Designing for validation of medical devices and equipment

Validation is important in the design, development and production of medical devices since effective and appropriate validation plays a vital role in defining the success of a product in both technical and economic terms. Regulations and quality standards lay out the requirements for product validation, but it is left to each individual manufacturer to establish and maintain their own validation procedures. More recently, there has also been a change of emphasis in the regulations and standards that encourage the integration of validation into the development process. However, this poses particular challenges to the manufacturer since there is a distinct lack of guidance to assist this integration. This workbook provides the first real guidance on good design practices for medical device development. It has been developed through extensive consultation with device manufacturers and analysis of regulatory requirements. The approach is intended to assist manufacturers in meeting the new regulations.

Validation of Vision Tracking at Egnatia Odos Motorway

Tracking applications provide real time on-site information that can be used to detect travel path conflicts, calculate crew productivity and eliminate unnecessary processes at the site. This paper presents the validation of a novel vision based tracking methodology at the Egnatia Odos Motorway in Thessaloniki, Greece. Egnatia Odos is a motorway that connects Turkey with Italy through Greece. Its multiple open construction sites serves as an ideal multi-site test bed for validating construction site tracking methods. The vision based tracking methodology uses video cameras and computer algorithms to calculate the 3D position of project related entities (e.g. personnel, materials and equipment) in construction sites. The approach provides an unobtrusive, inexpensive way of effectively identifying and tracking the 3D location of entities. The process followed in this study starts by acquiring video data from multiple synchronous cameras at several large scale project sites of Egnatia Odos, such as tunnels, interchanges and bridges under construction. Subsequent steps include the evaluation of the collected data and finally, performing the 3D tracking operations on selected entities (heavy equipment and personnel). The accuracy and precision of the method's results is evaluated by comparing it with the actual 3D position of the object, thus assessing the 3D tracking method's effectiveness.

Modelling and validation of wet steam flow in a low pressure steam turbine

Results of numerical investigations of the wet steam flow in a three stage low pressure steam turbine test rig are presented. The test rig is a scale model of a modern steam turbine design and provides flow measurements over a range of operating conditions which are used for detailed comparisons with the numerical results. For the numerical analysis a modern CFD code with user defined models for specific wet steam modelling is used. The effect of different theoretical models for nucleation and droplet growth are examined. It is shown that heterogeneous condensation is highly dependent on steam quality and, in this model turbine with high quality steam, a homogeneous theory appears to be the best choice. The homogeneous theory gives good agreement between the test rig traverse measurements and the numerical results. The differences in the droplet size distribution of the three stage turbine are shown for different loads and modelling assumptions. The different droplet growth models can influence the droplet size by a factor of two. An estimate of the influence of unsteady effects is made by means of an unsteady two-dimensional simulation. The unsteady modelling leads to a shift of nucleation into the next blade row. For the investigated three stage turbine the influence due to wake chopping on the condensation process is weak but to confirm this conclusion further investigations are needed in complete three dimensions and on turbines with more stages. Copyright © 2011 by ASME.