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 ...
05/13/2019
IEC 60601-1 is the standard for general requirements regarding the safety and essential performance characteristics of medical electrical equipment. Anyone involved in the development of medical electrical equipment, whether as a quality manager, project manager, or developer, should be familiar with this standard. ...
02/25/2019
Which standard must be observed for the approval of an electrical medical device? This article will explain how to determine this for the most important countries (i.e., EU, USA, and China). The article refers to the 60601 family of standards. ...
10/18/2018
We have already described the basics and the necessity of insulation diagrams for documenting electrical safety according to 60601-1 in several articles: Electrical safety in medical technology according to 60601-1 Insulation diagrams in medical technology Insulation diagrams according to 60601-1 Part 1: Basic concepts ...
At MEDtech Ingenieur, we are familiar with and use various tools in hardware development. For our own developments, and whenever we have the choice, we prefer Altium Designer for schematic and layout creation. This article describes why Altium is our preferred tool for schematics. ...
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