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.

Scroll down for more infomation

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

ISO Certified Labs

Our state-of-the-art Testing Laboratory is ISO/IEC 17025:2017 accredited and fully equipped to support all your material and product testing needs.

Our lab operates as a stand-alone service, as well as being integrated into our full spectrum of engineering services.

PSN’s experience and expertise crosses over a wide range of industries, products, and manufacturing processes, allowing our team to be a best-in-class choice to help determine and correct the risks associated with device manufacturing.

ISO 18562

In 2017, ISO 18562 was released and added to ISO 10993-1 as the standard for toxicity studies in respiratory devices and components, required by United States and European Union regulatory bodies. The standard analyzes three areas of potentially hazardous materials:

ISO 18562-2: Particles

ISO 18562-3: VOCs

ISO 18562-4: Leachables

The PSN Test Lab is equipped with industry leading equipment for qualification of devices and the generation of data for FDA submissions. At PSN, we are so much more than just a test lab. Our team of scientists and engineers are trained to isolate confounding variables and provide clear analysis to guide the commercialization of new medical devices.

Plastics Services Network (PSN)

5368 Kuhl Road
Erie, PA 16510
Phone: 814.464.0790
Fax: 814.464.0794