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Electromagnetic Compatibility Requirements for Medical Device Certification
University of Borås, Faculty of Textiles, Engineering and Business.
University of Borås, Faculty of Textiles, Engineering and Business.
2017 (English)Independent thesis Basic level (university diploma), 10 credits / 15 HE creditsStudent thesisAlternative title
Elektromagnetisk Kompatibilitet Krav för Medicinsk Utrustning Certifiering (Swedish)
Abstract [en]

Until approximately 50 years ago, wireless electronics was confined to military purposes. With the advancement of technology, consumer electronics found widespread applications in almost every aspect of our lives and numerous devices were developed using electromagnetic waves to transfer different types of data. In light of such advancements, the electromagnetic compatibility (EMC) evolved from a military concept to regulate the radio frequency requirements of the battlefield equipment to a mature and essential part in manufacturing and employing electronic devices. Medical devices were no exception and largely benefited from the ease of connectivity and mobility provided by usage of wireless electronics. Due to the sensitive nature of medical devices and extreme consequences of their malfunction, EMC grew to a centric issue in design and production of such devices. This work examines the electromagnetic compatibility of a wearable biomedical measurement system used for the assessment of mental stress of combatants in real time. This system was developed as a part of the ARTEC project and supported by the Spanish Ministry of Defense through the Future Combatant program [1]. We focus on the EMC of the electrocardiogram of the system and aim to identify its EMC requirements of this system while assessing it against various standards and protocols. Throughout this study, we elucidate the fundamentals of electromagnetic compatibility with specific attention to medical devices. Furthermore, we present our results after conducting several EMC tests to measure the compatibility of the electrocardiogram device using the Intertek guidelines. The emission test was performed while essential counter measures such as appropriate shielding and anti-interference filters had been applied.

Place, publisher, year, edition, pages
2017.
Keywords [en]
CE, ECG, EMC, EMI, Emission, ESD, Healthcare, Medical Device, Military Standards, RFI
National Category
Engineering and Technology
Identifiers
URN: urn:nbn:se:hb:diva-13705OAI: oai:DiVA.org:hb-13705DiVA, id: diva2:1184413
Subject / course
Mechanical engineering
Available from: 2018-03-13 Created: 2018-02-21 Last updated: 2018-03-13Bibliographically approved

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CiteExportLink to record
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Citation style
  • apa
  • harvard1
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf