An overview of guidance documents for software in metrological applications

Tasić, Tanasko; Grottker, Ulrich

doi:10.1016/j.csi.2005.07.012

Cited by 9 publications

(5 citation statements)

References 3 publications

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“…However, deciphering these requirements can be a difficult and onerous task as the requirements for traceability vary between the documents. The variation between the documents extends to other areas such that "In already developed guidance documents different software quality issues, software lifecycle phases and consequences of risk evaluation for software malfunction or fraud are addressed to different extents" [6]. This paper identifies the references to traceability within each of the relevant medical device standards and guidelines and defines the requirements for traceability during each stage of the software development lifecycle.…”

Section: Introductionmentioning

confidence: 99%

Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model

Regan

McCaffery

Daid

et al. 2013

Computer Standards & Interfaces

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Abstract. Developing safety critical software is a complex process. Due to the fact that medical device software failure can lead to catastrophic consequences, numerous standards have been developed which govern software development in the medical device domain. Risk management has an important role in medical device software development as it is important to ensure that safe software is developed. Demonstrating traceability of requirements right throughout the medical device software development and maintenance lifecycles is an important part of demonstrating that 'safe' software has been produced through adopting defined processes. Consequently, medical device standards and guidelines emphasise the need for traceability. This paper outlines the extent and diversity of traceability requirements within medical device standards and guidelines, and identifies the requirements for traceability through each phase of the software development lifecycle. The paper also summarises the findings obtained when a lightweight assessment method (MedTrace), that we created, based upon the traceability practices within these standards, was implemented in two SME organisations. Finally we highlight how the findings indicate a lack of guidance as to what is required when implementing and maintaining a traceability process.

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Section: Introductionmentioning

confidence: 99%

Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model

Regan

McCaffery

Daid

et al. 2013

Computer Standards & Interfaces

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“…The software is then validated to fulfill the requirement requested by standards [19][20][21][22] . The validation is conducted to verify the functionality by comparing the automatic and manual measurements [23][24][25] .…”

Section: Fig 6: Measurement Panelmentioning

confidence: 99%

Development of Automatic Calibration System for Solid-State DC Voltage Standards and Its Validation

Munir,

Azzumar,

Syahadi

et al. 2023

Evergreen

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A manual calibration system for the solid-state DC voltage standard has been established at the National Measurement Standard (SNSU-BSN). The manual calibration was timeconsuming, fatiguing, and difficult to collect data. To improve this measurement process, SNSU-BSN has developed an automatic calibration system for solid-state DC voltage standards using programmable software for data acquisition and a low thermal scanner for switching during the measurement. A differential measurement method is performed for automatic calibration system in 1.018 V and 10 V. This automatic calibration system has been validated with manual calibration mode for measurement repeatability in same environmental condition. The result shows that the standard uncertainties of repeatability for automatic and manual calibration at a nominal voltage of 1.018 V are 0.0035 μV and 0.0071 μV, and for a nominal voltage of 10 V are 0.090 μV and 0.038 μV, respectively. The normalized error (En number) values of nominal voltage 1.018 V and 10 V are less than 1, stating that the results of automatic and manual measurements are in good agreement. Therefore, the automatic measurement system can be applied to replace the manual process of measurement at SNSU-BSN since this method is faster and has better uncertainty values.

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“…In [12], approaches to software quality requirements and software testing methods are compared, and different approaches to software quality assessment in different international standards and guidelines, in particular on issues related to the quality assessment of MI software, are determined.…”

Section: Literature Review and Problem Statementmentioning

confidence: 99%

“…However, [11][12][13][14][15] do not provide a comparative analysis of the importance of the impact of specific characteristics of MI software on the overall result of the software quality assessment. The requirements of the international document [2] and the possibility of software application for local MI are not taken into account in [16][17][18].…”

Section: Literature Review and Problem Statementmentioning

confidence: 99%

Quality assessment of measurement instrument software with analytic hierarchy process

Velychko¹,

Hrabovskyi²,

Gordiyenko³

2019

EEJET

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An overview of guidance documents for software in metrological applications

Cited by 9 publications

References 3 publications

Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model

Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model

Development of Automatic Calibration System for Solid-State DC Voltage Standards and Its Validation

Quality assessment of measurement instrument software with analytic hierarchy process

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