Auswahl der wissenschaftlichen Literatur zum Thema „European Technical Approval Guidelines“

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Zeitschriftenartikel zum Thema "European Technical Approval Guidelines"

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Volkwein, Axel, Werner Gerber, Johannes Klette und Georg Spescha. „Review of Approval of Flexible Rockfall Protection Systems According to ETAG 027“. Geosciences 9, Nr. 1 (18.01.2019): 49. http://dx.doi.org/10.3390/geosciences9010049.

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In 2009, the European Guideline for Flexible Rockfall Protection Kits European Technical Approval Guideline 027 (ETAG 027) became valid. The aim of the guideline was to approve and certify steel barriers available on the market according to a common standard. In 2018, ETAG 027 was replaced by a so-called European Assessment Document (EAD). This contribution summarizes results and experiences that were obtained through the type testing, approval and assessment procedures of 66 protection systems evaluated between 2009 and 2018. Apart from the common main task of the barriers to stop falling blocks successfully, the different test conditions and constructions of barriers result in different performance characteristics. Some of these characteristics follow certain trends, whereas others show a wide range without any trend. In such a case, this contribution helps to classify a single system compared to the others.
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Peila, D., und C. Ronco. „Technical Note: Design of rockfall net fences and the new ETAG 027 European guideline“. Natural Hazards and Earth System Sciences 9, Nr. 4 (29.07.2009): 1291–98. http://dx.doi.org/10.5194/nhess-9-1291-2009.

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Abstract. The need for protection against rockfall has led to the development of different types of technological solutions that are able to both prevent blocks from detaching from rock walls and to control, intercept or deviate the blocks during movement. Of the many devices that are able to intercept and stop a block, one of the most frequently used is net fence. Many different types of full-scale tests have been carried out, with different test site geometries and procedures to study their behaviour and to certify these devices. This has led to a series of data and information that are not easy to compare. The recent endorsement, by the European Organization for Technical Approvals (EOTA), of a European Technical Approval Guideline (ETAG), which defines how to test and assess the performance of a net fence, is therefore a great innovation that will change both the market and the design procedures of these devices. The most important innovations introduced by this new guideline are here presented and discussed and a net fence design procedure for protection against rockfall is provided.
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Trad, Ayman, Ali Limam und Philippe Robit. „Real Scale Experiments on Rockfall Protection Barriers“. Applied Mechanics and Materials 82 (Juli 2011): 734–39. http://dx.doi.org/10.4028/www.scientific.net/amm.82.734.

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In the rockfall protection barriers, the role of the net is to diffuse the efforts to the braking devices which absorb the energy and slow down the velocity of the block. An innovative braking device working by the buckling of metallic tubes is developed by quasi-static and dynamic tests. Real scale experiments on the entire structure are done and presented here. These tests are performed as the recommendations of the new Guideline for European Technical Approval concerning the falling rock protection kits, named ETAG 27.
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Serrano-Aguilar, Pedro, José Asua-Batarrita, María Teresa Molina-López, Mireia Espallargues, Joan Pons-Rafols, Sandra García-Armesto, Paloma Arriola-Bolado et al. „The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS)“. International Journal of Technology Assessment in Health Care 35, Nr. 03 (2019): 176–80. http://dx.doi.org/10.1017/s0266462319000205.

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AbstractEarlier activities on health technology assessment (HTA) started in Spain around 1984, with the creation of a National Advisory Board on HTA, and the development of national and regional HTA organizations in the early 1990s. In 2012, the Spanish Health Ministry established the Spanish Network for Health Technology Assessment of the National Health System (RedETS); funded at national level and including all public HTA organizations at national and regional levels. RedETSis focused on the assessment of nondrug health technologies to inform the revision (approval and funding or disinvestment) of the Benefit Portfolio of the Spanish NHS. In parallel with European Network for Health Technology Assessment (EUnetHTA), RedETS has been setting-up and sharing common procedures and methodological guidelines to ensure effective cooperation and mutual recognition of the scientific and technical production in HTA. The output of RedETS is fifty to sixty annual reports, including the production of full HTA reports, Clinical Practice Guidelines, methodological guidance reports, relative effectiveness assessments, tools to support shared decision making between patients and healthcare professionals, and monitoring studies. The HTA assessments requested by the Regional Health Authorities are the biggest component of the annual RedETS working plan. These assessment needs are identified according to a yearly process and prioritized by a Commission composed of representatives from all Spanish regions with the aid of the PRITEC tool. The objectives of this study are to report and update the normative and organizational state of HTA in Spain; describing noteworthy advances witnessed over the past 10 years, as well as discussing existing challenges.
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Farenyuk, G. G., und O. B. Oleksiienko. „ANALYSIS CRITERIA FOR EVALUATION OF EUROPEAN EXPERIENCE FACADE SYSTEMS“. Bulletin of Odessa State Academy of Civil Engineering and Architecture, Nr. 80 (03.09.2020): 150–61. http://dx.doi.org/10.31650/2415-377x-2020-80-150-161.

