In:
at - Automatisierungstechnik, Walter de Gruyter GmbH, Vol. 70, No. 11 ( 2022-11-25), p. 946-956
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.
Type of Medium:
Online Resource
ISSN:
0178-2312
,
2196-677X
DOI:
10.1515/auto-2022-0010
Language:
English
Publisher:
Walter de Gruyter GmbH
Publication Date:
2022
detail.hit.zdb_id:
629186-7
detail.hit.zdb_id:
2027287-X
SSG:
15,3
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