Catherine Macleod from element has shared what they are doing:
London, UK - April 2, 2020 - Element Materials Technology (Element) is lending its support to the national drive to increase ventilator production in response to the NHS' urgent demand to treat coronavirus patients in the UK.
Element has developed a testing regime to cover the electromagnetic compatibility (EMC) and basic safety requirements for a Rapidly Manufactured Ventilator System (RMVS) prototype being developed by a number of manufacturers and consortia. Before new devices can be categorized as ‘safe' for use in medical working environments and brought to market, it is necessary to determine if a device can perform safely and provide its essential performance without causing harm and/or electromagnetic disturbances in its appropriate operating environment. This is typically achieved by testing to applicable medical safety standards.
Safety test plans drawn up by Element's Advisory Services team based in Malvern are being used to perform the testing from its product qualification testing (PQT) laboratory in Hitchin. Element also provided EMC test plans to manufacturers who will carry out the initial phase of testing, while phase two testing will be carried out by Element from a number of its PQT facilities.
Mark Heaven, Divisional Director Global Aerospace PQT at Element said: "We are delighted to be able to offer our expertise, free of charge, to support the national effort to fight COVID-19, and are already in discussions with other medical device manufacturers to carry out EMC and safety testing on their RMVS prototypes this week. Element hopes to continue to offer our integral safety conformity services throughout this period of high demand for ventilators."
Element Hitchin is one of our safety testing centres of excellence, with UKAS accreditation to BS EN ISO/IEC 17025:2017. Our areas of technical expertise at Element Hitchin include Medical Testing & Regulatory Affairs, Safety Testing and Certifications & Approvals. We work with manufacturers of electrical medical devices; are approved to ISO 9001:2015, and typically provide medical regulatory testing and test reports to European EN 60601 series of standards and American pre-market authorizations the 510(k) route, which are the core standards/procedures for medical product verification.