Blog: Medical Electrical Systems
by Dipl Ing Armin Gärtner and Andreas Baaske
Medical electrical systems are defined in chapter 16 of IEC 60601-1 3rd Edition. The former collateral standard EN 60601-1-1 (system standard) has been integrated into IEC 60601 with the third edition. This third edition of the medical electrical safety standard does not consider seperated, single devices anymore, i considers medical electrical devices AND (interconnected) systems instead. Chapter 14 of IEC 60601-1 is dedicated to medical electrical equipment and systems connected to a network.
This blog describes the "system" definition regarding the regulatory affairs and the requirements of IEC 60601-1 3rd ed. It also outlines the requirements of different standards regarding the installation and usage of medical electrical systems using an example of configuring a mobile cart for medical use. Furthermore medical electrical systems (MES) in practice will be discussed as well as functional combinations of medical and non- medical electrical devices using different signal types like DVI, SDI, VIDEO and power isolation.
Medical Electrical Systems (MES)
Many different electrical systems as combinations of medical and non medical devices are being installed in healthcare day by day. These systems can be devided into two groups:
- Formal group according to medical directives and laws (Europe: MDD Medical device directive)
- Normative group according to medical standards and norms like IEC 60601-1 and IEC 60601-1-2
This Blog focusses the normative group and the requirements for medical electrical systems according to IEC 60601-1 third edition.
... to be continued