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, ...
Electrical fuses are essential components for the electrical safety of medical electrical equipment (ME equipment). They protect the device from incorrect operation, connection to excessively high or reversed supply voltages, and they protect the operator and patient in the event of electrical hazards. ...
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 ...
Ensuring the electrical safety of the devices we develop is a key aspect of our daily work. Much has already been written about electrical safety and insulation diagrams in other articles (Part 1 and Part 2). In this article, I would like to... ...
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. ...
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. ...
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