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YY/T 1414-2016: Liquid line solenoid valve for haemodialysis equipment
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1414-2016 | English | 159 |
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Liquid line solenoid valve for haemodialysis equipment
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YY/T 1414-2016
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PDF similar to YY/T 1414-2016
Standard similar to YY/T 1414-2016 YY/T 1561 YY 1271 YY/T 1457 YY 1413 YY 1412 Basic data | Standard ID | YY/T 1414-2016 (YY/T1414-2016) | | Description (Translated English) | Liquid line solenoid valve for haemodialysis equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 8,882 | | Date of Issue | 2016-03-23 | | Date of Implementation | 2017-01-01 | | 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 | YY/T 1414-2016: Liquid line solenoid valve for haemodialysis equipment---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.
Liquid line solenoid valve for haemodialysis equipment
ICS 11.040.40
C45
People's Republic of China Pharmaceutical Industry Standard
Technical requirements for solenoid valve for liquid circuit of hemodialysis equipment
2016-03-23 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface III
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 Requirements 1
5 Test Method 2
Foreword
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. Chongqing Shan Shan Technology Co., Ltd., the State Food and Drug Administration Guangzhou medical equipment quality supervision and inspection
center.
The main drafters of this standard. Song Union Chun, Chen Jiaye, Ren Yingxiang, Yang Lifeng.
Technical requirements for solenoid valve for liquid circuit of hemodialysis equipment
1 Scope
This standard specifies the biological evaluation, mechanical properties, electrical properties, corrosion resistance and life of the solenoid valve for hemodialysis equipment
And other technical requirements.
This standard applies to the hemodialysis equipment, the valve body and the dialysate or reverse osmosis direct contact with the solenoid valve (hereinafter referred to as "solenoid valve"),
Does not apply to the valve body and liquid non-contact solenoid valve.
Note. This standard applies to hemodialysis equipment manufacturers in the procurement, research and development, production, use the process of quality control.
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 4208 enclosure protection class (IP code)
GB 9706.2 Medical electrical equipment - Part 2-16. Particular requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration devices
Blood purification terminology GB 13074-2009
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management
3 terms and definitions
GB 9706.2 and GB 13074-2009 and the following terms and definitions apply to this document.
3.1
Used in hemodialysis equipment, the control of hemodialysis of the liquid circuit open and close the electric valve device.
4 requirements
4.1 normal working conditions of the equipment
Shall meet the following conditions or according to the manufacturer's regulations.
a) Ambient temperature. 10 ° C to 70 ° C;
b) relative humidity. ≤ 80%;
c) Atmospheric pressure. 86kPa ~ 106kPa.
4.2 Biological evaluation
Biology evaluation according to GB/T 16886.1.
4.3 Corrosion resistance
The material of the solenoid valve in contact with the liquid shall be capable of withstanding the continuous contact of the various liquids (except reverse osmosis water) that may be contacted by the hemodialysis apparatus
Sexual erosion, non-metallic parts should be no color, deformation, cracking and other phenomena, the metal part of the phenomenon should be no corrosion and rust.
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