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Medical device negative pressure tester
Product Definition: Medical device vacuum test instrument is a professional equipment used to detect leakage at the piston or seal ring during negative pressure extraction and the separation of the piston from the core rod of medical instruments. It is widely used in the quality control of products such as syringes, infusion pumps, catheters, etc., to ensure no leakage during clinical use, thereby guaranteeing patient safety.
Test Standards: Follows national standards and international specifications such as GB 15810-2019, YY/T 0573.4, ISO 7886-1.
Working Principle:
Connect the syringe tip to the device and suck part of the water inside the syringe. Apply negative pressure through the tip to check for leakage at the syringe piston and seal ring, and determine whether the piston has separated from the core rod. The instrument simulates the suction situation of medical instruments in actual use. If there is a sealing defect in the product, external air will seep in, causing the pressure to rise. High-precision sensors monitor pressure changes in real time and determine whether there is a leakage based on the standard.
Main Configuration:
Vacuum Pump System: Provides stable negative pressure, ranging from 0 to -90kPa.
Pressure Sensor System: Precision up to 0.1 level, resolution of 0.01kPa, capable of capturing minor leaks.
Clamping System: Adapts to syringes with different specifications ranging from 0.1ml to 200ml, ensuring a sealed connection.
Control System: Equipped with a 7-inch color touch screen, supporting both Chinese and English interfaces, enabling one-button automatic testing.
Data Management: Supports USB flash drive export and mini-printer output, in line with GMP data requirements.
Application Fields:
Manufacturers: Pre-delivery inspection or full inspection to ensure product quality.
Testing Institutions: Third-party authoritative testing, issuing compliance reports.
Research Units: Development and verification of new materials and new structures for syringes.
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