We often give little thought to terms we use frequently. Therefore, it's helpful to clarify terminology and maintain a glossary within the project. This should also include the terminology used to describe patient-related connections. We ...
Electrical fuses are essential components for the electrical safety of medical electrical equipment (ME equipment). They protect the device from incorrect operation, connection to excessively high or reversed supply voltages, and they protect the operator and patient in the event of electrical hazards. ...
10/22/2019
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. ...
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... ...
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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