Evaluation of the destructive test in medical devices manufacturing

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62156489%3A43110%2F16%3A43909499" target="_blank" >RIV/62156489:43110/16:43909499 - isvavai.cz</a>

Výsledek na webu

<a href="http://mme2016.tul.cz/conferenceproceedings/mme2016_conference_proceedings.pdf" target="_blank" >http://mme2016.tul.cz/conferenceproceedings/mme2016_conference_proceedings.pdf</a>

DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Evaluation of the destructive test in medical devices manufacturing

Popis výsledku v původním jazyce

Testing the quality of produced medical devices is undoubtedly a crucial issue. If a product of compromised quality is sold, it would first of all have an impact on the health of patients and, consequently, on the economic performance of the manufacturer. Destructive testing of medical devices is expensive and there are attempts to replace it by non-destructive tests. During the substitution of destructive tests with non-destructive ones, the strength of the test should be rationalized at the stage of process control planning. To do so, logit or probit models are the first choice. This article deals with an evaluation of typical destructive test results from both product and process verification and validation of medical devices. The differences between the estimated logit and probit models are discussed and arguments when to prefer which one are collected. Finally, replacement of destructive testing by non-destructive testing is evaluated numerically.

Název v anglickém jazyce

Evaluation of the destructive test in medical devices manufacturing

Popis výsledku anglicky

Testing the quality of produced medical devices is undoubtedly a crucial issue. If a product of compromised quality is sold, it would first of all have an impact on the health of patients and, consequently, on the economic performance of the manufacturer. Destructive testing of medical devices is expensive and there are attempts to replace it by non-destructive tests. During the substitution of destructive tests with non-destructive ones, the strength of the test should be rationalized at the stage of process control planning. To do so, logit or probit models are the first choice. This article deals with an evaluation of typical destructive test results from both product and process verification and validation of medical devices. The differences between the estimated logit and probit models are discussed and arguments when to prefer which one are collected. Finally, replacement of destructive testing by non-destructive testing is evaluated numerically.

Druh

D - Stať ve sborníku

CEP obor

BB - Aplikovaná statistika, operační výzkum

OECD FORD obor

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Projekt

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Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2016

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název statě ve sborníku

Mathematical Methods in Economics 2016: Conference Proceedings

ISBN

978-80-7494-296-9

ISSN

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e-ISSN

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Počet stran výsledku

6

Strana od-do

37-42

Název nakladatele

Technická univerzita v Liberci

Místo vydání

Liberec

Místo konání akce

Liberec

Datum konání akce

6. 9. 2016

Typ akce podle státní příslušnosti

WRD - Celosvětová akce

Kód UT WoS článku

000385239500007