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.
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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.
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.
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5368 Kuhl Road
Erie, PA 16510
Emissions of Particulate Matter
The testing associated with the first of three sources of
potentially hazardous materials looks specifically for
particles from 0,2 μm diameter to 10 μm diameter that
are being emitted by the device and/or its components.
The emission of any particles could enter the respiratory
system via the respirable gas stream, causing dangerous
conditions for the patient.
Volatile Organic Compounds (VOCs) can be emitted from the gas pathways of respiratory medical device, including its plastic parts and accessories, adhesives and greases.
This testing program will detect any potential contamination that could be conducted to the patient, while using these life saving devices, from the polymeric compounds of the device components.
The detection of these chemicals is extremely important to devices, as VOCs can cause irritation to the patients respiratory tract and lungs or worse, cause damage to patient organs.
The testing associated with part 4 of ISO 18562 quantifies and analyzes hazardous water- soluble substances that could leach in condensate, entering into the gas pathways of the device, and transfer to the patient.
Compounds that are leached from the respiratory device are detected and identified. A safety assessment of the device on the patients is then conducted.