Infusion Apparatus Leakage Positive Pressure Tester
The M102 Infusion Apparatus Leakage Positive Pressure Tester is designed to evaluate the airtightness and sealing performance of medical injection syringes and infusion apparatus. It provides precise measurement of positive pressure integrity, ensuring that medical devices meet required safety standards. This instrument is widely used in laboratories, production quality control, and third-party certification testing.
Application
M102 Infusion apparatus leakage positive pressure tester, Itis suitable for the measurement of positive pressure airtight of medical infusion apparatus, blood transfusion devices, infusion needles, anesthesia bag filters, pipelines, conduits, quick joints, and etc. It can accurately measure whether the sealing performance of injection syringe meets the specified requirements.
It is applicable to the performance verification of new products, quality control of the production department, and the of material properties for the third-party testing organization, the product performance verification laboratory, and the quality and technical supervisiondepartment, etc.
The M102 tester is suitable for testing the positive pressure airtightness of medical devices in the following industries and products:
(1) Medical Devices: injection syringes, infusion sets, anesthesia bag filters — verification of sealing integrity under positive pressure
(2) Blood Transfusion Equipment: transfusion devices, infusion needles — assessment of airtightness to prevent leakage
(3) Pipelines and Conduits: medical tubing, quick joints, and connectors — evaluation of fluid-tight connections
(4) Research and Development: new infusion device prototypes, design optimization for airtight performance
(5) Quality Control Laboratories: production inspection of medical infusion devices to ensure compliance with standards
(6) Certification and Regulatory Testing: third-party laboratories performing performance verification for national and international medical device standards
Standards
The instrument complies with the following standards, including relevant international regulations:
(1) GB 8368-2005 – Disposable Infusion Sets for Single Use — Gravity Infusion Type, including airtightness requirements
(2) ISO 8536-4:2010 – Infusion equipment for medical use — Part 4: Infusion sets for single use, including leak testing methods
(3) ISO 13485:2016 – Medical devices — Quality management systems — Requirements for regulatory purposes (applies to testing and QC of infusion devices)
(4) ASTM F2392-04 – Standard Guide for Leak Testing of Medical Fluid Delivery Devices
Features
(1) Touch-tone control panel with LED digital display for easy operation
(2) Adjustable test pressure range: 0–100 kPa, with ≤ ±2.5% reading error
(3) Flexible test time setting (1–16 s) to meet various requirements
(4) Compact and portable design, suitable for laboratory or production line installation
(5) Automatic operation mode reduces manual intervention
(6) Accurate measurement ensures compliance with medical device safety standards
Technical Parameters
| Item | Specification |
|---|---|
| Control Mode | Automatic |
| Test Pressure Range | 0–100 kPa |
| Pressure Accuracy | ±0.5 kPa |
| Test Time | 1–16 s (adjustable) |
| Weight | 30 kg |
| Power Supply | AC 220 V, 50 Hz |
| Appearance Size | 40 cm × 45 cm × 45 cm |
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