Experience in capturing requirements for safety-critical medical devices in an industrial environment

2002 ◽  
Author(s):  
Wei-Tek Tsai ◽  
R. Mojdehbakhsh ◽  
S. Rayadurgam
Keyword(s):  
Medical Devices ◽  
Industrial Environment ◽  
Safety Critical

Rapid Pattern-Oriented Scenario-Based Testing for Embedded Systems

2011 ◽  
pp. 222-262 ◽  
Author(s):  
Wei-Tek Tsai ◽  
Ray Paul ◽  
Lian Yu ◽  
Xiao Wei
Keyword(s):  
Medical Devices ◽  
Rapid Test ◽  
Regression Testing ◽  
Safety Critical ◽  
Industrial Sites ◽  
Test Script ◽  
Software Changes ◽  
Development Processes ◽  
Key Features ◽  
Agile Process

Systems change often, and each change requires reverification and revalidation. Modern software development processes such as agile process even welcome and accommodate frequent software changes. Traditionally, software reverification and revalidation are handled by regression testing. This chapter presents a pattern-oriented scenario-based approach to rapidly reverify and revalidate frequently changed software. Key features of this approach are (1) classifying system scenarios into reusable patterns; (2) application of a formal completeness analysis to identify missing scenarios; (3) identifying scenario patterns (SPs) and corresponding verification patterns (VPs) and robustness patterns (RBPs); (4) rapid test script generation by reusing test script templates. This approach is also compatible with formal approaches such as model checking. This approach has been used at industrial sites to test safety-critical medical devices with significant savings in cost and effort. The chapter presents several examples to illustrate the effectiveness and efficiency of this approach.

scholarly journals Analysis of Safety-Critical Computer Failures in Medical Devices

2013 ◽  
Vol 11 (4) ◽  
pp. 14-26 ◽  
Author(s):  
Homa Alemzadeh ◽  
Ravishankar K. Iyer ◽  
Zbigniew Kalbarczyk ◽  
Jai Raman
Keyword(s):  
Medical Devices ◽  
Safety Critical

Ultrastructural changes in murine lymphoma cells exposed to ultraviolet-A radiation

1991 ◽  
Vol 49 ◽  
pp. 104-105
Author(s):  
Delma P. Thomas ◽  
Dianne E. Godar
Keyword(s):  
Medical Devices ◽  
Blood Cells ◽  
White Blood Cells ◽  
Consumer Products ◽  
Ultrastructural Changes ◽  
Ultraviolet A ◽  
Uv Spectrum ◽  
Lymphoma Cells ◽  
Murine Lymphoma ◽  
Transmission Electron

Ultraviolet radiation (UVR) from all three waveband regions of the UV spectrum, UVA (320-400 nm), UVB (290-320 nm), and UVC (200-290 nm), can be emitted by some medical devices and consumer products. Sunlamps can expose the blood to a considerable amount of UVR, particularly UVA and/or UVB. The percent transmission of each waveband through the epidermis to the dermis, which contains blood, increases in the order of increasing wavelength: UVC (10%) < UVB (20%) < UVA (30%). To investigate the effects of UVR on white blood cells, we chose transmission electron microscopy to examine the ultrastructure changes in L5178Y-R murine lymphoma cells.

Bacterial biofilm behavior in water-supply lines of dental units

1992 ◽  
Vol 50 (1) ◽  
pp. 882-883
Author(s):  
B.D. Tall ◽  
K.S. George ◽  
R. T. Gray ◽  
H.N. Williams
Keyword(s):  
Water Supply ◽  
Medical Devices ◽  
Biofilm Formation ◽  
Bacterial Biofilm

Studies of bacterial behavior in many environments have shown that most organisms attach to surfaces, forming communities of microcolonies called biofilms. In contaminated medical devices, biofilms may serve both as reservoirs and as inocula for the initiation of infections. Recently, there has been much concern about the potential of dental units to transmit infections. Because the mechanisms of biofilm formation are ill-defined, we investigated the behavior and formation of a biofilm associated with tubing leading to the water syringe of a dental unit over a period of 1 month.

Patients with chronic diseases: tomorrow, all sentinels?

2020 ◽  
Vol 12 (1) ◽  
pp. 10502
Author(s):  
Jean-David Cohen ◽  
Cyril Crozet ◽  
Jean-François d’Ivernois ◽  
Rémi Gagnayre
Keyword(s):  
Chronic Diseases ◽  
Experimental Research ◽  
Medical Devices ◽  
Clinical Experiences ◽  
Very Old ◽  
Quasi Experimental ◽  
External Measure

Very old studies and clinical experiences of physicians already signal the ability of some patients to feel subclinical signs. These patients are called sentinel patients because they can anticipate crisis very early and therefore intervene quickly to prevent them. Studies have shown that these patients develop these skills from their own experience, in steps which are similar to quasi-experimental research. They test and adjust their competence all the more easily as they have an objective external measure available. This faculty of patients suggests the possibility of using medical devices as a means of learning for patients to tutor themselves in support of this singular skill.

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