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YY 1413-2016 English PDF

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YY 1413-2016: Centrifugal blood components separation device
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Basic data

Standard ID YY 1413-2016 (YY1413-2016)
Description (Translated English) Centrifugal blood components separation device
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 10,114
Date of Issue 2016-03-23
Date of Implementation 2018-01-01
Quoted Standard GB/T 191; GB 9706.1; GB/T 9969-2008; GB/T 14710-2009; GB 18469; YY/T 0466.1; YY 0709
Regulation (derived from) Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the terms and definitions, requirements, test methods, marking, instruction manuals and packaging, transportation and storage of centrifugal blood component separation equipment (hereinafter referred to as equipment). This standard applies to the use of disposable supplies connected to the donor, can simultaneously achieve blood collection, centrifugal separation of blood components, back to the input device. This standard does not apply to the following products: - Equipment or consumables for non-centrifugal blood separation equipment, such as extrusion or membrane separation (eg, separation of membranes or membranes), - Supplies used in conjunction with this equipment Centrifugal cups, centrifugal bags and the like; - autologous blood collection equipment; - medical centrifuges; - equipment for the treatment of blood only in blood bags.

YY 1413-2016: Centrifugal blood components separation device

---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.
Centrifugal blood components separation device ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Centrifugal blood component separation equipment 2016-03-23 release 2018-01-01 implementation State Food and Drug Administration issued

Foreword

The technical content of this standard is mandatory. This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Extracorporeal Circulation Equipment Standardization Technical Committee (SAC/TC158) centralized. The drafting of this standard. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Sichuan Nangeer Biomedical Co., Ltd., Tyler Bobby Special Medical Products Trading (Shanghai) Co., Ltd. The main drafters of this standard. Wu Shaohai, He Min, Liu Xiangrong, Wang Peng, Zhang Yujie. Centrifugal blood component separation equipment

1 Scope

This standard specifies the terms and definitions of centrifugal blood component separation equipment (hereinafter referred to as equipment), requirements, test methods, signs, use Brochures and packaging, transportation, storage. This standard applies to the use of disposable supplies to connect blood donors, can simultaneously achieve blood collection, centrifugal blood composition separation, Return equipment. This standard does not apply to the following products. - equipment or consumables for non-centrifugal blood separation, such as extrusion or membrane separation (eg separation or adsorption, etc.) Or supplies; --- with the equipment used in the pipeline, centrifugal cup, centrifugal bags and other supplies annex; --- autologous blood recovery equipment; --- Medical centrifuge; --- only the blood of the blood bag to deal with the equipment.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 191 packaging and storage icon Medical electrical equipment - Part 1. General requirements for safety GB 9706.1 General specification for industrial product brochures GB/T 9969-2008 Environmental requirements and test methods for medical appliances GB/T 14710-2009 GB 18469 Whole blood and ingredients Blood quality requirements YY/T 0466.1 Symbols for use in medical device labeling and information for medical devices - Part 1. General requirements YY 0709 Medical electrical equipment - Part 1-8. Safety requirements for general requirements. General requirements Medical electrical equipment and medical care Test and guidance for alarm systems in electrical systems

3 terms and definitions

GB 18469 and GB 9706.1 and the following terms and definitions apply to this document. 3.1 Centrifugal blood component separation centrifugalseparationofthebloodcomponents According to the difference in the proportion of blood components, the use of centrifugal principle to achieve the separation of blood components. 3.2 Donor donor Blood providers can refer to blood donors or patients. 3.3 Blood component product bloodcomponentproducts Blood is collected after the separation of blood components.

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