Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak
This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators.
The guidance is for devices which are most likely to confer therapeutic benefit on a patient suffering with ARDS caused by SARS-CoV-2, used in the initial care of patients requiring urgent ventilation.
The UK has fulfilled the clinical need for ventilators through a combination of existing certified ventilators on the market and existing applications to the Ventilator challenge. We aren’t currently able to proceed with any new applications.
Further information from the Cabinet Office who are running the Ventilator challenge.
We are aware that there are several international groups, including the World Health Organisation (WHO), are referring to it for their own emergency ventilators.
We will continue to make our latest specification available.
There is guidance on the specification for Rapidly Manufactured CPAP System.
We have also published guidance on Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak.
The British Standards Institution have made their standards on ventilators accessible free of charge.
Last updated 28 April 2020 + show all updates
Added information that we aren’t currently able to proceed with any new applications to provide ventilators that have not already started.
Added a HTML version of the specification
Published an updated version of the specification.
Published an updated version of the specification document, and added links to other relevant guidance and standards.