Medical devices

Respiratory medical devices

Among the many medical devices, we find the respiratory medical device family. This sub-family includes all medical devices used to deliver respiratory gas to the patient. Examples include masks, insufflators and medical nebulizers.

To guarantee patient health, the quantities of respiratory gases insufflated are strictly regulated. Similarly, the materials used in the manufacture of respiratory medical devices must not represent any risk to the patient's health. This is the background to ISO 18562. This standard sets a framework for the threshold quantities of particles and Volatile Organic Substances (VOSs) that a respiratory medical device can release without risking harm to the patient's health.

In 2017, the European Union decided to make testing to quantify the concentrations of particles and VOSs emitted mandatory for any development of a new respiratory medical device representing a potential risk.

In our laboratories based in the South of France, we offer to carry out these tests in order to define together the feasibility of your project to develop a new respiratory medical device.