For certification according to IEC EN 60601-1, TÜV will generally require an insulation diagram. However, searching for the term "insulation diagram" in the basic standard 60601-1 yields no results. This article will describe what... ...
07/31/2017
Manchmal passieren Dinge, deren Auswirkungen erst Jahre später so richtig erkennbar werden. So etwas ist auch am 25.05.2017 passiert. Die EU Verordnung 2017/745 ist in Kraft getreten. Die MDR ersetzt die MDD (93/42/EWG) und die AIMD (90/385EWG). Die ...
04/23/2016
Lately, there has been a growing amount of bad news regarding the intrusion of information technology (IT) into hospitals and medical devices. After servers, routers, and cars, an anesthesia machine was also hacked. And hospital staff have ...
12/13/2015
The safety of electrical medical systems is a major issue that can affect us all. Almost every day, recalls and warnings for medical devices are published on the website of the Federal Institute for Drugs and Medical Devices (BfArM). ...
Anyone working in the medical technology sector has likely heard of the ISO 13485 standard. It deals with quality management systems for medical devices. But what exactly does this standard contain? In this blog post, I'd like to give you an overview. ...
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