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) |
在线联系供应商
Other supplier products
 |
Tracking Index Tester | Get a quote： Whats/App: +86 185 0176 3615 Web: qinsun-lab.com Leakage Current Tracking Tester is designed to evaluate the tracking resistance of... |
 |
Suture Needle Elasticity and Toughness Tester | ASTM ISO Testing Machine | Get a quote： Whats/App: +86 185 0176 3615 Web: qinsun-lab.com The Elasticity and Toughness Tester for Suture Needles is a specialized device ded... |
 |
Automotive Wire Low-Temperature Winding Tester ISO 6722 | Get a quote： Whats/App: +86 185 0176 3615 Web: qinsun-lab.com Low-temperature adaptability testing of wires, cables, and electrical components. ... |
 |
45 Degree Flammability Tester | Get a quote： Whats/App: +86 185 0176 3615 Web: qinsun-lab.com Application 45 Degree Flammability Tester is used to determine the burning charac... |
 |
Infusion Apparatus Leakage Positive Pressure Tester | Get a quote： Whats/App: +86 185 0176 3615 Web: qinsun-lab.com The M102 Infusion Apparatus Leakage Positive Pressure Tester is designed to evalua... |
Same products
 |
不锈钢焊剂芯焊丝 E308T1-1 E308HT1-1 E308LT1-1 用于304不锈钢焊接的气保焊丝 | 卖方: 863048 | 产品描述 不锈钢药芯焊丝 E308T1-1 E308HT1-1 E308LT1-1，FCAW不锈钢焊丝，AWS A5.22药芯焊丝，304不锈钢焊接耗材，低碳不锈钢药芯焊丝，耐高温不锈钢焊丝，... |
 |
E317LT1-1 焊剂芯线 CO2 不锈钢焊剂含量70% 直径1.0/1.2/1.6mm OEM定制 1200℃熔点 | 卖方: 863048 | 迅卓不锈钢药心焊丝 E317LT1-1 分类： Сварочная проволока E317LT1-1 с флюсом, нержавеющая сталь, 70% содержан... |
 |
Mini Jewelry Laser Repair System – 60W to 400W Precision Welding | 卖方: Beijing JCZ Technology Co., Ltd | The Mini Jewelry Laser Welding Machineis an advanced mini laser welding system engineered for pre... |
 |
Portable Backpack Laser Cleaning Machine – Lightweight, Efficient Rust & Paint Removal | 卖方: Beijing JCZ Technology Co., Ltd | TheHCP-M SeriesBackpack Laser Cleaning Machinefeatures a compact pulsed fiber laser system, desig... |
 |
Suitcase Pulsed Laser Cleaning Machine | Ultra-Portable Handheld Fiber Laser Cleaner | 卖方: Beijing JCZ Technology Co., Ltd | The Suitcase Pulsed Laser Cleaning Machineis an ultra-portable, high-precision handheld fiber las... |
