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    BSI supports government’s RMVS initiative

    25 March 2020

    BSI is in full support of the government’s Rapidly Manufactured Ventilator System (RMVS) initiative and we have directly engaged in the approach as it is defined. We are supporting the manufacturing initiative by working with the Medicines and Healthcare products Regulatory Agency (MHRA) to supply technical expertise and potentially manufacturing site audits. In addition, we have allowed access to some key technical relevant standards, with more to follow.  BSI will focus on these efforts as a priority to help support UK patient access to critical technology as we all work to fight against COVID-19.

    The following standards are now available to access: 

    • 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 80601-2-84:2018 Medical electrical equipment. Part 2-84. Particular requirements for basic safety and essential performance of emergency and transport ventilators
    • BS ISO 10651-5:2006 Gas-powered emergency resuscitators
    • BS ISO 19223:2019 Lung ventilators and related equipment. Vocabulary and semantics

    These standards can be downloaded here

     

    ENDS