Tag Archives: IEC 60601-1
FAQ: Risk Management for IEC 60601-1
FAQ: Risk Management for IEC 60601-1 What you need to know about Risk Management for medical devices What is Risk Management in 60601? Risk management is a series of risk evaluations performed by the manufacturer, based on ISO 14971, which are undertaken and documented throughout the design, production and post-production process of medical equipment. The... Read More
For New Technologies – Like 3D Printers – What Product Safety Standard Applies?
Product safety compliance for equipment that falls into an established product category is straightforward. But what about new technologies – how are these products evaluated? As a case example, let’s look at 3D printers. 3D printers aren’t new, but they are just now entering the mainstream, with many more manufacturers developing new small desktop versions... Read More
