Berater für EMV und elektr. Sicherheit
The European legislation defines systems and procedure packs and distinguishes between different configurations. The regulatory requirements placed on the manufacturer are heavily dependent on these configurations. This article will explain to you what legislators understand by systems and procedure packs, what the most important legal requirements are for manufacturers, and what common mistakes you should avoid. 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). The IEC 61010 family Scope of application IEC 61010 is a series of standards that formulates safety requirements for electrical equipment for measurement,…
DetailsIEC 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.…
DetailsThe system architecture describes how a (medical) device is composed of components and how the components are related to each other via interfaces. In standalone software system architecture and software architecture fall together. Documentation of the system architecture The documentation should reveal the individual components and their interaction. We recommend that you use standard notations…
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