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 ...
The last article explained some basic concepts related to isolation diagrams. In this article, we will now go through the creation of an isolation diagram step by step. 1. Establishing the System Context First, we need to determine which device and ...
The electrical safety of medical devices has already been the subject of several articles: The article "Insulation Diagrams in Medical Technology" discusses insulation diagrams in general. The article "Electrical Safety in Medical Technology" describes how electrical medical devices are classified and ...
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