HEV Specification Standards

The safety and reliability built into the HEV design, along with issues such as patient comfort, have been guided via specifications and guidelines issued in response to the COVID-19 pandemic and consultations with clinicians.   Due to the mechanical concept of the system and the flexibility of the software design, we are able to exceed minimum specifications in many instances.  The major guidelines which have been used are listed below:

MHRA specifications

ISO 80601-2-12

WHO COVID-19 technical Specifications for invasive and non-invasive ventilators

AAMI Emergency Use Ventilator design guidance

Clinical advice: A number of clinicians and medical engineers form part of the HEV collaboration and are advising on the implementation.