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.

Study of steady state and transient EGR behaviour of a medium duty diesel engine

It is well known that accurate EGR control is paramount to controlling engine out emissions during steady state and transient operation of a diesel engine. The direct measurement of EGR is however non-trivial and especially difficult in engines with no external EGR control where the intake manifold CO2 levels can be measured more readily. This work studies the EGR behaviour in a medium duty diesel engine with a passive EGR rebreathing strategy for steady state and transient operation. High speed (response time ∼1ms) in-cylinder sampling using modified GDI valves is coupled with high frequency response analysers to measure the cyclic in-cylinder CO2, from which the EGR rate is deduced. It was found that controlling the EGR using the passive rebreathing strategy during certain combined speed and load transients is challenging, causing high smoke and NO emissions. The in-cylinder sampling method coupled with fast CO2 measurement (time constant ∼8ms) in the exhaust port gave insights about the EGR rate during these transients. The complex interaction of the manifold pressures, turbo-charger operation and trapped charge composition from the previous cycle simply can cause high dilution and therefore high smoke levels. The steady state variation of NO emissions with respect to EGR is also studied using a fast NO analyzer (time constant ∼2ms) in the exhaust port. Cyclic variation was found to be up to ±5% at some load conditions. © 2008 SAE International.

Particulate matter emission during start-up and transient operation of a spark-ignition engine

In order to understand why emissions of Particulate Matter (PM) from Spark-Ignition (SI) automobiles peak during periods of transient operation such as rapid accelerations, a study of controlled, repeatable transients was performed. Time-resolved engine-out PM emissions from a modern four-cylinder engine during transient load and air/fuel ratio operation were examined, and the results could be fit in most cases to a first order time response. The time constants for the transient response are similar to those measured for changes in intake valve temperature, reflecting the strong dependence of PM emissions on the amount of liquid fuel in the combustion chamber. In only one unrepeatable case did the time response differ from a first order function: showing an overshoot in PM emissions during transition from the initial to the final steady state PM emission level. PM emissions during controlled, motored start-up experiments show a peak at start-up followed by a period during which emissions are either relatively constant or drift somewhat. When the fuel injection and ignition are shut off, PM emissions also peak briefly, but rapidly decay to low levels. Qualitative implications on the study and modeling of PM emissions during transient engine operation are discussed. Copyright © 1999 Society of Automotive Engineers, Inc.

Innovation, the diesel engine and vehicle markets: Evidence from OECD engine patents

This paper uses a patent data set to identify factors fostering innovation of diesel engines between 1974 and 2010 in the OECD region. The propensity of engine producers to innovate grew by 1.9 standard deviations after the expansion of the car market, by 0.7 standard deviations following a shift in the EU fuel economy standard, and by 0.23 standard deviations. The propensity to develop emissions control techniques was positively influenced by pollution control laws introduced in Japan, in the US, and in the EU, but not with the expansion of the car market. Furthermore, a decline in loan rates stimulated the propensity to develop emissions control techniques, which were simultaneously crowded out by increases in publicly-funded transport research and development. Innovation activities in engine efficiency are explained by market size, loan rates and by (Organisation for Economic Cooperation and Development) diesel prices, inclusive of taxes. Price effects on innovation, outweigh that of the US corporate average fuel economy standards. Innovation is also positively influenced by past transport research and development. © 2014 Elsevier Ltd.

A detailed chemistry multi-cycle simulation of a gasoline fueled HCCI engine operated with NVO

A previously developed Stochastic Reactor Model (SRM) is used to simulate combustion in a four cylinder in-line four-stroke naturally aspirated direct injection Spark Ignition (SI) engine modified to run in Homogeneous Charge Compression Ignition (HCCI) mode with a Negative Valve Overlap (NVO). A portion of the fuel is injected during NVO to increase the cylinder temperature and enable HCCI combustion at a compression ratio of 12:1. The model is coupled with GT-Power, a one-dimensional engine simulation tool used for the open valve portion of the engine cycle. The SRM is used to model in-cylinder mixing, heat transfer and chemistry during the NVO and main combustion. Direct injection is simulated during NVO in order to predict heat release and internal Exhaust Gas Recycle (EGR) composition and mass. The NOx emissions and simulated pressure profiles match experimental data well, including the cyclic fluctuations. The model predicts combustion characteristics at different fuel split ratios and injection timings. The effect of fuel reforming on ignition timing is investigated along with the causes of cycle to cycle variations and unstable operation. A detailed flux analysis during NVO unearths interesting results regarding the effect of NOx on ignition timing compared with its effect during the main combustion. © 2009 SAE International.

Experimental investigation of a control method for SI-HCCI-SI transition in a multi-cylinder gasoline engine

In HCCI engines, the Air/Fuel Ratio (AFR) and Residual Gas Fraction (RGF) are difficult to control during the SI-HCCI-SI transition, and this may result in incomplete combustion and/or high pressure raise rates. As a result, there may be undesirably high engine load fluctuations. The objectives of this work are to further understand this process and develop control methods to minimize these load fluctuations. This paper presents data on instantaneous AFR and RGF measurements, both taken by novel experimental techniques. The data provides an insight into the cyclic AFR and RGF fluctuations during the switch. These results suggest that the relatively slow change in the intake Manifold Air Pressure (MAP) and actuation time of the Variable Valve Timing (VVT) are the main causes of undesired AFR and RGF fluctuations, and hence an unacceptable Net IMEP (NIMEP) fluctuation. We also found large cylinder-to-cylinder AFR variations during the transition. Therefore, besides throttle opening control and VVT shifting, cyclic and individual cylinder fuel injection control is necessary to achieve a smooth transition. The control method was developed and implemented in a test engine, and the result was a considerably reduced NIMEP fluctuation during the mode switch. The instantaneous AFR and RGF measurements could furthermore be adopted to develop more sophisticated control methods for SI-HCCI-SI transitions. © 2010 SAE International.

Modelling soot formation in a DISI engine

In this work, the formation of soot in a Direct Injection Spark Ignition (DISI) engine is simulated using the Stochastic Reactor Model (SRM) engine code. Volume change, convective heat transfer, turbulent mixing, direct injection and flame propagation are accounted for. In order to simulate flame propagation, the cylinder is divided into an unburned, entrained and burned zone, with the rate of entrainment being governed by empirical equations but combustion modelled with chemical kinetics. The model contains a detailed chemical mechanism as well as a highly detailed soot formation model, however computation times are relatively short. The soot model provides information on the morphology and chemical composition of soot aggregates along with bulk quantities, including soot mass, number density, volume fraction and surface area. The model is first calibrated by simulating experimental data from a Gasoline Direct Injection (GDI) Spark Ignition (SI) engine. The model is then used to simulate experimental data from the literature, where the numbers, sizes and derived mass particulate emissions from a 1.83 L, 4-cylinder, 4 valve production DISI engine were examined. Experimental results from different injection and spark timings are compared with the model and the qualitative trends in aggregate size distribution and emissions match the exhaust gas measurements well. © 2010 The Combustion Institute. Published by Elsevier Inc. All rights reserved.