Infusion Pumps & Drug Delivery Systems Testing
The testing of infusion pumps and drug delivery systems is a critical aspect of ensuring patient safety and regulatory compliance. Infusion pumps are medical devices designed to deliver precise amounts of medication or fluids into the body over time, often through intravenous (IV) lines. These devices play a vital role in various healthcare settings, from hospitals and clinics to home care environments. The reliability and accuracy of these systems directly impact patient outcomes and safety.
Drug delivery systems encompass a range of technologies aimed at improving medication administration efficiency and effectiveness. They include syringe pumps, continuous infusion pumps, and automated dispensing systems used in hospital pharmacies. Ensuring the robustness and precision of drug delivery is paramount to minimize errors and side effects. Testing these devices involves rigorous validation under various conditions to ensure they meet international standards.
Given the complexity and critical nature of infusion pumps and drug delivery systems, specialized testing methods are essential. These tests often involve simulating real-world conditions such as temperature variations, mechanical stress, electrical interference, and fluid flow rates. Regulatory bodies like the FDA (United States), CE marking (Europe), and ISO have established standards to guide these tests.
Our laboratory employs state-of-the-art equipment tailored for these specific tests. For instance, we use high-precision syringe pumps to mimic patient-specific dosing scenarios. We also conduct electrical safety checks to ensure compliance with IEC 60158 and ANSI/AAMI PS37 standards. Fluid flow rate testing is carried out using specialized manifolds that simulate IV lines, providing accurate data on pump performance.
In addition to mechanical and electrical tests, our lab evaluates the biocompatibility of materials used in these devices. This involves assessing potential allergens or harmful substances leaching into contact with bodily fluids. We follow ISO 10993 guidelines for biological testing, ensuring that all components are safe for patient use.
Our expertise extends to software validation and verification, which is crucial given the increasing reliance on programmable features in modern infusion pumps. This includes reviewing firmware updates to ensure they do not introduce any安全隐患
