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Zuverlässigkeits-technik in biomedizinischen Systemen by Jeferson Dias, Jonatas Dias, Millena Souza

Zuverlässigkeits-technik in biomedizinischen Systemen

by Jeferson Dias , Jonatas Dias , Millena Souza
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Book cover type: Paperback
  • ISBN13: 9786209541889
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Verlag Unser Wissen
  • Publisher Imprint: Verlag Unser Wissen
  • Publication Date:
  • Pages: 160
  • Original Price: GBP 69.51
  • Language: German
  • Edition: N/A
  • Item Weight: 223 grams
  • BISAC Subject(s): Engineering (General)

Die Zuverl�ssigkeitstechnik f�r Medizinprodukte spielt eine wichtige Rolle, wenn es darum geht, sicherzustellen, dass die in der Diagnostik, Therapie und �berwachung eingesetzten Ger�te w�hrend ihres gesamten Lebenszyklus sicher und mit konstanter Leistung funktionieren. Der Schwerpunkt liegt auf der Erkennung, Vermeidung und Begrenzung von Fehlern, die die klinische Wirksamkeit oder die Patientensicherheit beeintr�chtigen k�nnten.Der Prozess reicht von der Konstruktion - mit Fehlerbaumanalysen (FTA) und beschleunigten Tests - bis zur Produktion, Wartung und �berwachung im Feld. Statistische Methoden und Vorhersageinstrumente erm�glichen es, Ausfallwahrscheinlichkeiten abzusch�tzen, das Design zu optimieren und Betriebsrisiken und -kosten zu reduzieren.Neben der technischen Dimension erf�llt die Zuverl�ssigkeit auch die Anforderungen von Aufsichtsbeh�rden wie ANVISA, FDA und EMA, die den Nachweis einer sicheren, wirksamen und konsistenten Leistung bei bestimmungsgem� er Verwendung verlangen. Mehr als eine Qualit�tsanforderung stellt die Zuverl�ssigkeitstechnik also eine ethische Verpflichtung gegen�ber dem menschlichen Leben und der Nachhaltigkeit des Gesundheitssystems dar.

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