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Abstract. Strategic problem of ensuring the update of energy profile of residential and public buildings may be solved if only recent design concept of facade thermal insulation is applied. As the design concept, facade thermal insulation appeared in reconstruction of buildings and structures. In domestic construction practice, this design concept is also widely used in new structures and that is why the system of criteria that determine the possible reduce of specific heat loss in heating of buildings should be updated, and the desired operational heat safety of buildings should be ensured. The paper deals with the development and implementation of new criteria for assessment of façade insulation systems with rendering, addresses the European experience and features the implementation of European standards in the national regulatory framework. The paper follows the previous research conducted by the State Research Institute of Building Constructions for the last fifteen years with main scientific papers being referenced and aimed at the development of methodological base for system of norms and standards that ensure the implementation of innovations in the practice of domestic construction sector. The paper covers the details of conformity assessment and suitability for use of facade thermal insulation in accordance with the methodological principles applied both in Ukraine and countries of European Community. The paper provides the analysis of the requirements set for facade thermal insulation with rendering by a national regulative document, DSTU B V.2.6-36:2008, and compares the requirements for ETICS (Exterior Thermal Insulation Composite System) set by Guideline for European Technical Approval of Exterior Thermal Insulation Composite System with Rendering (ETICS), ETAG 004.
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Laforce, Robert, Pedro Rosa-Neto, Jean-Paul Soucy, Gil D. Rabinovici, Bruno Dubois und S. Gauthier. „Canadian Consensus Guidelines on Use of Amyloid Imaging in Canada: Update and Future Directions from the Specialized Task Force on Amyloid imaging in Canada“. Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques 43, Nr. 4 (26.02.2016): 503–12. http://dx.doi.org/10.1017/cjn.2015.401.

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AbstractPositron emission tomography (PET) imaging of brain amyloid beta is now clinically available in several countries including the United States and the United Kingdom, but not Canada. It has become an established technique in the field of neuroimaging of aging and dementia, with data incorporated in the new consensus guidelines for the diagnosis of Alzheimer disease and predementia Alzheimer’s disease–related conditions. At this point, there are three US Food and Drug Administration– and European Union–approved tracers. Guided by appropriate use criteria developed in 2013 by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging, the utility of amyloid imaging in medical practice is now supported by a growing body of research. In this paper, we aimed to provide an update on the 2012 Canadian consensus guidelines to dementia care practitioners on proper use of amyloid imaging. We also wished to generate momentum for the industry to submit a new drug proposal to Health Canada. A group of local, national, and international dementia experts and imaging specialists met to discuss scenarios in which amyloid PET could be used appropriately. Peer-reviewed and published literature between January 2004 and May 2015 was searched. Technical and regulatory considerations pertaining to Canada were considered. The results of a survey of current practices in Canadian dementia centers were considered. A set of specific clinical and research guidelines was agreed on that defines the types of patients and clinical circumstances in which amyloid PET could be used in Canada. Future research directions were also outlined, notably the importance of studies that would assess the pharmaco-economics of amyloid imaging.
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R. Zeltser. „Institutional environment as a precondition for improving the technological progress of construction“. Ways to Improve Construction Efficiency, Nr. 45 (16.10.2020): 46–56. http://dx.doi.org/10.32347/2707-501x.2020.45.46-56.

