2017
Autores
Harrison, MD; Masci, P; Campos, JC; Curzon, P;
Publicação
SOFTWARE ENGINEERING IN HEALTH CARE, SEHC 2014
Abstract
One way of contributing to a demonstration that a medical device is acceptably safe is to show that the device satisfies a set of requirements known to mitigate hazards. This paper describes experience using formal techniques to model an IV infusion device and to prove that the modelled device captures a set of requirements. The requirements chosen for the study are based on a draft proposal developed by the US Food and Drug Administration (FDA). A major contributor to device related errors are (user) interaction errors. For this reason the chosen models and requirements focus on user interface related issues.
2017
Autores
Calvary, G; Nichols, J; Campos, JC; Nunes, NJ; Campos, PF;
Publicação
Proc. ACM Hum. Comput. Interact.
Abstract
2017
Autores
Harrison, MD; Masci, P; Campos, JC; Curzon, P;
Publicação
IEEE TRANSACTIONS ON HUMAN-MACHINE SYSTEMS
Abstract
One part of demonstrating that a device is acceptably safe, often required by regulatory standards, is to show that it satisfies a set of requirements known to mitigate hazards. This paper is concerned with how to demonstrate that a user interface software design is compliant with use-related safety requirements. A methodology is presented based on the use of formal methods technologies to provide guidance to developers about addressing three key verification challenges: 1) how to validate a model, and show that it is a faithful representation of the device; 2) how to formalize requirements given in natural language, and demonstrate the benefits of the formalization process; and 3) how to prove requirements of a model using readily available formal verification tools. A model of a commercial device is used throughout the paper to demonstrate the methodology. A representative set of requirements are considered. They are based on US Food and Drug Administration (FDA) draft documentation for programmable medical devices, and on best practice in user interface design illustrated in relevant international standards. The methodology aims to demonstrate how to achieve the FDA's agenda of using formal methods to support the approval process for medical devices.
2017
Autores
Harrison, MD; Masci, PM; Campos, JC; Curzon, P;
Publicação
Handbook of Formal Methods in Human-Computer Interaction
Abstract
This chapter explores a layered approach to the analysis of the Nuclear Power Plant Control System described in Chap. 4. A model is specified to allow the analysis of use-centred properties based on generic templates. User interface properties include the visibility of state attributes, the clarity of the mode structure and the ease with which an action can be recovered from. Property templates are used as heuristics to ease the construction of requirements for the control system interface. © Springer International Publishing AG 2017.
2017
Autores
Harrison, MD; Drinnan, M; Campos, JC; Masci, P; Freitas, L; di Maria, C; Whitaker, M;
Publicação
FORMAL ASPECTS OF COMPONENT SOFTWARE (FACS 2017)
Abstract
The paper describes the practical use of a model checking technique to contribute to the risk analysis of a new paediatric dialysis machine. The formal analysis focuses on one component of the system, namely the table-driven software controller which drives the dialysis cycle and deals with error management. The analysis provided evidence of the verification of risk control measures relating to the software component. The paper describes the productive dialogue between the developers of the device, who had no experience or knowledge of formal methods, and an analyst who had experience of using the formal analysis tools. There were two aspects to this dialogue. The first concerned the translation of safety requirements so that they preserved the meaning of the requirement. The second involved understanding the relationship between the software component under analysis and the broader concern of the system as a whole. The paper focuses on the process, highlighting how the team recognised the advantages over a more traditional testing approach.
2017
Autores
Pinto, M; Gonçalves, M; Masci, P; Campos, JC;
Publicação
FORMAL ASPECTS OF COMPONENT SOFTWARE (FACS 2017)
Abstract
Applying model-based testing to interactive systems enables the systematic testing of the system by automatically simulating user actions on the user interface. It reduces the cost of (expensive) user testing by identifying implementations errors without the involvement of human users, but raises a number of specific challenges, such as how to achieve good coverage of the actual use of the system during the testing process. This paper describes TOM, a model-based testing framework that uses a combination of tools and mutation testing techniques to maximize testing of user interface behaviors.
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