Custom Leakage negative pressure tester for infusion device

Produced by: Standard International Group (HK) Limited

All supplier products

Whats/App: +86 156 1874 6768

Web: standard-groups.com

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.

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

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)

(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

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