Leak testing helps ensure that infusion sets do not leak during use. Leaks can lead to drug waste, poor efficacy, or even danger to patients.
The standard GB8368-2018 - Gravity Infusion Formula for One-time Use of Infusion Sets has relevant provisions for infusion sets.
Leak test. a.2 Leak test.
a.2.1. Before the start of the test, the state of the whole system is adjusted at the test temperature. a.2.2. Connect the infusion set with the air source, block other outlets, and apply an air pressure 50kpa higher than the atmospheric pressure for 15s. Inspect the infusion set for air leaks in 40 water.
a.2.3. Fill the infusion set with distilled water to remove bubbles, connect it to a vacuum device, and apply a pressure of -20kpa inside at 40 for 15s. Check to see if air is entering the infusion set.
SZF8368-C Infusion Set Leakage Positive and Negative Pressure Tester is suitable for testing infusion sets, blood transfusion sets, infusion needles, anesthesia bag filters, pipelines, catheters, quick connectors, etc., mainly used to determine the physical characteristics of medical infusion sets.
The infusion set leakage positive and negative pressure tester is an instrument used to test the leakage performance of the infusion set. Its main uses include:
Test the sealing performance of the infusion set: The tester can check the tightness of the infusion set under positive pressure or negative pressure to ensure that the liquid leakage or air ingress will not be caused by poor sealing during use, which will affect the safety of infusion.
Ensuring product quality: Used in the production process of medical devices, as a part of quality control, to ensure that each infusion set meets medical safety standards.
Compliance with industry standards and regulatory requirements: Many countries and regions have strict testing standards for medical devices, and the use of such testers can help manufacturers ensure that their products meet relevant safety and health standards.
Improve patient safety: Protect patient safety by ensuring the sealing performance of infusion sets and reducing medical accidents due to device failure.
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