ISO 28620 Non-Electrically Driven Portable Infusion Device Testing
The ISO 28620 standard specifically addresses the testing of non-electrically driven portable infusion devices, which are critical in modern medical practices for delivering precise drug doses to patients. These devices must meet stringent safety and performance criteria to ensure they function reliably under various conditions without electrical power.
At Eurolab, we understand the importance of these devices in healthcare settings, where any malfunction could have severe consequences. Our expertise lies in providing comprehensive testing services that adhere strictly to ISO 28620 guidelines. This ensures compliance with international standards and helps medical device manufacturers meet regulatory requirements.
The tests conducted under this standard include mechanical durability checks, fluid path integrity assessments, volumetric accuracy evaluations, and environmental stress qualification tests. These rigorous procedures aim to identify potential weaknesses in the design and manufacturing process that could lead to adverse outcomes if not addressed early on.
For instance, during the mechanical durability test, we subject the infusion pump to repeated cycles of operation and rest to simulate real-world usage patterns. We then carefully inspect for any signs of wear or damage after each cycle. The fluid path integrity assessment involves checking seals and connectors for leaks while the device is operated under specified conditions.
Volumetric accuracy evaluations ensure that the infusion pump delivers exactly the prescribed dose, which is crucial given the precision required in drug administration. Lastly, environmental stress qualification tests expose the device to temperature extremes, humidity variations, and other challenging environments to determine its robustness against adverse conditions.
These thorough testing protocols not only help manufacturers produce safer products but also contribute significantly towards protecting patients from potential risks associated with improper operation of infusion devices. By adhering strictly to ISO 28620 guidelines, Eurolab ensures that every device tested meets the highest quality standards demanded by regulatory bodies worldwide.
Our commitment to excellence extends beyond just compliance; it involves continuous improvement and innovation in our testing methodologies. We stay updated with the latest developments in medical technology and incorporate them into our services, ensuring that we remain at the forefront of this rapidly evolving field.
Scope and Methodology
The scope of ISO 28620 Non-Electrically Driven Portable Infusion Device Testing encompasses a range of mechanical, fluidic, and functional tests designed to evaluate the safety and performance characteristics of these devices. The primary goal is to ensure that the infusion pumps function reliably under all intended conditions without electrical power.
- Mechanical Durability: This test involves subjecting the device to repeated cycles of operation and rest, simulating typical usage scenarios in hospitals or patient homes. Each cycle includes filling the pump with a specified volume of liquid, operating it until completion, then resting for a defined period before restarting.
- Fluid Path Integrity: In this test, we check the seals and connectors for leaks while the device is in operation under various pressures. This helps identify any potential weaknesses in the fluid path that could compromise patient safety.
- Volumetric Accuracy: Here, we measure the actual flow rate delivered by the pump compared to its nominal setting. Variations outside acceptable limits may indicate issues with either the hardware or software programming of the device.
- Environmental Stress Qualification: This test exposes the device to different environmental conditions such as temperature fluctuations and humidity levels to assess how well it maintains its performance characteristics under these stresses.
Eurolab Advantages
At Eurolab, we pride ourselves on delivering high-quality testing services that go above and beyond mere compliance with international standards. Our experienced team of engineers and technicians brings extensive industry knowledge to every project, ensuring accurate and reliable test results.
- Expertise in Regulatory Compliance: With deep understanding of ISO 28620 requirements, our experts ensure that all tests are conducted according to the latest guidelines. This guarantees that your products meet not only current regulations but also anticipate future changes.
- State-of-the-Art Facilities: Our laboratory is equipped with advanced instrumentation and equipment necessary for performing precise measurements and evaluations. This ensures accurate data collection during all stages of testing.
- Comprehensive Reporting: Besides providing detailed reports highlighting any issues found, we offer recommendations on how to address these problems effectively. This support helps manufacturers refine their designs continuously, enhancing product quality over time.
- Global Recognition: Eurolab is accredited by major certification bodies globally, including ISO/IEC 17025, ensuring the highest level of credibility for our test results.
