non-surface modification) requirements. The blood flow provided by the pump head of the centrifugal pump is often used for the perfusion of the cardiopulmonary bypass system, venous-venous bypass, and power assist

Helps venous drainage and extracorporeal membrane oxygenation.

This standard does not apply to centrifugal pumps of ventricular assist devices and other components of extracorporeal circulation circuits (such as blood tubing, pump console/driver).

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article

Pieces. For undated references, the latest version (including all amendments) applies to this document.

GB/T 14233.1-2008 Medical transfusion, blood transfusion, injection equipment inspection methods Part 1.Chemical analysis methods

GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management (ISO 10993-1.

2009, IDT)

GB 18279.1 Sterilization of medical and health care products ethylene oxide Part 1.Development, validation and routine control of the sterilization process of medical devices

System requirements (GB 18279.1-2015, ISO 11135-1.2007, IDT)

GB 18280.1 Medical and health products sterilization radiation Part 1.Medical device sterilization process development, validation and routine control requirements

Seek (GB 18280.1-2015, ISO 11137-1..2006, IDT)

GB 19335-2003 General technical requirements for single-use blood circuit products

GB/T 19633.1 Terminally sterilized medical device packaging Part 1.Requirements for materials, sterile barrier systems and packaging systems (GB/T 19633.1-2015, ISO 11607-1.2006, IDT)

GB/T 19633.2 Terminally sterilized medical device packaging Part 2.Requirements for confirmation of forming, sealing and assembly process (GB/T 19633.2-2015, ISO 11607-2.2006, IDT)

GB/T.19974 The characteristics of sterilization factors for medical and healthcare products and the development, validation and routine control of the sterilization process of medical devices

General requirements (GB/T.19974-2018, ISO 14937.2009, IDT)

YY/T 0681.1 Sterile medical device packaging test method Part 1.Guide to accelerated aging test

Pharmacopoeia of the People's Republic of China

3 Terms and definitions

The following terms and definitions apply to this document.