Infusion Sets Positive Pressure Leakage Tester
Infusion Sets Positive Pressure Leakage Tester | ISO 8536-4, EN 1618
Infusion Sets Positive Pressure Leakage Tester – ToronMed™ ISLTPP04 is designed to evaluate the positive pressure leakage performance of infusion sets. It is also suitable for testing various catheters, blood transfusion sets, and anesthesia filters, ensuring product safety, compliance, and reliability under clinical pressure conditions.
Standards Compliance
The ToronMed™ ISLTPP04 Infusion Sets Positive Pressure Leakage Tester is designed in accordance with major international standards, including:
- ISO 8536-4 (Infusion equipment for medical use)
- EN 1618 (Catheters – Leakage testing)
Standard Configuration
- Main instrument unit
- 7-inch touchscreen interface
- Hydraulic liquid reservoir
- Integrated micro printer
Why Choose Infusion Sets Positive Pressure Leakage Tester – ToronMed™ ISLTPP04?
The Infusion Sets Positive Pressure Leakage Tester – ToronMed™ ISLTPP04 combines precision, automation, and robust safety features to deliver dependable results for infusion and catheter leakage testing. With gradient testing capability, advanced data management, and GMP-compliant security, it is trusted by medical device manufacturers, R&D facilities, and quality control laboratories worldwide.
This tester ensures that infusion sets and related medical devices meet global performance and safety requirements, making it a critical tool for protecting patient safety and ensuring regulatory compliance.
- Basic Applications
- Infusion sets
- Catheters
- Extended Applications
- Blood transfusion sets
- Anesthesia filters
- Advanced Microcomputer Control
Embedded processor with simplified interface delivers precise, efficient, and user-friendly operation. - 7-Inch HD LCD Touchscreen
Displays test data and curves in real time for clear analysis. - Gradient Test Mode
Enables identification of the critical leakage pressure value for specimens with high accuracy. - Large-Capacity Data Storage
Stores up to 100,000 test records with convenient access to historical data for review and printing. - Built-In Safety Protections
Overvoltage protection, power-off memory, and automatic shutdown for over-range pressure extend instrument life and ensure safe operation. - Data Security & Compliance
Four-level password protection and GMP-compliant software with user management, authority management, and audit trail functionality. - Automated Results & Reporting
Pass/fail judgments are automatically determined, and results can be printed directly.
Test Principle
The Infusion Sets Positive Pressure Leakage Tester applies controlled positive pressure to the infusion set or catheter system. By maintaining the preset pressure for a defined duration, the system monitors for leaks and determines whether the device meets required performance and safety criteria.
Specification | Value |
|---|---|
| Test Range | 0–600 kPa (0–87 psi, standard) Optional: 0–1.6 MPa (0–232 psi) |
| Accuracy of Pressure Sensor | ≤ 0.3% FS |
| Resolution | 0.1 kPa |
| Gas Supply Pressure | 0.4–0.7 MPa (customer-supplied) |
| Gas Supply Port | Φ8 mm PU Tubing |
| Instrument Dimensions | 310 × 370 × 150 mm |
| Reservoir Dimensions | 215 × 215 × 240 mm |
| Voltage | AC 220V 50Hz / AC 110V 60Hz |
| Net Weight | 25 kg |