Which products require ISO 18562 testing?

Since August 2018, all medical devices, components, or accessories containing gas pathways, where the gas can be inhaled by the user—such as ventilators, oxygen concentrators, anesthesia machines, nebulizers, breathing tubes, and respiratory masks—must provide an ISO 18562 series standard testing and assessment report when applying for FDA registration.

ISO 18562 includes the following four standards:

1. ISO 18562-1: biocompatibility evaluation of breathing gas pathways in medical devices - Part 1: Evaluation and testing within a risk management process.

2. ISO 18562-2: Biocompatibility evaluation of breathing gas pathways in medical devices - Part 2: Particle emission testing.

3. ISO 18562-3: Biocompatibility evaluation of breathing gas pathways in medical applications - Part 3: Volatile organic compounds (VOC) emission testing.

4. ISO 18562-4: Biocompatibility evaluation of breathing gas pathways in medical applications - Part 4: Extractables testing from condensates.

Products applicable for ISO 18562 include but are not limited to:

- Anesthesia machines and anesthesia workstations (including gas mixers);

- Oxygen concentrators, oxygen storage devices, and oxygen concentrators;

- Ventilators, nebulizers, sprayers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, masks, and resuscitators;

- Respiratory systems, respiratory gas monitors, respiratory monitors, breathing tubes, respiratory system filters, Y-connectors, and any respiratory accessories intended for use with such medical devices.

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