Biocompatibility Testing of Respiratory Devices as per ISO 18562 – Use of Appropriate Testing and Evaluation Strategies

Due to ongoing changes in medical device standards and regulations, manufacturers of respiratory devices must plan their testing strategy in advance, perform the required tests using state-of-the-art test methods and evaluate all results in a biological risk assessment document. The ISO 18562 series of standards can be used not only for respiratory equipment – such as ventilators and breathing systems – but also for the corresponding accessories, including tubing, masks, y-connectors, oxygen hoods, etc. When there is direct contact between such devices and the patient’s body, the device must be evaluated by ISO 10993 in addition to ISO 18562. To ensure all requirements are met, close cooperation between various experts – including engineers, analytical chemists, and toxicologists – is necessary.