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
 |
Vehicle-Level Temperature Humidity Test Chamber Manufacturer | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com Standards GB/T 2423.1 Environmental Testing of Electrical and Electronic Pro... |
 |
Intelligent Sample Cutting Machine | Whats/App: +86 156 1874 6768 Web: standard-groups.com The Intelligent Sample Cutting Machine is a high-efficiency automated cutting device integr... |
 |
Buy ISO1716 mineral wool heat resistance machine | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com The thermal insulation rock wool thermal load test device is a test device de... |
 |
Dental Implants Static Torsion Testing Machine | Whats/App: +86 156 1874 6768 Web: standard-groups.com Standard ISO 13498: Specifies static torsion testing protocols for dental implants, includ... |
 |
Automatic Reaction Calorimeter | Process Safety & Heat Release Analysis | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com Standards (1)GB 51283-2020: Fire Protection Standard for Engineering Design ... |
