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Title:
Primerjalna analiza standardov kakovosti za medicinske pripomočke in dentalne zlitine
Authors:
ID
Manojlović Antić, Jelena
(Author)
ID
Maletič, Matjaž
(Mentor)
More about this mentor...
Files:
MAG_Manojlovic_Antic_Jelena_2023.pdf
(1,39 MB)
MD5: 9A89EE47FB345430057E70A9A2734178
Language:
Slovenian
Work type:
Master's thesis/paper
Typology:
2.09 - Master's Thesis
Organization:
FOV - Faculty of Organizational Sciences in Kranj
Abstract:
Ključno vlogo pri zagotavljanju varnosti in kakovosti medicinskih pripomočkov, med katere spadajo tudi dentalne zlitine, igrajo zakoni in regulative. Pri tem pa imajo pomembno vlogo tudi standardi, ki služijo kot smernice in spodbujajo kakovost, strokovnost, izboljšujejo procese, povečujejo varnost pacientov in spodbujajo zaupanje v zobozdravstveno dejavnost. Namen zaključnega dela je bil, da skozi analizo standardov SIST EN ISO 13485 in SIST EN ISO 22674 prikažemo pomembnost le-teh in na kakšen način vplivajo na kakovost dentalnih zlitin ter posledično na varnost in zadovoljstvo pacientov. Preučili smo strokovno in znanstveno literaturo s področja obravnavane tematike in v teoretičnem delu uporabljali metodo analize in kompilacije, ki temelji na literaturi, izpiskih, citatih in navedbah drugih avtorjev, ter deskriptivno metodo, s katero opisujemo in interpretiramo najpomembnejše pojme s preučevanega področja. V empiričnem delu smo kot najbolj ustrezen raziskovalni pristop izbrali primerjalno analizo. Oba standarda smo podrobneje opisali in analizirali, nato pa zaradi lažje in preglednejše obdelave podatkov izvedli še tabelarično primerjavo. Ugotovili smo, da slovenska zakonodaja uspešno regulira področje medicinskih pripomočkov. Prav tako smo ugotovili, da vsi, ki so vključeni v izdelavo zobno protetičnih izdelkov, sledijo smernicam primerjanih standardov ISO. Z upoštevanjem teh standardov se doseže visoka raven kakovosti, zanesljivosti in varnosti medicinskih pripomočkov ter s tem prispeva k izboljšanju zdravja in dobremu počutju pacientov.
Keywords:
standardi kakovosti
,
medicinski pripomočki
,
varnost medicinskih pripomočkov
,
dentalne zlitine
Place of publishing:
Maribor
Year of publishing:
2023
PID:
20.500.12556/DKUM-85831
COBISS.SI-ID:
171695875
Publication date in DKUM:
10.11.2023
Views:
410
Downloads:
40
Metadata:
Categories:
FOV
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:
MANOJLOVIĆ ANTIĆ, Jelena, 2023,
Primerjalna analiza standardov kakovosti za medicinske pripomočke in dentalne zlitine
[online]. Master’s thesis. Maribor. [Accessed 21 April 2025]. Retrieved from: https://dk.um.si/IzpisGradiva.php?lang=eng&id=85831
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Licences
License:
CC BY-NC-ND 4.0, Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
Link:
http://creativecommons.org/licenses/by-nc-nd/4.0/
Description:
The most restrictive Creative Commons license. This only allows people to download and share the work for no commercial gain and for no other purposes.
Licensing start date:
13.09.2023
Secondary language
Language:
English
Title:
A comparative analysis of quality standards for medical devices and dental alloys
Abstract:
The laws and regulations play a crucial role in ensuring the safety and quality of medical devices, including dental alloys. Standards also play a significant role in serving as guidelines and promoting quality, expertise, process improvement, enhancing patient safety, and fostering trust in dental healthcare. The purpose of this thesis was to demonstrate the importance of these standards and how they influence the quality of dental alloys, and consequently, patient safety and satisfaction, through the analysis of SIST EN ISO 13485 and SIST EN ISO 22674 standards. We examined professional and scientific literature related to the topic and used an analytical and compilation method based on literature, excerpts, quotes, and citations from other authors in the theoretical part. We also used a descriptive method to describe and interpret the most important concepts in the field under investigation. In the empirical part, we chose a comparative analysis as the most suitable research approach. We provided detailed descriptions and analyses of both standards and conducted a tabular comparison for easier and more transparent data processing. We found that Slovenian legislation effectively regulates the field of medical devices. Furthermore, we observed that all those involved in the production of dental prosthetic products adhere to the guidelines of the compared ISO standards. By following these standards, a high level of quality, reliability, and safety of medical devices is achieved, contributing to the improvement of patient health and well-being.
Keywords:
quality satandards
,
medical devices
,
safety of medical devices
,
dental alloys
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