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Implementering och riskhantering vid införande av IEC 62353 för testning av medicinteknisk utrustning
KTH, School of Engineering Sciences in Chemistry, Biotechnology and Health (CBH), Biomedical Engineering and Health Systems.
KTH, School of Engineering Sciences in Chemistry, Biotechnology and Health (CBH), Biomedical Engineering and Health Systems.
2022 (Swedish)Independent thesis Basic level (university diploma), 10 credits / 15 HE creditsStudent thesisAlternative title
Implementation and Risk Management upon Introduction of IEC 62353for Testing Medical Equipment (English)
Abstract [sv]

IEC 60601 elsäkerhetstest används fortfarande på många medicintekniskaavdelningar på sjukhus för testning av utrustning i samband med ankomstkontrolloch reparation. Denna rapport utreder möjligheten att ta fram ett underlag för attbörja implementera IEC 62353 som elsäkerhetsteststandard istället för IEC 60601.Studien fokuserar på huruvida Karolinska Universitetssjukhuset bör tillämpa IEC62353 som sin elsäkerhetsteststandard. Vidare diskuteras även skillnaderna mellande två ovanstående standarderna. Detta görs genom att ta reda på hur KarolinskaUniversitetssjukhuset ställer sig i frågan och informationsinsamling, samt hur IEC62353 standarden tillämpas i industrin.Den information som framställs i resultatet efter kontakt med flera sjukhus visar tvåolika aspekter. Den ena är självständig tillämpning av IEC 62353 som enelsäkerhetsteststandard, den andra är att följa tillverkarens instruktioner. Framtidastudier som kan ge tydligare vägledning ur tillverkarens synvinkel föreslås. 

Abstract [en]

IEC 60601 electrical safety tests are still used in many medical engineeringdepartments in hospitals for testing equipment in connection with arrival controland repair. This report investigates the possibility of producing a basis for starting toimplement IEC 62353 as an electrical safety test standard instead of IEC 60601.The study focuses on whether Karolinska University Hospital should apply IEC62353 as its electrical safety test standard. Furthermore, the differences between thetwo above standards are discussed. This is done by finding out how the KarolinskaUniversity Hospital responds to the question and the collection of information, aswell as how the IEC 62353 standard is applied in industry.The information presented in the results after contact with several hospitals showstwo different aspects. One is an independent application of IEC 62353 as an electricalsafety test standard, the other is to follow the manufacturer's instructions. Futurestudies that can provide clearer guidance from the manufacturer's point of view arerecommended. 

Place, publisher, year, edition, pages
2022. , p. 36
Series
TRITA-CBH-GRU ; 2022:080
Keywords [en]
Safety protocol, medical technology, IEC 62353, IEC 60601, electrical safety test
Keywords [sv]
Säkerhetsprotokoll, medicinteknik, IEC 62353, IEC 60601, elsäkerhetstest
National Category
Other Medical Engineering
Identifiers
URN: urn:nbn:se:kth:diva-315797OAI: oai:DiVA.org:kth-315797DiVA, id: diva2:1684046
Subject / course
Medical Engineering
Educational program
Bachelor of Science in Engineering - Medical Technology
Supervisors
Examiners
Available from: 2022-07-28 Created: 2022-07-20 Last updated: 2022-07-28Bibliographically approved

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Implementering av IEC 62353(655 kB)309 downloads
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