ISO 80369-20 Medical Small Bore Connector Test Equipment

ISO 80369-20 Medical Small Bore Connector Test Equipment

The ISO 80369-20 Medical Small Bore Connector Test Equipment is a comprehensive test system designed to evaluate the performance of small-bore connectors used in medical applications. It supports Annex B (pressure decay / subatmospheric-pressure air leakage) and Annex C (positive-pressure liquid leakage) test methods, and includes the Connector Assembly Device for Annexes B through I of ISO 80369-20 and ISO 18250-1.

Testing Principle

The system applies controlled pressure to the connector assembly and monitors for leakage using high-accuracy sensors. It can perform pressure decay tests and positive-pressure liquid leakage tests. The equipment also includes a Connector Assembly Device that applies precise force and torque simultaneously, as required for multiple annexes of the standard.

KingPo Factory Advantages

KingPo is an ISO 9001, ISO 14001, ISO 45001 and CE certified manufacturer, also holding SGS, PSE and RoHS certifications. We specialize in medical device testing equipment and have supplied ISO 80369-20 test systems to manufacturers and certification laboratories worldwide. Each unit undergoes rigorous calibration and is delivered with complete documentation, on-site installation guidance, a full one-year warranty and lifetime technical support from our Dongguan facility.

Professional Construction & Technical Precision

Key features include:

• Compliance with ISO 80369-20 Annex B and Annex C requirements for liquid leakage testing
• Advanced digital control system for precise pressure regulation
• Dual testing capability for both pressure testing and positive-pressure testing
• High-accuracy sensors for reliable leakage detection
• Support for Connector Assembly Device (Annexes B–I)
• Robust construction for long-term durability in medical device testing environments

These elements ensure the tester delivers consistent, repeatable results while meeting international medical connector safety standards.

Technical Parameters

The ISO 80369-20 Medical Small Bore Connector Test Equipment is used to verify the leakage performance of small-bore medical connectors during product development, production quality control, and third-party certification. It helps manufacturers ensure connectors maintain liquid integrity under specified pressure conditions, supporting patient safety and regulatory compliance.

Procurement Benefits

• Precision Testing: Accurately measures performance metrics like leakage (pressure decay or liquid leakage), stress resistance, and dimensional compliance per ISO 80369-20 Annexes B-I.
• Versatility: Suitable for testing connectors across various ISO 80369 standards, including ISO 80369-2 (respiratory), ISO 80369-3 (enteral), ISO 80369-5 (limb cuff), and ISO 80369-7 (intravascular/hypodermic).
• Regulatory Compliance: Supports compliance with FDA, CE, and other global regulations by adhering to ISO 80369-20 test methods.
• User-Friendly Design: Compact, durable, and requires no external power or compressed air, ensuring ease of use in laboratory settings.
• High Throughput: Semi-automatic testing capabilities increase efficiency, reducing test times while maintaining traceability and accuracy

Applications

• Small-bore Medical Connectors – Leakage performance verification
• Intravascular and Hypodermic Devices – Pressure and positive-pressure testing
• Medical Device Manufacturers – Design validation and production quality control
• Certification Laboratories – Compliance testing according to ISO 80369-20 Annex B and C
• R&D Departments – Optimization of connector sealing performance

Operating Instructions for ISO 80369-20 Subatmospheric-pressure Air Leakage Tester.pdf