The V-model is a development process model that was originally used for government projects (e.g., armaments). To this day, it is still anchored in many people’s minds and in standards for projects in regulated environments (e.g., medical technology, banks). This leads to disputes in teams that prefer agile development processes. This article helps to resolve…
DetailsMedical devices must comply with the legal requirements for functional safety. Unfortunately, the relevant standards and laws for medical devices do not define or use the term “functional safety.” This article provides clarity.
DetailsIn May 2016, the German version of IEC 60601-1-2:2014 (Edition 4) was published as DIN EN 60601-1-2:2016 with the title “Electromagnetic disturbances – Requirements and tests.” At the end of 2020, a new version of this “EMC standard” – modified by Amendment 1 and called Edition 4.1 – was published.
DetailsThe Machinery Directive (2006/42/EC) is generally applicable to machines of all types. However, the directive can also be relevant for medical device manufacturers: both the MDR and the IVDR refer to it. If the Machinery Directive comes into play, requirements that go beyond those of the MDR and IVDR apply. Therefore, this article will give you an…
DetailsIEC 60601-1 describes essential performance as performance necessary to achieve freedom from unacceptable risk. This article aims to explain what the standard means by that and how this essential performance differs from basic safety. The article also addresses the IEC 60601-1/AMD1/ISH1:2021 INTERPRETATION SHEET 1.
DetailsIEC 61010-2-101 is a harmonized standard for in vitro diagnostics (IVD). IVD manufacturers can use IEC 61010-2-101 to demonstrate conformity with the general safety and performance requirements of the IVD Regulation (IVDR).
IEC 60601-1 defines a PESS, a Programmable Electronic Subsystem, as a system based on one or more central processing units, including their software and interfaces. The standard does not reveal what it means by system; in this context, it is a medical device component. For this, IEC 60601-1 sets out specific requirements for the PESS.
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