Medical devices are often vital for a patient’s well-being and must therefore be safe and should definitely not worsen their condition. However, there is a high risk of particulate contamination for intravenous and infusion medical devices that can cause health issues such as inflammation, irritation or even blood clots.
Several factors determine the level of risk a particle presents, with particle size, shape, and composition determining the associated health risks. Once found, particles can be analysed using automated microscopy, computational counting methods, and surface analysis of their physical, topographical, and morphological properties.
According to international standards, these analyses should be performed using an, at minimum, ISO Class N5 certified laboratory to minimise potential contamination. Likewise, it is necessary to conduct these analyses with the utmost precision and concentration.
SAXOCON offers a tailor-made analysis for your medical devices with a clean ISO Class N2 laboratory – which is an even higher standard than the minimum required ISO Class N5. We conduct all required tests following ISO 8536-4, USP 788, and other relevant guidelines. Furthermore, SAXOCON conducts a toxicity analysis of any particles found in your products.
By filling out the form below, you can download our white paper about medical devices and particulates and the consequences for your testing and manufacturing processes.