The 60601-1-2 standard is the EMC standard for the 60601 family of standards, meaning that it applies in principle to all medical electrical equipment. The full name of the standard, DIN EN 60601-1-2:2016, is: "Medical electrical equipment – Part 1-2: General requirements for the ...
10/30/2017
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
Sometimes things happen whose consequences only become truly apparent years later. Such a thing happened on May 25, 2017. EU Regulation 2017/745 entered into force. The MDR replaces the MDD (93/42/EEC) and the AIMD (90/385/EEC). ...
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. ...
page [tcb_pagination_current_page] of [tcb_pagination_total_pages]