Infusion device Leakage negative pressure tester | ASTM ISO Testing Machine
Get a quote：
Whats/App: +86 185 0176 3615
Web: qinsun-lab.com
The Infusion Device Leakage Negative Pressure Tester is designed to evaluate the airtightness of syringes, infusion sets, and related medical devices under negative pressure. The instrument applies precise vacuum conditions to detect leaks, ensuring the integrity of medical devices for patient safety. It is suitable for laboratory testing, production quality control, research and development, and regulatory certification.
Application
The tester is suitable for leakage testing of medical infusion devices in the following industries and products:
(1) Medical Quality Control: Ensures syringes, infusion sets, and other injection devices meet strict leakage standards to protect patient safety.
(2) Pharmaceutical Manufacturing: Validates packaging and device integrity for sterile medical products.
(3) Research & Development: Supports design validation, accelerated aging, and product optimization of infusion devices.
(4) Certification & Regulatory Testing: Enables compliance with national and international medical device standards and regulatory requirements.
(5) Third-Party Testing Laboratories: Provides standardized, repeatable leakage testing for medical device certification.
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
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) |
Send product request
Other supplier products
 |
Low-Load Wear Testing Machine | Get a quote： Whats/App: +86 185 0176 3615 Web: qinsun-lab.com Application The Low-Load Wear Testing Machine is widely used in applications wher... |
 |
Flooring material combustion testing apparatus | Get a quote： Whats/App: +86 185 0176 3615 Web: qinsun-lab.com The GB/T11785 flooring material combustion test apparatus is suitable for various ... |
 |
Wool Fineness Analyzer | Get a quote： Whats/App: +86 185 0176 3615 Web: qinsun-lab.com The Wool Fineness Analyzer measures wool fiber fineness using the airflow method. ... |
 |
Automobile Wire Cross-linking Test Device SAE J1128-2005 | Get a quote： Whats/App: +86 185 0176 3615 Web: qinsun-lab.com The Automobile Wire Cross-linking Test Device is designed to evaluate the cross-li... |
 |
4-station Leather Rubbing Color Fastness Tester | Get a quote： Whats/App: +86 185 0176 3615 Web: qinsun-lab.com Email: serving@qinsun-lab。com Applicable Standards The tester adheres to global ... |
Same products
 |
Choosing the Right Equipment for Heavy-Duty Cleaning | Seller: Taizhou Feike Mechanical Technology Co., Ltd. | FEIKE’s High Pressure Washer is designed for industrial cleaning, equipment maintenance, ve... |
 |
ER4043 Silicon Aluminum Welding Wire | Seller: 868776 | Hangzhou Kunli Welding Materials Co., Ltd. offers ER4043 Silicon Aluminum Welding Wire for alumin... |
 |
HDPE High Speed Water Cooled Double Wall Corrugated Pipe Extrusion Line | Seller: Shandong HUASU Plastic Technology Co.,Ltd. | The molds adopt the double flow channel structure and nitriding polishing processed die head. Thi... |
 |
PanEVAP & MVR system | Seller: 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 | Seller: Yangzhou Panstar Heat Exchanger Equipment Co., Ltd | PanGAP wide gap welded plate heat exchangerconsists of a welded plate pack with different channel... |
