ISO 18562 Testing

Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications 

What is it and Why is it Important?

ISO 18562 is the standard for toxicity studies in respiratory devices and components required by the regulatory bodies of the United States and European Union. The testing searches for three sources of potentially hazardous materials that are being emitted by the device and/or its components. The emission of these hazardous particles could enter the respiratory system, causing dangerous conditions for the patient.

The three areas of this standard are as follows and are all conducted at PSN:

  1. ISO 18562-2: Particles
  2. ISO 18562-3: VOCs
  3. ISO 18562-4: Leachables


In this testing, we detect and identify harmful levels of compounds and begin a safety assessment of the device on the patient. The detection of harmful levels of particles and compounds is extremely important to patient health - as they can cause irritation to the patients' respiratory tract and lungs or worse, cause damage to the patients' organs.

PSN is equipped with industry-leading equipment for qualifications of devices and the generation of data for FDA submissions. Our team of scientists and engineers are trained to isolate confounding variables and provide clear analysis to guide the commercialization of new medical devices.

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