20.500.12556/RUL-167542 Sočasni razvoj medicinskega sterilizatorja z njegovo IEC 61010 verifikacijo Concurrent development of medical sterilizer and its IEC 61010 compliance Diplomska naloga obravnava sočasen razvoj medicinskega sterilizatorja za endoskope in doseganje skladnosti s standardom IEC 61010. Namesto tradicionalnega sekvenčnega razvoja smo uporabili sočasni pristop za optimizacijo regulacije temperature. Razvili smo regulator, programsko kodo, električno shemo in vezje za natančno upravljanje temperature komore. Testiranje je potrdilo skladnost sterilizatorja s standardom ISO 15883. Opravili smo varnostne preizkuse po standardu IEC 61010. Z zgodnjo vključitvijo verifikacije smo skrajšali razvojni čas in optimirali stroške izdelave sterilizatorja. Sočasen razvoj je omogočil hkratno validacijo programske in strojne opreme, kar rezultira tudi v zanesljivosti delovanja in holistični skladnosti naprave. Rezultati potrjujejo, da sočasno preverjanje skladnosti med razvojem bistveno pospeši certificiranje, hkrati pa zagotavlja visok nivo varnosti in zanesljivosti naprave. The thesis explores the concurrent development of a medical endoscope sterilizer and its compliance with IEC 61010. Unlike the traditional sequential approach, we applied concurrent engineering to optimize temperature regulation. A temperature controller was developed alongside software code, an electrical schematic, and a circuit for precise chamber temperature control. Testing confirmed compliance with ISO 15883 and successful completion of all IEC 61010 safety evaluations. By integrating verification early in the process, we reduced development time and minimized potential redesigns, fixes and/or adjustments. The use of concurrent engineering allowed simultaneous hardware and software validation, ensuring functional reliability and regulatory conformity. The findings demonstrate that real-time compliance assessment during development significantly accelerates certification while maintaining high apparatus safety and performance standards. This approach proves effective for optimizing complex medical apparatusses with precise controls and stringent regulatory compliance. skladnost naprav IEC 61010 meritve sočasni razvoj sterilizatorji device compliance IEC 61010 measurements concurrent development sterilizers true false false Slovenski jezik Angleški jezik Diplomsko delo/naloga 2025-02-27 08:30:34 2025-02-27 08:30:38 2025-03-11 11:11:52 0000-00-00 00:00:00 2025 0 0 XXII, 78 str. 2025 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 615.478.73:616-072.1-71:004.057.2(043.2) 270487 22855757 38655.pdf 38655.pdf 1 A0D05A1DC362EEA7407BB4DD4AFD624F 8866a6d46252a924ea472dc267b49ce356b366d9eb73c71f532d56d04e622cbd d27988a9-f4db-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=200165 Fakulteta za strojništvo 0 0 0