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
在线联系供应商
Other supplier products
 |
Multi-function Scratcher | Whats/App: +86 156 1874 6768 Web: standard-groups.com Application It is suitable for testing automotive interior materials, plastics, rubber, le... |
 |
Medical Suture Line Diameter Tester | Whats/App: +86 156 1874 6768 Web: standard-groups.com Applications Quality Control: The medical suture thread diameter tester plays a crucial ro... |
 |
ISO certified Mechanical load testing machine for photovoltaic modules | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com The Mechanical Load Testing Machine is a precision instrument designed to eva... |
 |
Aluminum Foil Pinhole Detector for lab use | Whats/App: +86 156 1874 6768 Web: standard-groups.com Standards - YBB00152002 - 2015 Pharmaceutical Aluminum Foil - GB/T 3198 - 2010 Aluminum a... |
 |
Explosion simulation testing system for gases | Whats/App: +86 156 1874 6768 Web: standard-groups.com Application The Gas Explosion Pressure Test Apparatus is suitable for: Measurement of max... |
Same products
 |
China factory electrode TGYS125 for power station Selection of advanced | 卖方: DONGFANG YOYIK (DEYANG) ENGNIEERING CO; LTD | "China factory electrode TGYS125 for power station Selection of advanced technology, absolutely f... |
 |
Laser Chuck | 卖方: 00000 | Laser Chuck Introduce foreign advanced technology and management concept, High precision pro... |
 |
Power Pallet Jack For Sale | 卖方: Jinan Hulk Machinery Co., Ltd | Power Pallet Jack For Sale Electric Pallet Truck For Sale As a supplier of power pallet jac... |
 |
Multi Directional Forklift For Sale | 卖方: Jinan Hulk Machinery Co., Ltd | Multi Directional Forklift For Sale Multi Directional Forklift For Sale As a supplier of mu... |
 |
Narrow Aisle Forklift For Sale | 卖方: Jinan Hulk Machinery Co., Ltd | Narrow Aisle Forklift For Sale Narrow Aisle Forklift For Sale As a supplier of , we provide... |
