Infusion Device Leakage Tester Manufacturer
Get a quote：
Whats/App: +86 156 1874 6768
Web: standard-groups.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
Features
(1) Precision negative pressure testing: -10 to -30 kPa with ±0.5 kPa accuracy
(2) Dual-temperature testing: 23 ±1°C and 40 ±1°C to simulate real-world and accelerated aging conditions
(3) PLC-driven automated 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
Отправить запрос, связаться с поставщиком
Другие товары поставщика
 |
Automotive seat frame durability tester | Whats/App: +86 156 1874 6768 Web: standard-groups.com The Automotive Seat Frame Durability Tester is a dedicated impact testing system used to ev... |
 |
Micro Controll Constant-Speed Friction Plate Tester | Whats/App: +86 156 1874 6768 Web: standard-groups.com A friction and wear testing machine is a device composed of a test force loading system, a ... |
 |
BS 476 non-combustibility test | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com This machine is designed and manfacture according to ISO 1182 .Furnace temper... |
 |
AATCC Rotary Crockmeter | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com The Rotary Rubbing Color Fastness Tester, also known as a Crockmeter, is wide... |
 |
EN ISO 20344 water vapour permeability tester | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com The Leather Water Vapor Permeability Tester measures the ability of leather a... |
Похожие товары
 |
Laser Chuck | Продавец: 00000 | Laser Chuck Introduce foreign advanced technology and management concept, High precision pro... |
 |
Power Pallet Jack For Sale | Продавец: 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 | Продавец: 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 | Продавец: Jinan Hulk Machinery Co., Ltd | Narrow Aisle Forklift For Sale Narrow Aisle Forklift For Sale As a supplier of , we provide... |
 |
Electric Order Picker Supplier | Продавец: Jinan Hulk Machinery Co., Ltd | Electric Order Picker Supplier Electric Order Picker Supplier As an supplier, we offer a co... |
