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YY 0485-2020 English PDF

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YY 0485-2020: Single-use cardioplegia delivery system
Status: Valid

YY 0485: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0485-2020English189 Add to Cart 3 days [Need to translate] Single-use cardioplegia delivery system Valid YY 0485-2020
YY 0485-2011English359 Add to Cart 3 days [Need to translate] Single-used cardioplegia delivery system Obsolete YY 0485-2011
YY 0485-2004English319 Add to Cart 3 days [Need to translate] Single use cardioplegia delivery system Obsolete YY 0485-2004

PDF similar to YY 0485-2020


Standard similar to YY 0485-2020

YY/T 0640   YY/T 0663.2   YY/T 0606.9   YY 0267   YY/T 0489   

Basic data

Standard ID YY 0485-2020 (YY0485-2020)
Description (Translated English) Single-use cardioplegia delivery system
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C45
Classification of International Standard 11.040.20
Word Count Estimation 10,116
Date of Issue 2020-06-30
Date of Implementation 2021-12-01
Issuing agency(ies) State Drug Administration

YY 0485-2020: Single-use cardioplegia delivery system

---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.
Single-use cardioplegia delivery system ICS 11.040.20 C45 People's Republic of China Pharmaceutical Industry Standard Replace YY 0485-2011 Cardioplegia perfusion device for single use 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 replaces YY 0485-2011 "Disposable Cardioplegia Perfusion Device", compared with YY 0485-2011, except for editorial The main technical changes are as follows. ---Added the requirements of pump pipe performance (see 4.2.1); ---Modified the requirements for the flow rate of the perfusion device (see 4.2.1.1, 4.2.6 of the.2011 edition); ---Modified the requirements of variable temperature performance (see 4.2.3, 4.2.3 of the.2011 edition); ---Added requirements for temperature adaptability (see 4.2.7); ---Added the requirements for corrosion resistance (see 4.4); ---Modified the pyrogen-free requirements and test methods (see 4.5.2, 5.5.2, 4.4.3 and 5.4.3 of the.2011 edition); ---Modified the test method of tightness (see 5.2.4, 5.2.4 of the.2011 edition); ---Inductively coupled plasma mass spectrometry has been added (see 5.3.3); --- The logo, label, instruction manual and packaging, transportation and storage have been deleted (see Chapter 6 and Chapter 7 of the.2011 edition). 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, Shandong Weigao Xinsheng Medical Devices Co., Ltd., Ningbo Filal Medical Supplies Co., Ltd. The main drafters of this standard. He Xiaofan, Xu Chaosheng, Xu Suhua, Liang Zexin, Xiong Wei, Wang Yi, Kong Jianming. The previous versions of the standard replaced by this standard are as follows. ---YY 0485-2004; ---YY 0485-2011. Cardioplegia perfusion device for single use

1 Scope

This standard specifies the structure, classification, requirements and test methods of disposable cardioplegia perfusion devices. This standard applies to single-use cardioplegia perfusion devices (hereinafter referred to as perfusion devices). Perfusion device for cardiopulmonary bypass open heart surgery Used for cardioplegia perfusion.

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 1962.1 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 1.General requirements GB/T 1962.2 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 2.Locking joints 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 GB 18278.1 Hygrothermal Sterilization of Medical and Healthcare Products Part 1.Development, Validation and Routine Control Requirements for the Sterilization Process of Medical Devices GB 18279.1 Sterilization of medical and health care products, ethylene oxide Part 1.Requirements for the development, validation and routine control of the sterilization process of medical devices GB 18280.1 Sterilization radiation of medical and health care products Part 1.Requirements for the development, validation and routine control of the sterilization process of medical devices GB 19335-2003 General technical requirements for single-use blood circuit products YY/T 0149-2006 Stainless steel medical equipment corrosion resistance test method 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 Structure and classification

3.1 Structure The infusion device is mainly composed of pump tube, thermostat and connecting tube. 3.2 Classification This standard stipulates that the perfusion device is divided into A and B; the thermostat needs to be connected to the heat exchange water tank as A type, and the thermostat using ice-water mixture is B.

4 requirements

4.1 Appearance 4.1.1 It should be clean and free of foreign matter, and the blood path should be transparent or translucent.

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