All4tec (France)

The increasing complexity of the medical regulatory environment and the inherent complexity of medical devices, especially due to the increased use of connected devices and embedded control software, impose adoption of new methods and tools for the system design, safety and security analyses. In this paper, we propose a method and an associated toolchain to couple model-based system engineering and safety/security analyses at the design phase of medical devices. The method is compliant with ANSI/AAMI/ISO TIR57 safety and security guidance, and compatible with INCOSE Biomedical-Healthcare Model-Based Systems Engineering works. The toolchain is based on a system architecture modelling tool and supports medical device domain specific reference architecture, as well as tools for safety and security risk analyses. The proposed method and toolchain are illustrated by considering a RGB’s TOF-CUFF monitor device analyzed in the scope of the AQUAS project as a medical device use case.

La Compagnie nationale du Rhône (CNR) a été confrontée dans le cadre des nombreuses opérations de restauration des milieux aquatiques qu'elle mène, au manque de filières de traitement pour les plantes exotiques envahissantes et en particulier concernant les terres colonisées par des rhizomes de renouées du Japon sur des gros volumes. Depuis 2011, la CNR a donc décidé de développer en interne diverses méthodes de traitement ayant pour objectif la dévitalisation immédiate des rhizomes de la plante dans les déblais de terrassement. Après deux ans de tests, et trois ans d'application en interne des méthodes expérimentées, les résultats sont très satisfaisants et une technique particulièrement efficace a pu être proposée et déployée sur des opérations de restauration de grande échelle suivies par la CNR. La méthode en question est constituée de deux étapes clefs : une première de criblage pour séparer les éléments fins des éléments grossiers présents dans les matériaux alluviaux, la seconde pour dévitaliser les rhizomes présents dans la fraction grossière par concassage fin. Les matériaux traités peuvent ainsi être remis au cours d'eau, valorisés comme substrat de plantation ou évacués dans une installation de stockage de déchets inertes (ex « décharge de classe 3 »).

Software product lines (SPLs) are families of software systems sharing common assets and exhibiting variabilities specific to each product member of the family. Commonalities and variabilities are often represented as features organized in a feature model. Due to combinatorial explosion of the number of products induced by possible features combinations, exhaustive testing of SPLs is intractable. Therefore, sampling and prioritization techniques have been proposed to generate sorted lists of products based on coverage criteria or weights assigned to features. Solely based on the feature model, these techniques do not take into account behavioural usage of such products as a source of prioritization. In this paper, we assess the feasibility of integrating usage models into the testing process to derive statistical testing approaches for SPLs. Usage models are given as Markov chains, enabling prioritization of probable/rare behaviours. We used featured transition systems, compactly modelling variability and behaviour for SPLs, to determine which products are realizing prioritized behaviours. Statistical prioritization can achieve a significant reduction in the state space, and modelling efforts can be rewarded by better automation. In particular, we used MaTeLo, a statistical test cases generation suite developed at ALL4TEC. We assess feasibility criteria on two systems: Claroline, a configurable course management system, and Sferion™, an embedded system providing helicopter landing assistance.

This paper aims at describing the contribution of the technological brick Safety Architect to the CRYSTAL project. The goal of the CRYSTAL project is to provide a platform of interoperability between tools supporting all the steps constituting the lifecycle of a product.