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The legislation of Ukraine on the regulation of urban planning activities establishes the legal and organizational foundations of urban planning activities, which are aimed at ensuring sustainable development of territories, taking into account State, public and private interests. In accordance with the legislative acts, a number of government decrees, orders of the Ministry of Development of Communities and Territories of Ukraine (formerly - the Ministry of Regional Development of Ukraine), state building codes (new or amended from among the current ones) have been developed. There is an urgent need to analyze the situation and further improve the legal regulation of construction, including permitting and approval procedures for the organization and management of construction in accordance with legislation and regulations, adaptation of regulatory policy to European standards as a prerequisite for improving organizational and technological processes of construction and determining their effectiveness.Based on this goal, the following set of issues is consistently considered: contractual relations in capital construction; main participants in the construction - the customer and contractor, investor, developer, etc .; conditions for concluding a contract; terms of performance of works (construction of object); calendar schedule of works; contract price and estimated cost of construction; types of contracts and their characteristics; the rights of the customer and the contractor; contracts for design and research work; methods of economic evaluation of options for the organization of technological processes of construction.Currently, work is underway to improve the legislation on the organization of construction activities, namely: architectural and construction control and supervision, permitting procedures in construction, licensing, self-regulation in urban planning, electronic systems and BIM-technology, technical regulation in construction and more. In this regard, the current guidelines will be clarified with the release of new laws and regulations.
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ФАРЕНЮК, Г. Г., und О. Б. ОЛЕКСІЄНКО. „АНАЛІЗ КРИТЕРІЇВ ОЦІНКИ ФАСАДНИХ КОНСТРУКТИВНИХ СИСТЕМ ЗІ ШТУКАТУРНИМ ШАРОМ“. Наука та будівництво 26, Nr. 4 (12.02.2021): 3–14. http://dx.doi.org/10.33644/scienceandconstruction.v26i4.1.

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Вирішення стратегічного завдання із забезпечення зміни енергетичного статусу житлових та громадських будівель можливе тільки при застосуванні сучасних конструктивних рішень фасадної теплоізоляції. Як конструктивна система фасадна теплоізоляція виникла при реконструкції будівель і споруд, у вітчизняній будівельній практиці. Ці конструктивні рішення широко застосовуються і у новому будівництві, що обумовлює необхідність удосконалення системи критеріїв, які визначають можливість зниження питомих тепловтрат на опалення будинків з одночасним забезпеченням необхідної теплової надійності конструкцій під час експлуатації. У статті наводиться аналіз розробки та впровадження нових критеріїв оцінки фасадних систем зі штукатурним шаром з урахуванням європейського досвіду, розглядаються особливості імплементації європейських стандартів унаціональне нормативне поле. Стаття є продовження попередніх наукових робіт, що здійснюються у ДП НДІБК на протязі останніх п’ятнадцяти років направлені на розробку методологічних основ при створенні системи норм та стандартів, що забезпечує впровадження сучасних інноваційних технічних рішень у практику вітчизняного будівництва. В статті розглянуто особливості здійснення оцінки відповідності та визначення придатності застосування конструкцій фасадної теплоізоляції згідно методологічних принципів, що існують в Україні та країнах Європейської спільноти. У статті аналізуються вимоги, що встановлюються для конструкцій фасадної теплоізоляції з опорядженням штукатурками національним нормативним документом – ДСТУ Б В.2.6-36:2008 «Конструкції зовнішніх стін із фасадною теплоізоляцією та опорядженням штукатурками», та для цих конструкцій -згідно європейській термінології ETICS (Exterior Thermal Insulation Composite System), що встановлюються настановою з європейських технічнихухвалень та визначення придатності для застосування ETAG 004 «Guideline for European technical approval of external thermal insulation compositesystems with rendering».
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Al-Abbadi, Mousa A., Helena Barroca, Beata Bode-Lesniewska, Maria Calaminici, Nancy P. Caraway, David F. Chhieng, Immacolata Cozzolino et al. „A Proposal for the Performance, Classification, and Reporting of Lymph Node Fine-Needle Aspiration Cytopathology: The Sydney System“. Acta Cytologica 64, Nr. 4 (2020): 306–22. http://dx.doi.org/10.1159/000506497.

