The safety concept is one of the important concept documents we create during product development. It describes why a device is safe and how safety is ensured in the event of a malfunction. Various aspects are considered, such as mechanical safety. ...
As an engineering service provider in the medical technology sector, we cannot avoid working with physiological signals such as ECGs. We often want to take a closer look at how these signals affect a particular circuit. To simulate our circuits, we use ...
Ensuring the electrical safety of the devices we develop is a key aspect of our daily work. Much has already been written about electrical safety and insulation diagrams in other articles (Part 1 and Part 2). In this article, I would like to... ...
The daily work of a physician is unimaginable today without computer systems. Therefore, it is all the more important that these systems offer high usability, reliability, and availability. Graphical user interfaces can simplify the operation of medical devices. This is achieved ...
DIN 60601-1 defines defibrillation-protected applied parts (usually also referred to as defibrillation-resistant). Applied parts must be classified as described in other articles (e.g., here). For some applied parts, standards (e.g., DIN 60601-2-27) provide further specifications. ...
06/25/2019
Failure Mode and Effects Analysis (FMEA) is a risk management method. ISO 14971 states: "Failure Mode and Effects Analysis (FMEA) and the analysis of failure modes and effects ...
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