Application of risk management to medical devices The third edition of ISO 14971 was published in December 2019. This article summarizes the standard and discusses the changes in the standard. Why a new edition? According to ISO, ...
10/11/2019
Have you considered functional safety for your medical device? And if not, do you have an overview of what functional safety actually is? If not, I would like to give you an introduction to the topic in this article. Because ...
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. ...
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. ...
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