VDE|DKE now offers free advice on standardization requirements which are essential for the safety of medical devices
The aim is to support non-sectoral companies in the rapid and reliable production of safe medical devices during the Covid 19 pandemic
Within 48 hours, manufacturers of medical devices will now receive free advice from the experts at VDE|DKE on the implementation of safety requirements. "Although every manufacturer in the medical technology sector should know which safety requirements are indispensable for individual medical devices, this cannot be assumed for career changers, for example from the automotive industry or mechanical engineering," explains Dr. Klaus Neuder, an expert at the VDE-backed standards organization DKE Deutsche Kommission Elektrotechnik Elektronik Informationstechnik in DIN and VDE (VDE|DKE). Safety standards, such as IEC 60601-1 (VDE 0750-1) Medical Electrical Equipment; Part 1: General requirements for safety, including the essential performance characteristics, are not easy to read and understand for those not familiar with the field. For this reason, the German national standards committee for medical devices now offers free answers to specific technical questions on medical device requirements. "Our goal is to provide fast and reliable support for lateral entrants in the provision of medical devices," says Neuder. "The technical experts will work closely with the relevant committee at DIN, particularly on risk management issues", Neuder adds.
Do not override safety requirements
In order to increase the supply capacity in hospitals and medical practices to cope with the COVID 19 pandemic, the demand for medical devices is increasing in many areas. Prototypes for ventilators, patient positioning systems, protective masks and clothing are needed as well as other medical devices and their accessories (e.g. tube systems). In the fight against the corona pandemic, many companies from the electrical and automotive industries as well as mechanical engineering converted their production to the urgently needed medical devices. However, even in times of crisis, even with special approvals, the safety requirements must not be overridden in the essential points. Free advice on the application of the safety-relevant standards is the third element of VDE's efforts to combat the corona pandemic. In addition to the free VDE check for medical devices and protective equipment and the free provision of the relevant standards in the medical device sector, support in implementation is now to follow.
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