Concept for the testing of automated functions in therapeutic medical devices-Reference-Cited by-同舟云学术

Concept for the testing of automated functions in therapeutic medical devices

Published:2022-11-01 Issue:11 Volume:70 Page:946-956
ISSN:0178-2312
Container-title:at - Automatisierungstechnik
language:en
Short-container-title:

Author:

Henn Sandra¹,Kabuth Bastian¹,Schollemann Franziska¹,Hennigs Carlotta¹,Männel Georg²,Angern Michael²,Rostalski Philipp¹²

Affiliation:

1. Institute for Electrical Engineering in Medicine, Universität zu Lübeck , Lübeck , Germany

2. Fraunhofer IMTE , Lübeck , Germany

Abstract

Abstract In this paper, a testing for highly automated function (HAF) is adapted from the automotive industry to therapeutic medical devices. It contains different steps to achieve a safety argumentation: First, scenarios of interest (SoI) based on a systematic generalization of failure mode and effect analysis (FMEA) are identified, then the concrete scenarios are generated using design of experiment (DoE). These scenarios are simulated virtually and physically and are then evaluated. The procedure is explained with the use of examples.

Publisher

Walter de Gruyter GmbH

Subject

Electrical and Electronic Engineering,Computer Science Applications,Control and Systems Engineering

Link

https://www.degruyter.com/document/doi/10.1515/auto-2022-0010/pdf

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