YY/T 1414-2016 in English
VALIDLiquid line solenoid valve for haemodialysis equipment
- Issued on:2016-03-23
- Implemented on:2017-01-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$127.00
本标准适用于血液透析设备内部，阀体与透析液或反渗水直接接触的电磁阀。
本标准规定了血液透析设备液路用电磁阀的生物学评价、机械性能、电气性能、耐腐蚀性能及寿命等方面的技术要求。
本标准不适用于阀体与液体非接触式的电磁阀。
Introduction
Analysis of core requirements of the standard
| Technical dimensions | Key indicators | Test methods |
|---|---|---|
| Sealing performance | Positive pressure 300kPa/negative pressure 93.3kPaNo leakage | 5.4.1/5.4.2 Pressure test method |
| Electrical safety | Insulation resistance ≥20MΩ | 5.7.2 Megaohm test |
| Durability | Opening and closing cycles ≥Manufacturer nominal value | 5.9 Life Test Device |
Key Technical Notes
The standard clearly stipulates the liquid isolation structure of the solenoid valve: moving parts such as the moving iron core and spring must be completely physically isolated from the dialysate (Clause 4.6). This requirement stems from the dual risks of chemical corrosion and biological contamination in hemodialysis equipment.
Clinical Application Cases
When using a non-isolated solenoid valve, a medical accident occurred in the hemodialysis center of a tertiary hospital, where the spring rusted and the valve body was stuck. After improvements according to this standard, the solenoid valve with a fully sealed structure has been used continuously for 2 years without any failure.
Analysis of Standard Evolution
Compared with previous industry practices, this standard includes response time (Clause 4.8) as a mandatory test item for the first time, requiring that the opening/closing time must be quantitatively measured and comply with the manufacturer's declared value. This indicator directly affects the accuracy of dialysate ratio.
Implementation Recommendations
- The procurement process should require suppliers to provide a 168-hour corrosion test report that complies with Clause 5.3.
- Insulation resistance (Clause 4.7.2) must be tested regularly during the maintenance phase, and it is recommended that it be measured every 6 months.
- For life testing (Clause 5.9), it is recommended to use actual dialysate rather than pure water, which is more in line with clinical conditions.
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