scholarly journals A Hazard Analysis Method for Systematic Identification of Safety Requirements for User Interface Software in Medical Devices

2017 ◽  
pp. 284-299 ◽  
Author(s):  
Paolo Masci ◽  
Yi Zhang ◽  
Paul Jones ◽  
José C. Campos
Keyword(s):  
User Interface ◽  
Medical Devices ◽  
Hazard Analysis ◽  
Analysis Method ◽  
Safety Requirements ◽  
Systematic Identification

Usability Engineering Recommendations for Next-Gen Integrated Interoperable Medical Devices

2021 ◽  
Vol 55 (4) ◽  
pp. 132-142
Author(s):  
Paolo Masci ◽  
Sandy Weininger
Keyword(s):  
Medical Devices ◽  
Hazard Analysis ◽  
Technical Committee ◽  
Medical System ◽  
Analysis Method ◽  
Usability Engineering ◽  
Design Problems ◽  
Model Based ◽  
Key Aspects ◽  
System Prototype

Abstract This article reports on the development of usability engineering recommendations for next-generation integrated interoperable medical devices. A model-based hazard analysis method is used to reason about possible design anomalies in interoperability functions that could lead to use errors. Design recommendations are identified that can mitigate design problems. An example application of the method is presented based on an integrated medical system prototype for postoperative care. The AAMI/UL technical committee used the results of the described analysis to inform the creation of the Interoperability Usability Concepts, Annex J, which is included in the first edition of the new ANSI/AAMI/UL 2800-1:2019 standard on medical device interoperability. The presented work is valuable to experts developing future revisions of the interoperability standard, as it documents key aspects of the analysis method used to create part of the standard. The contribution is also valuable to manufacturers, as it demonstrates how to perform a model-based analysis of use-related aspects of a medical system at the early stages of development, when a concrete implementation of the system is not yet available.

scholarly journals SARSSi*: a Safety Requirements Specification Method based on STAMP/STPA and i* language

2019 ◽  
Author(s):  
Jéssyka Vilela ◽  
Carla Silva ◽  
Jaelson Castro ◽  
Luiz Eduardo G. Martins ◽  
Tony Gorschek
Keyword(s):  
Hazard Analysis ◽  
Requirements Specification ◽  
Critical Systems ◽  
Safety Requirements ◽  
Safety Critical ◽  
Analysis Techniques ◽  
Specification Method ◽  
Systematic Identification ◽  
Initial Results

Context: traditional hazard analysis techniques were not proposed to be used in the Requirements Engineering (RE) process. Objective: The aim of this work is to present and discuss a new method for early safety requirements specification called SARSSi* to be used at the beginning of the development of safety-critical systems. Method: this goal is achieved through the combination of two techniques: (1) STAMP/STPA; and (2) i* language. Results: this paper attempts to bridge the gap between two parallel trends in systematic safety approaches – the combination of requirements and safety engineering techniques. Our method consists of six steps and guidelines to perform a preliminary hazard analysis and facilitate the systematic identification of safety-critical functions and components. Conclusions: We demonstrate the utility of our method by applying it in a real industry case study. The initial results show preliminary suitability of our method and its contribution to improving the visualization of the information generated in the hazard analysis such as the hazards, their causes, environmental conditions, and safety requirements.

scholarly journals Verification of User Interface Software: The Example of Use-Related Safety Requirements and Programmable Medical Devices

2017 ◽  
Vol 47 (6) ◽  
pp. 834-846 ◽  
Author(s):  
Michael D. Harrison ◽  
Paolo Masci ◽  
Jose Creissac Campos ◽  
Paul Curzon
Keyword(s):  
User Interface ◽  
Medical Devices ◽  
Safety Requirements

User Interface Requirements for Medical Devices

2021 ◽  
Author(s):  
Michael Wiklund ◽  
Erin Davis ◽  
Alexandria Trombley ◽  
Jacqueline Edwards
Keyword(s):  
User Interface ◽  
Medical Devices

scholarly journals Demonstrating that Medical Devices Satisfy User Related Safety Requirements

2017 ◽  
pp. 113-128 ◽  
Author(s):  
Michael D. Harrison ◽  
Paolo Masci ◽  
Jose Creissac Campos ◽  
Paul Curzon
Keyword(s):  
Medical Devices ◽  
Safety Requirements

Study on the Thermo-Hydrodynamic of a Dry Gas Seal in Helium Circulator for High Temperature Gas-Cooled Reactor

2011 ◽  
Author(s):  
Jianshu Lin ◽  
Hong Wang
Keyword(s):  
High Temperature ◽  
Film Flow ◽  
Three Dimensional ◽  
Maximum Temperature ◽  
Analysis Method ◽  
Dry Gas Seal ◽  
Safety Requirements ◽  
Simulation Results ◽  
Gas Seals ◽  
High Temperature Gas

