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
 |
Finished shoes sole bending tester | Whats/App: +86 156 1874 6768 Web: standard-groups.com Finished shoes sole bending testeris used to test shoe stiffness/rigidity by flex shoe to c... |
 |
Squirrel Cage Method Smoke Toxicity Chamber Factory Direct | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com E-mail：info@standard-groups。com Parameters ItemSpecification Qua... |
 |
ISO 20653 Automotive Wire Harness Dust & Sand Test Equipment Supplier Factory Direct | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com Technical Parameters: Model No. STD-A STD-B STD-C Inner chambe... |
 |
High Precision Automotive Wire Label Durability Test Machine Exporter | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com Features (1) Multi-sample testing – Three samples can be tested simult... |
 |
ISO 5658 Surface Flame Spread Test Machine Exporter Industrial Use | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com Parameters Parameter CategoryDetails Dimensions 1760 × 145... |
Same products
 |
HDPE高速水冷双壁波纹管生产线 | 卖方: Shandong HUASU Plastic Technology Co.,Ltd. | 机头模具采用双流道结构、氮化磨光处理机头，偏壁调整方便快捷，保证内外层壁厚均匀和稳定成型。 最新设计密闭压力水冷冷却结构，冷却充分，多点分布真空系统，效率更高，生产速度更快。 双层在线扩口功... |
 |
PanEVAP & MVR system | 卖方: Yangzhou Panstar Heat Exchanger Equipment Co., Ltd | A multiple-effect evaporator is a device that efficiently uses steam heat to evaporate water. Wat... |
 |
PanGAP wide gap welded plate heat exchanger | 卖方: Yangzhou Panstar Heat Exchanger Equipment Co., Ltd | PanGAP wide gap welded plate heat exchangerconsists of a welded plate pack with different channel... |
 |
PanBloc welded plate heat exchanger | 卖方: Yangzhou Panstar Heat Exchanger Equipment Co., Ltd | PanBloc welded plate heat exchangeris compact and efficient, although fully welded, is totally ac... |
 |
PanBox welded plate heat exchanger | 卖方: Yangzhou Panstar Heat Exchanger Equipment Co., Ltd | PanBox welded plate heat exchangerconsists of a laser welded plate pack with optimized corrugated... |
