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Optimizacija in medicinska validacija procesa avtomatskega spajkanja : magistrsko delo magistrskega študijskega programa II. stopnje Strojništvo
Zupan, Matic, 1999-, inženir strojništva
V magistrskem delu je opisan proces avtomatskega spajkanja, ki predstavlja del montažno izdelovalnega procesa, kjer se sestavlja medicinski pripomoček, ki mora sovpadati z zahtevami standarda za ...medicinske pripomočke ISO 13485. Ena od zahtev standarda proizvajalcu medicinskih pripomočkov naroča podrobno vodenje medicinske validacije in zapisa le te. Zaradi spremembe procesa avtomatskega procesa je bilo potrebno opraviti ponovno validacijo procesa. V ta namen smo z metodo načrtovanja eksperimentov DOE določili optimalne vrednosti parametrov vplivnih faktorjev temperature, časa predgretja, časa in hitrosti podajanja žice ter časa taljenja žice. S predlaganimi optimalnimi parametri smo opravili 10 potrditvenih testov in določili interval zaupanja. Zatem je sledila še analiza prečnih presekov in validacija po medicinskem standardu s 300 ponovitvami.
Type of material - master's thesis
; adult, serious
Publication and manufacture - Ljubljana : [M. Zupan], 2025
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