Haredata Application - Diagnostic Medical Devices
Ben Winstanley • December 11, 2019
Working with a Medical Device Manufacturer
In 2012, a leading manufacturer of portable, diagnostic medical devices approached Haredata Electronics looking for a power supply solution. The problem they had was that their current unit did not conform to the latest edition of the medical standard. The company had been using a power supply imported from the Far East and, although this had proved to be cost effective, the quality of the product fell short of the constantly evolving standards demanded of medical devices.
Medical Power Supplies IEC60601-1
Medical devices, including any external power supplies, must conform to IEC60601-1 – the general standard for medical electrical equipment. This standard was revised to the IEC60601-1 3rd Edition on 1st June 2012, after a comprehensive review of the previous standard, and it soon became clear that many of the cheaper imported power supplies could not meet these more stringent standards. Haredata Electronics were asked if they could supply a 3rd Edition medical power supply, with the required two means of patient protection (MOPP) that was certified for sale worldwide, including the EU, USA and Japan.
Having worked with Europe’s leading power supply manufacturer for over 25 years, Haredata were quickly able to identify a solution for our customer. The FRIWO GPP10 Medical is one of a range of IEC60601-1 3rd Edition power supplies, suitable for worldwide use thanks to the interchangeable plug system. We supplied all the required technical documents – data sheets, approval certificates and CB reports etc. – as well as a product sample for EMC testing. Our customer has since been reaping the benefits of using the FRIWO power supply as they expand their global sales into new markets and territories.
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