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.

Using strong sustainability to optimize electricity generation fuel mixes

This work represents a contribution to the field of sustainable electricity system design by using an optimization tool to specify the final mix composition, subject to the constraints of: emissions that are within the biocapacity of the region; a diverse and robust electricity supply system; and supply that at least meets current demand. The 25-country European Union (EU-25) is used as a case study. All the goals, save diversity, can be met by re-structuring the current fuel mix, thus maintaining current consumption levels. The diversity target is only met when consumption is reduced by 10-15% and the constraint on maximum material throughput is relaxed. Re-structuring the mix and reducing consumption is insufficient to achieve a sustainable EU carbon footprint. However, the solution proposed singlehandedly allows the EU to meet its Kyoto emissions target as well as its 2007 policy of a reduction of 20% in greenhouse gas emissions by 2020. © 2007 Elsevier Ltd. All rights reserved.

Quantifying the limits of HANPP and carbon emissions which prolong total species well-being

Anthropogenic climate and land-use change are leading to irreversible losses of global biodiversity, upon which ecosystem functioning depends. Since total species' well-being depends on ecosystem goods and services, man must determine how much net primary productivity (NPP) may be appropriated and carbon emitted so as to not adversely impact this and future generations. In 2005, man ought to have only appropriated 9.72 Pg C of NPP, representing a factor 2.50, or 59.93%, reduction in human-appropriated NPP in that year. Concurrently, the carbon cycle would have been balanced with a factor 1.26, or 20.84%, reduction from 7.60 Gt C/year to 5.70 Gt C/year, representing a return to the 1986 levels. This limit is in keeping with the category III stabilization scenario of the Intergovernmental Panel for Climate Change. Projecting population growth to 2030 and its associated basic food requirements, the maximum HANPP remains at 9.74 ± 0.02 Pg C/year. This time-invariant HANPP may only provide for the current global population of 6.51 billion equitably at the current average consumption of 1.49 t C per capita, calling into question the sustainability of developing countries striving for high-consuming country levels of 5.85 t C per capita and its impacts on equitable resource distribution. © Springer Science+Business Media B.V. 2009.

Linking energy policy, electricity generation and transmission using strong sustainability and co-optimization

The design of a sustainable electricity generation and transmission system is based on the established science of anthropogenic climate change and the realization that depending on imported fossil-fuels is becoming a measure of energy insecurity of supply. A model is proposed which integrates generation fuel mix composition, assignment of plants and optimized power flow, using Portugal as a case study. The result of this co-optimized approach is an overall set of generator types/fuels which increases the diversity of Portuguese electricity supply, lowers its dependency on imported fuels by 14.62% and moves the country towards meeting its regional and international obligations of 31% energy from renewables by 2020 and a 27% reduction in greenhouse gas emissions by 2012, respectively. The quantity and composition of power generation at each bus is specified, with particular focus on quantifying the amount of distributed generation. Based on other works, the resultant, overall distributed capacity penetration of 19.02% of total installed generation is expected to yield positive network benefits. Thus, the model demonstrates that national energy policy and technical deployment can be linked through sustainability and, moreover, that the respective goals may be mutually achieved via holistic, integrated design. ©2009 IEEE.