Which Products Require ISO 18562:2024 Testing?

The ISO 18562 series of standards apply to all medical devices, components, or accessories containing tubing that come into indirect contact with patients. Common medical device products include:

- Respirators

- Respiratory systems

- Anesthesia workstations (including gas mixers)

- Oxygen generators

- Nebulizers

- Medical humidifiers

- Oxygen protection devices

- Oxygen concentrators

- Low-pressure hoses

- Heat and moisture exchangers

- Respiratory gas monitors

- Respiratory monitors

- Respiratory masks

- Ventilators

- Breathing tubes

- Respiratory system filters and Y-connectors

- Any similar medical device accessories used in a similar manner

Additionally, the inner chambers of pediatric incubators, mattresses, oxygen mask inner surfaces, etc., are also considered part of the breathing circuit.

These circuits are designed to provide respiratory care or substance supply to patients through the airway in various environments.

The ISO 18562 series standards do not cover device surfaces that come into direct contact with patients, whose biological evaluation should follow the ISO 10993 series of standards. Furthermore, any biological hazards caused by mechanical failure, contamination of the gas source in gas supplies, etc., are not covered by this standard.