A comprehensive analysis method is proposed to resolve the problem of simulating a complex thermo-flow with two kinds of distinct characteristic length in the dry gas seal, and a conjugated simulation of the complicated heat transfer and the gas film flow is carried out by using the commercial CFD software CFX. By using the proposed method, a three dimensional of velocity and pressure field in the gas film flow and the temperature distribution within the sealing rings are investigated for three kinds of film thickness, respectively. A comparison of thermo-hydrodynamics of the dry gas seals is conducted between the sealed gas of air and helium. The latter one is used in a helium circulator for High Temperature Gas-cooled Reactor (HTGR). From comparisons and discussions of a series of simulation results, it will be found that the comprehensive proposal is effective and simulation results are reasonable, and the maximum temperature rise in the dry gas seal is within the acceptable range of HTGR safety requirements.

scholarly journals Safety of Imported Machines - Selected Issues in the Context of Polish (UE) Regulation

2020 ◽  
Vol 2 (1) ◽  
pp. 174-182
Author(s):  
Agata Kielesińska
Keyword(s):  
Medical Devices ◽  
Safety Management ◽  
Quality Criteria ◽  
Safety Requirements ◽  
Specific Safety ◽  
A Priority ◽  
General Safety

AbstractThe purpose of the paper is to present the issues of ensuring the safety of machinery and equipment in accordance with the requirements of the Machinery Directive 2006/42/EC of May 17, 2006 on the essential requirements for machines, with regard to the sphere of their import and distribution. This issue is related to the dynamically developing trade in cheaper new machines, mainly from countries outside the EEA (including China) and is a priority for ensuring safety and protecting the health and life of users of this type of equipment in accordance with EU regulations. The use of a variety of machines in industry, in addition to general safety requirements, which may also include quality criteria, care for the environment and industry-specific safety management requirements (e.g. food, automotive, medical devices).

Deriving Safety-Related Scenarios to Support Architecture Evaluation

2011 ◽  
pp. 31-54 ◽  
Author(s):  
Dingding Lu ◽  
Robyn R. Lutz ◽  
Carl K. Chang
Keyword(s):  
System Development ◽  
Hazard Analysis ◽  
Unified Modeling Language ◽  
Use Cases ◽  
System Safety ◽  
System Decomposition ◽  
Unified Modeling ◽  
Safety Requirements ◽  
Analysis Process ◽  
Architectural Evaluation

This chapter introduces an analysis process that combines the different perspectives of system decomposition with hazard analysis methods to identify the safety-related use cases and scenarios. It argues that the derived safety-related use cases and scenarios, which are the detailed instantiations of system safety requirements, serve as input to future software architectural evaluation. Furthermore, by modeling the derived safety-related use cases and scenarios into UML (Unified Modeling Language) diagrams, the authors hope that visualization of system safety requirements will not only help to enrich the knowledge of system behaviors but also provide a reusable asset to support system development and evolution.

scholarly journals A Novel Hazard Analysis and Risk Assessment Approach for Road Vehicle Functional Safety through Integrating STPA with FMEA

2020 ◽  
Vol 10 (21) ◽  
pp. 7400
Author(s):  
Lei Chen ◽  
Jian Jiao ◽  
Tingdi Zhao
Keyword(s):  
Risk Assessment ◽  
Process Analysis ◽  
Hazard Analysis ◽  
International Standards ◽  
Functional Safety ◽  
Road Vehicles ◽  
Effect Analysis ◽  
Automotive Safety ◽  
Safety Requirements ◽  
Assessment Approach

ISO26262: 2018 is an international functional safety standard for electrical and/or electronic (E/E) systems within road vehicles. It provides appropriate safety requirements for road vehicles to avoid unreasonable residual risk according to automotive safety integrity levels (ASILs) derived from hazard analysis and risk assessment (HARA) required in the ISO26262 concept phase. Systems theoretic process analysis (STPA) seems to be designed specifically to deal with hazard analysis of modern complex systems, but it does not include risk evaluation required by most safety related international standards. So we integrated STPA into Failure Mode and Effect Analysis (FMEA) template to form a new method called system theoretic process analysis based on an FMEA template, STPAFT for shot, which could not only meet all the requirements of the concept phase in ISO26262, but also make full use of the advantages of the two methods. Through the focus of FMEA on low-level components, STPAFT can obtain more detailed causal factors (CFs), which is very helpful for derivation of safety goals (SGs) and the functional safety requirements (FSRs) in the concept phase of ISO26262. The application of STPAFT is described by the case study of fuel level estimation and display system (FLEDS) to show how the concept phase of ISO26262 could be supported by STPAFT.

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