YY/T 1739-2020 Cardiopulmonary bypass systems—Centrifugal pump-head English
1 Scope
This standard specifies requirements for sterile, single-use, extracorporeal centrifugal pump-heads, whether coated, surface-modified, or non-surface modified, intended for producing blood flow during extracorporeal circulation. Such blood flow is most commonly used to provide systemic perfusion during cardiopulmonary bypass, but also has applications for veno-venous bypass, kinetic-assisted venous drainage, and extracorporeal membrane oxygenation.
This standard does not apply to centrifugal pumps used as ventricular assist devices, and other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipment for medical use—Part 1: chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices–Part 1: Evaluation and testing within a risk management process (ISO 10993-1: 2009, IDT)
GB 18279.1 Sterilization of health-care products—Ethylene oxide—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18279.1-2015, ISO 11135-1: 2007, IDT)
GB 18280.1 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (GB 18280.1—2015, ISO 11137-1: 2006, IDT)
GB 19335-2003 Blood flow products for single use—General specification
GB/T 19633.1 Packaging for terminally sterilized medical devices—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 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes (GB/T 19633.2-2015, ISO 11607-2: 2006, IDT)
GB/T 19974 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices (GB/T 19974-2018, ISO 14937: 2009, IDT)
YY/T 0681.1 Test methods for sterile medical device package—Part 1: Test guide for accelerated aging
Pharmacopoeia of the People's Republic of China
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
centrifugal pump-head
extracorporeal device designed to produce rotational flow by means of radial force
3.2
blood pathway
paths of the pump containing blood during intended clinical use
3.3
operating variables
settings of controls that affect the function of the device
3.4
blood cell damage
loss or destruction of cellular components of the blood
3.5
platelet reduction
percentage reduction of platelets contained in a circuit incorporating a centrifugal pump as a function of time
3.6
plasma-free hemoglobin level
concentration of plasma-free hemoglobin in a circuit incorporating a centrifugal pump, as a function of time
3.7
normalized index of hemolysis; NIH
grams of plasma-free hemoglobin released after pumping 100L of blood
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Information supplied by the manufacturer
7 Packaging
Annex A (Informative) Technical differences between this standard and ISO 18242: 2016 and their causes
Bibliography
