Concept for the testing of automated functions in therapeutic medical devices Konzept für die Prüfung von autonomen Funktionen von therapeutischen Medizingeräten

Sandra Henn; Bastian Kabuth; Franziska Schollemann; Carlotta Hennigs; Georg Männel; Michael Angern; Philipp Rostalski

doi:10.1515/auto-2022-0010

Concept for the testing of automated functions in therapeutic medical devices Konzept für die Prüfung von autonomen Funktionen von therapeutischen Medizingeräten

Sandra Henn^*, Bastian Kabuth, Franziska Schollemann, Carlotta Hennigs, Georg Männel, Michael Angern, Philipp Rostalski

^*Corresponding author for this work

Institute of Electrical Engineering in Medicine

1 Citation (Scopus)

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.

Original language	English
Journal	At-Automatisierungstechnik
Volume	70
Issue number	11
Pages (from-to)	946-956
Number of pages	11
ISSN	0178-2312
DOIs	https://doi.org/10.1515/auto-2022-0010
Publication status	Published - 01.11.2022

Funding

Research funding: S. Henn and F. Schollemann were supported by the “Cross-Innovation-Center–TANDEM Phase III (TANDEM III-CIC)” LPW-E/1.1.1/1521. G. Männel and M. Angern were supported by the European Union–European Regional Development Fund (ERDF), the Federal Government and Land Schleswig Holstein, Project No. 12420002. B. Kabuth was supported by “Medical Cause and Effects Analysis” within the AI funding policy of Schleswig Holstein (“KI-Förderrichtlinie”, Project No. 220 21 011). We thank Charlott Danielson (Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering) for her critical review of regarding regulatory aspects of this project.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being
SDG 9 Industry, Innovation, and Infrastructure

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Cite this

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title = "Concept for the testing of automated functions in therapeutic medical devices Konzept f{\"u}r die Pr{\"u}fung von autonomen Funktionen von therapeutischen Medizinger{\"a}ten",

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.",

author = "Sandra Henn and Bastian Kabuth and Franziska Schollemann and Carlotta Hennigs and Georg M{\"a}nnel and Michael Angern and Philipp Rostalski",

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Concept for the testing of automated functions in therapeutic medical devices Konzept für die Prüfung von autonomen Funktionen von therapeutischen Medizingeräten. / Henn, Sandra ; Kabuth, Bastian ; Schollemann, Franziska et al.
In: At-Automatisierungstechnik, Vol. 70, No. 11, 01.11.2022, p. 946-956.

Research output: Journal Articles › Journal articles › Research › peer-review

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T1 - Concept for the testing of automated functions in therapeutic medical devices Konzept für die Prüfung von autonomen Funktionen von therapeutischen Medizingeräten

AU - Henn, Sandra

AU - Kabuth, Bastian

AU - Schollemann, Franziska

AU - Hennigs, Carlotta

AU - Männel, Georg

AU - Angern, Michael

AU - Rostalski, Philipp

PY - 2022/11/1

Y1 - 2022/11/1

N2 - 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.

AB - 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.

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DO - 10.1515/auto-2022-0010

M3 - Journal articles

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ER -

Concept for the testing of automated functions in therapeutic medical devices Konzept für die Prüfung von autonomen Funktionen von therapeutischen Medizingeräten

Abstract

Funding

UN SDGs

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