YY/T 1414-2016Liquid line solenoid valve for haemodialysis equipment (English PDF)
血液透析设备液路用电磁阀技术要求
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 23, 2016
Implementation date
January 1, 2017
Scope
YY/T 1414-2016 is the English-translated version of 血液透析设备液路用电磁阀技术要求.
YY/T 1414-2016 is the Chinese pharmaceutical industry standard for the liquid line solenoid valve used in haemodialysis equipment, the electrically operated valve that opens and closes the dialysis fluid circuit.
It sets the technical requirements and the test methods for it, covering the normal working conditions declared by the manufacturer, the biological evaluation of the materials in contact with the fluid, the corrosion resistance, the tightness of the valve and its mechanical strength, the electrical properties and insulation, and the service life expressed in operating cycles.
It also gives the marking and the rules for packaging, transport and storage. Issued on 23 March 2016, it has applied since 1 January 2017.
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Document preview — YY/T 1414-2016
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 45
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 normative reference document
- 3 Terms and definitions
- 4 Requirements
- 5 Test Method
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
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 document. 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 Liquid line solenoid valve
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.2Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB 4208
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Related Standards
GB 9706.2-2003 — Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
GB/T 16886.1-2001 — Biological evaluation of medical devices - Part 1: Evaluation and testing
GB/T 16886.1-2011 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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