The UK Government is looking for businesses that can support in the supply of ventilators and ventilator components across the UK as part of our response to COVID-19.
A specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak has now been developed. This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of anesthesia and intensive care medicine professionals and medical device regulators.
Several standards are referred to within this document. In support of the efforts being made and in collaboration with MHRA, BSI has worked with international standards organizations to make these standards accessible for the purposes of organizations that are involved in the UK COVID-19 response. BSI may add additional standards as required.
Upload date: 24 March 2020
- BS EN 60601-2-24:2015 Particular requirements for the basic safety and essential performance of infusion pumps and controllers
- BS EN 794-3:1998+A2:2009 Particular requirements for emergency and transport ventilators
- ISO 10651-3:1997 Lung Ventilators for Medical Use - Emergency and Transport
- BS ISO 10651-5:2006 Gas-powered emergency resuscitators
- BS ISO 19223:2019 Lung ventilators and related equipment. Vocabulary and semantics
- BS EN ISO 80601-2-12:2020 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
Upload date: 2 April 2020
- BS ISO 80601-2-84:2018 Medical electrical equipment. Part 2-84.Particular requirements for basic safety and essential performance of emergency and transport ventilators
- BS EN 62304:2006+A1:2015 Medical device software - Software life-cycle processes
- BS EN 62366-1:2015 Part 1: Application of usability engineering to medical devices
- BS EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
- PD IEC/TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
Upload date: 7 April 2020
- BS EN ISO 60601-1-2:2015 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- BS EN ISO 17510-1:2019 Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
- BS EN ISO 15001:2011 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
- BS EN ISO 18562-1:2020 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- BS EN ISO 18562-2:2020 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: tests for emissions of particulate matter
- BS EN ISO 18562-3:2020 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)
- BS EN ISO 18562-4:2020 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
- Comparison table ISO 9001:2015/BS EN 9100:2018 and ISO 13485:2016
Upload date: 17 April 2020
- BS EN 60601-1:2006+A12:2014 Medical electrical equipment. Part 1: General rquirements for basic safety and essential performance
- BS EN 60601-1-2:2007 Medical electrical equipment. Part 1-2: General requirements for basic safety and essential performace - Collateral standard: Electromagnetic compatibility - Requirements and tests
- BS EN 60601-1-6:2010+A1:2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability
- BS EN 60601-1-8:2007+A11:2017 Medical electrical equipment. Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- ISO 80601-2-70 Medical electrical equipment. Part 1-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
- Comparison table ISO 9001:2015/IATF 16949:2016 and ISO 13485:2016
