Export Leakage negative pressure tester for infusion device
Whats/App: +86 156 1874 6768
Web: standard-groups.com
Standards
The instrument is compliant with the following standards, including relevant international regulations:
(1) GB 8368-2005 – Disposable Infusion Sets for Single Use — Gravity Infusion Type, Airtightness Testing Requirements
(2) ISO 8536-4 – Sterile Syringes for Medical Use — Leakage Test Methods
(3) ISO 13485:2016 – Medical Devices — Quality Management Systems for Regulatory Compliance
(4) ASTM F2392-04 – Guide for Leak Testing of Medical Fluid Delivery Devices
Features
(1) Precision negative pted control: ensures repeatable and reliable results
(4) Safety interlocks and auto-shutoff prevent device damage
(5) Compact footprint (500×600×500 mm) suitable for labs and production lines
(6) Adjustable test time (1–16 seconds) with intuitive digital touchscreen interface
(7) Distilled water flushing system in vacuum chamber eliminates air bubbles for accurate detection
(8) Stainless steel construction for corrosion resistance and easy cleaning
Technical Parameters
| Parameter | Specification |
|---|---|
| Control Mode | Automatic (PLC) |
| Test Pressure Range | -10 kPa to -30 kPa (Adjustable) |
| Pressure Accuracy | ±0.5 kPa |
| Temperature Range | 23 ±1°C / 40 ±1°C |
| Test Time | 1–16 seconds (Adjustable) |
| Chamber Material | Medical-grade stainless steel |
| Power Supply | AC 220V ±10%, 50Hz |
| Dimensions (L×W×H) | 500 mm × 600 mm × 500 mm |
| Net Weight | 30 kg |
| Display | LED Touchscreen (Pressure/Time/Status) |
Accessories
(1) Vacuum chamber with integrated distilled water flushing system
(2) Standard connectors for syringes and infusion sets
(3) Power cable
(4) Operation manual
(5) Calibration certificate
Test Procedures
(1) Install the infusion device or syringe in the vacuum chamber connector
(2) Seal the chamber properly and ensure the distilled water flushing system is operational
(3) Set the test pressure (-10 to -30 kPa) and test time (1–16 s) on the touchscreen interface
(4) Select the desired temperature condition (23°C or 40°C)
(5) Start the automated test
(6) Monitor the pressure decay and leakage rate in real time on the display
(7) Review results and mark the device as “Qualified” or “Unqualified”
(8) Release the pressure and remove the tested device
(9) Repeat for additional samples
Maintenance Information
(1) Clean the vacuum chamber and connectors after each test to remove residues
(2) Inspect seals, connectors, and chamber surfaces for wear or damage
(3) Calibrate pressure sensors and temperature control systems regularly
(4) Store the instrument in a clean, dry, and ventilated environment
(5) Avoid excessive force or impact on the instrument to prevent damage
(6) Maintain logs for calibration, testing, and maintenance to comply with regulatory requirements
Отправить запрос, связаться с поставщиком
Другие товары поставщика
 |
Rupture strength tester | Whats/App: +86 156 1874 6768 Web: standard-groups.com Standard IEC 61730-2: Photovoltaic (PV) Module Safety Qualification – Requirements f... |
 |
Adiabatic Self - Accelerating Decomposition Temperature Tester | Whats/App: +86 156 1874 6768 Web: standard-groups.com Product Introduction This product complies with "Recommendations on the Transport of Dange... |
 |
Battery Adiabatic Heat Meter | Whats/App: +86 156 1874 6768 Web: standard-groups.com Reference Standards GB/T 36276 - 2023 *Lithium - ion Batteries for Electric Power Energy S... |
 |
Air Intake Filter Test System Manufacturer | ISO 16890 & ISO 29461 Filtration Performance Testing Equipment | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com E-mail：info@standard-groups。com Parameters ParameterUnitValue Te... |
 |
Laboratory expansion tank pressure tester | Whats/App: +86 156 1874 6768 Web: standard-groups.com The Expansion Tank Static Pressure Test Machine is a specialized system designed to evaluat... |
Похожие товары
 |
ER4047 Aluminum Mig Welding Wire | Продавец: 868776 | Hangzhou Kunli Welding Materials Co., Ltd. specializes in manufacturing reliable welding material... |
 |
ER4043 Silicon Aluminum Welding Wire | Продавец: 868776 | Hangzhou Kunli Welding Materials Co., Ltd. specializes in manufacturing high-quality welding mate... |
 |
Choosing the Right Equipment for Heavy-Duty Cleaning | Продавец: Taizhou Feike Mechanical Technology Co., Ltd. | FEIKE’s High Pressure Washer is designed for industrial cleaning, equipment maintenance, ve... |
 |
ER4043 Silicon Aluminum Welding Wire | Продавец: 868776 | Hangzhou Kunli Welding Materials Co., Ltd. offers ER4043 Silicon Aluminum Welding Wire for alumin... |
 |
Высокоскоростная экструзионная линия для производства гофрированных труб с двойными стенками из ПЭВП с водяным охлаждением | Продавец: Shandong HUASU Plastic Technology Co.,Ltd. | Формы имеют структуру с двойным каналом потока и фильерную головку, обработанную азотированием и ... |
