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
Send product request
Other supplier products
 |
Pinhole Tester | Whats/App: +86 156 1874 6768 Web: standard-groups.com The pinhole tester for aluminum foil is a device specifically used to detect micro - pinhol... |
 |
Coatings Shear Fatigue Test device | Whats/App: +86 156 1874 6768 Web: standard-groups.com Standard YY/T 0988.13-2017 (China): Specifies shear fatigue testing protocols for coatings... |
 |
Oxidizing Solids Tester | Conforms to UN Recommendations on the Transport of Dangerous Goods - Manual of Tests and Criteria 34.4.1 Test O.1: Test for oxidizing solids, 34.4.... |
 |
Molten Metal Splash Resistance Test Equipment | Product Introduction： Projections of molten metal drops at a point on a vertical oriented test specimen and measurement of the number of the drops... |
 |
Vertical low temperature cold resistance testing machine | Luggage rod reciprocating testing machine for luggage rod reciprocating fatigue test. In the test, the specimen will be stretched to test the gap g... |
Same products
 |
Mini Jewelry Laser Welding Machine | Seller: Beijing JCZ Technology Co., Ltd | The Mini Jewelry Laser Welding Machineis an advanced mini laser welding system engineered for pre... |
 |
Pulse Laser Cleaner | Handheld Solution for Precision Surface Cleaning for Rust & Coating | Seller: Beijing JCZ Technology Co., Ltd | Looking for an efficient and eco-friendly laser cleaning machine? The HCP Series Pulse Laser Clea... |
 |
Mini Type Laser Marking & Engraving Machine – Fiber & UV Laser Options for Precise Marking | Seller: Beijing JCZ Technology Co., Ltd | This compact, Mini Type fiber laser marking machineis perfectly suited for small businesses, work... |
 |
Large Enclosed Laser Marking & Engraving Machine for Industrial Use | Seller: Beijing JCZ Technology Co., Ltd | The Large Closed Laser Marking Machineis a high-performance engraving solution designed for indus... |
 |
Axial force wire guide apparatus | Seller: Standard International Group (HK) Limited | Whats/App: +86 156 1874 6768 Web: standard-groups.com Standards YYT0807 - 2010 :Standard Guide... |
