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YY/T 1739-2020 English PDF

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YY/T 1739-2020: Cardiopulmonary bypass systems - Centrifugal pump-head
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Basic data

Standard ID YY/T 1739-2020 (YY/T1739-2020)
Description (Translated English) Cardiopulmonary bypass systems - Centrifugal pump-head
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 18,197
Date of Issue 2020-06-30
Date of Implementation 2021-12-01
Issuing agency(ies) State Drug Administration

YY/T 1739-2020: Cardiopulmonary bypass systems - Centrifugal pump-head

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Cardiopulmonary bypass systems - Centrifugal pump-head ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Cardiopulmonary bypass system centrifugal pump pump head 2020-06-30 released 2021-12-01 implementation Issued by the State Drug Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the redrafting method to modify and adopt the standard ISO 18242.2016 "Centrifugal Blood Pump for Cardiovascular Implants and Extracorporeal Systems". Compared with ISO 18242.2016, this standard has technical differences, and the clauses involved in these differences have been passed in the blank position of the outer page number. The vertical straight line (│) is marked, and a list of the corresponding technical differences and their reasons is given in Appendix A. This standard also made the following editorial changes. ---Modified the standard name. Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Technical Committee for Medical Extracorporeal Circulation Equipment (SAC/TC158). Drafting organizations of this standard. Guangdong Medical Device Quality Supervision and Inspection Institute, Mai Kewei (Shanghai) Medical Equipment Co., Ltd., Renofa (China) China) Medical Technology Co., Ltd. The main drafters of this standard. Xu Suhua, Li Shengxia, Hong Liangtong, Liang Zexin, He Xiaofan, Li Aijun, Yang Rui'e.

Introduction

The purpose of this standard is to ensure that the centrifugal pump head used to support or replace the normal pumping function of the heart can continue to provide blood delivery to determine It is safe and effective, and when marking the device, it ensures that the relevant characteristics of the product are specified. This standard specifies relevant methods for evaluating pump heads of in vitro centrifugal pumps, such as methods for evaluating hydraulic performance, blood cell destruction and other performance indicators. Law, does not stipulate the limit value of such indicators. The preliminary identification of the above-mentioned performance will help users choose products that suit the needs of patients. The indicators mentioned in this standard are the minimum standard requirements. Users can compare the performance of different types of centrifugal pump heads with reference to the standard. This standard does not involve related requirements for animal and clinical research, the research can be used as part of the manufacturer's quality system. This standard only relates to the special requirements for the pump head of the centrifugal pump. For other requirements, refer to the referenced documents in Chapter 2. Cardiopulmonary bypass system centrifugal pump pump head

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. 3.1 Centrifugal pump head An extracorporeal device that generates swirling flow by centrifugal force. 3.2 Blood channel The path that blood will travel through the pump during clinical use.

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