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YY 1273-2016 English PDF

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YY 1273-2016: Roller pump for auxiliary blood purification
Status: Obsolete

YY 1273: Historical versions

Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY 1273-2016319 Add to Cart 3 days Roller pump for auxiliary blood purification Obsolete
YY/T 1273-2016179 Add to Cart 3 days Roller pump for auxiliary blood purification Valid

Similar standards

YY/T 1571   YY/T 1561   YY 1271   YY/T 1274   YY/T 1272   

Basic data

Standard ID: YY 1273-2016 (YY1273-2016)
Description (Translated English): Roller pump for auxiliary blood purification
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C45
Classification of International Standard: 11.040.40
Word Count Estimation: 8,812
Date of Issue: 2016-03-23
Date of Implementation: 2018-01-01
Quoted Standard: GB/T 191; GB 9706.1; GB/T 9969; GB/T 13074; GB/T 14710-2009; YY/T 0466.1
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 terminology and definitions, requirements, test methods, marking, instructions for use, and packaging, transport and storage of roller pumps for blood purification aids. This standard applies to the blood purification auxiliary pump as defined in 3.1. The roller pump can not be used independently for blood purification therapy. This standard does not apply to: blood perfusion equipment; blood cell separation equipment; continuous blood purification equipment; skin absorption equipment; hemodialysis device: hemodiafiltration; centrifugal pump; artificial heart lung machine rolling blood pump.

YY 1273-2016: Roller pump for auxiliary blood purification

---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.
Roller pump for auxiliary blood purification ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Blood purification auxiliary roller pump 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 release of this document The Agency does not assume responsibility for identifying 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, Guangzhou City, and medical equipment Limited company. The main drafters of this standard. He Min, Wu Shaohai, Chen Yuen, Yang Jianlong, Wang Peilian, Liu Jing. Blood purification auxiliary roller pump

1 Scope

This standard specifies the terms and definitions, requirements, test methods, signs, and use of the blood purification auxiliary rolling pump (hereinafter referred to as rolling pumps) Brochures and packaging, transportation and storage. This standard applies to the oil purification auxiliary roller pump defined in 3.1. The roller can not be used independently for blood purification. This standard does not apply to. --- blood perfusion equipment; Blood cell separation equipment --- continuous blood purification equipment; --- immune adsorption equipment; --- hemodialysis device; --- hemodiafiltration device; --- centrifugal pump; --- artificial heart-lung machine rolling blood pump.

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 rules for the use of industrial products GB/T 9969 Glacier for blood purification GB/T 13074 Environmental requirements and test methods for medical appliances GB/T 14710-2009 YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements

3 terms and definitions

The following definitions and definitions as defined in GB/T 13074 apply to this document. 3.1 Blood Purification Assist Roller Pumps rolerpumpforauxiliarybloodpurification In the blood purification treatment, with rolling to assist the blood circulation therapy of a power device.

4 requirements

4.1 normal working conditions Shall meet the manufacturer's requirements or the following conditions. a) Ambient temperature 5 ℃ ~ 40 ℃;
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