Zagotavljanje skladnosti medicinske programske opreme na primeru simulatorja robotskega manipulatorja

NAGLIČ, ŽIGA (author), Mihelj, Matjaž (mentor)

Programska oprema medicinskih pripomočkov, kot je tudi nadzorni sistem naprave za protonsko terapijo, mora biti izdelana v skladu z ustreznimi standardi, da lahko z gotovostjo trdimo, da je dovolj varna in učinkovita za uporabo v stiku s pacientom. Cilj pričujočega magistrskega dela je na praktičnem primeru razvoja simulatorja sistema za pozicioniranje pacienta pri napravi za protonsko terapijo opisati in prikazati vse s strani standardov predpisane postopke razvoja medicinske programske opreme. V uvodnem delu bralca seznanimo s tehnologijo obsevanja s protonskimi žarki in sestavnimi deli naprave za protonsko terapijo. Nakažemo tudi motivacijo za razvoj programske opreme po ustreznih medicinskih standardih. Sledi predstavitev področja standardizacije medicinskih pripomočkov in standarda za razvoj in vzdrževanje medicinske programske opreme IEC 62304. V sklopu postopkov iz življenjskega cikla medicinske programske opreme se dotaknemo tudi sistemov vodenja kakovosti in uporabe obvladovanja tveganja. V nadaljevanju, za namen razvoja simulatorja sistema za pozicioniranje pacienta, povzamemo še standard IEC 61217, ki ureja področje koordinatnih sistemov in zapisa pozicij v radioterapiji. Predstavimo tudi zahteve glede natančnosti pozicioniranja in podamo kratek pregled najbolj pogosto uporabljenih tehnologij. Vse skupaj zakroži praktični prikaz aplikacije predstavljenih standardov na konkretnem razvoju simulatorja sistema za pozicioniranje pacienta, ki je namenjen testiranju in validaciji medicinske programske opreme, natančneje nadzornega sistema naprave za protonsko terapijo. S pomočjo postopkov definiranih v standardih smo uspešno izdelali programsko kodo in vso pripadajočo dokumentacijo, s katero dokazujemo, da simulator ustrezno opravlja svojo funkcijo in ga lahko uporabljamo za predvideni namen.

• Language: Slovenian
• Keywords: protonska terapija, medicinska programska oprema, IEC 62304, IEC 61217, pozicioniranje pacienta, simulator, robotski manipulator
• Work type: Master's thesis/paper
• Organization: FE - Faculty of Electrical Engineering
• Year: 2018
• PID: 20.500.12556/RUL-103746
• Publication date in RUL: 24.09.2018

Secondary language

• Language: English
• Title: Ensuring medical device software compliance using the example of a robot manipulator simulator

Abstract

Medical device software such as a proton therapy machine control system must be manufactured according to the relevant standards so we can prove that it is safe and effective enough to be used in contact with the patient. The main aim of this master's thesis is to present a practical development example of a patient positioning system simulator with all required life cycle processes. First we inform the reader about the field of proton therapy and describe the subsystems of a proton therapy machine. We also present the motivation to develop the software control system according to the medical device standards. This is followed by a presentation of medical device standardization and medical device software life cycle processes standard IEC 62304. We also briefly present the quality management systems and application of risk management processes. In relation to the patient positioning system simulator development we sum up the radiotherapy standard IEC 61217 which defines the coordinates, movements and scales. Next is an overview of positioning accuracy requirements and most frequently used patient positioning technologies. Everything is brought together by a practical application of presented standards. We show a development example of a patient positioning system simulator which is to be used for testing and validation of medical software, namely the proton therapy machine control system. With the help of processes defined by the standards we successfully implemented the simulator software and prepared all required documentation. The documentation is used to prove that the simulator behaves correctly and can be used for its intended purpose.

• Keywords: proton therapy, medical software, IEC 62304, IEC 61217, patient positioning, simulator, robot manipulator