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Background: The evaluation of lymph nodes (LN) by fine-needle aspiration cytology (FNAC) is routinely used in many institutions but it is not uniformly accepted mainly because of the lack of guidelines and a cytopathological diagnostic classification. A committee of cytopathologists has developed a system of performance, classification, and reporting for LN-FNAC. Methods: The committee members prepared a document that has circulated among them five times; the final text has been approved by all the participants. It is based on a review of the international literature and on the expertise of the members. The system integrates clinical and imaging data with cytopathological features and ancillary techniques. The project has received the endorsement and patronage of the International Academy of Cytology and the European Federation of the Cytology Societies. Results: Clinical, imaging, and serological data of lymphadenopathies, indications for LN-FNAC, technical procedures, and ancillary techniques are evaluated with specific recommendations. The reporting system includes two diagnostic levels. The first should provide basic diagnostic information and includes five categories: inadequate/insufficient, benign, atypical lymphoid cells of undetermined/uncertain significance, suspicious, and malignant. For each category, specific recommendations are provided. The second diagnostic level, when achievable, should produce the identification of specific benign or malignant entities and additional information by utilizing ancillary testing. Conclusion: The authors believe that the introduction of this system for performing and reporting LN-FNAC may improve the quality of the procedure, the report, and the communication between cytopathologists and the clinicians. This system may lead to a greater acceptance and utilization of LN-FNAC and to a better interdisciplinary understanding of the results of this procedure.
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Vincent, Flavien, Julien Ternacle, Tom Denimal, Mylène Shen, Bjorn Redfors, Cédric Delhaye, Matheus Simonato et al. „Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Stenosis“. Circulation 143, Nr. 10 (09.03.2021): 1043–61. http://dx.doi.org/10.1161/circulationaha.120.048048.

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After 15 years of successive randomized, controlled trials, indications for transcatheter aortic valve replacement (TAVR) are rapidly expanding. In the coming years, this procedure could become the first line treatment for patients with a symptomatic severe aortic stenosis and a tricuspid aortic valve anatomy. However, randomized, controlled trials have excluded bicuspid aortic valve (BAV), which is the most frequent congenital heart disease occurring in 1% to 2% of the total population and representing at least 25% of patients 80 years of age or older referred for aortic valve replacement. The use of a less invasive transcatheter therapy in this elderly population became rapidly attractive, and approximately 10% of patients currently undergoing TAVR have a BAV. The U.S. Food and Drug Administration and the “European Conformity” have approved TAVR for low-risk patients regardless of the aortic valve anatomy whereas international guidelines recommend surgical replacement in BAV populations. Given this progressive expansion of TAVR toward younger and lower-risk patients, heart teams are encountering BAV patients more frequently, while the ability of this therapy to treat such a challenging anatomy remains uncertain. This review will address the singularity of BAV anatomy and associated technical challenges for the TAVR procedure. We will examine and summarize available clinical evidence and highlight critical knowledge gaps regarding TAVR utilization in BAV patients. We will provide a comprehensive overview of the role of computed tomography scans in the diagnosis, and classification of BAV and TAVR procedure planning. Overall, we will offer an integrated framework for understanding the current role of TAVR in the treatment of bicuspid aortic stenosis and for guiding physicians in clinical decision-making.
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Dissertationen zum Thema "European Technical Approval Guidelines"

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Gustafsson, Johan, und Jakob Myhrberg. „Expansion Joints in timber bridges : Mechanical behavior under external loading“. Thesis, Linnéuniversitetet, Institutionen för byggteknik (BY), 2021. http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-105321.

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To design a bridge, different typologies of construction materials can be used. All materials have in common that deformations occur due to different events, such as externalloading, temperature- and moisture variations. To allow these kinds of deformations,Expansion Joints (EJs) are used in the structure. In timber bridges, these joints haveturned out to be a complex construction detail, due to problems related to their strengthand moisture capacity. The purpose of this thesis is to overview design codes and tostudy the mechanical behavior of Nosing EJs in a roadway timber bridge under externalloading. The aim is to identify critical actions and provide an alternative design of thestudied EJ. The aim is also to create a Finite Element (FE) model of the EJs and carryout calculations according to the design codes. To achieve this, literature studies, designcalculations and FE-simulations were performed. It turned out that there were lack ofearlier studies within this field. Therefore, studies which treats EJs in bridges with othermaterial than timber were considered. The results from the simulations indicated thatthe steel components in EJs are the most exposed parts in the detail. It also turned outthat an eventual failure can transferred away from the screws to the parts consideredmore favorable in the EJ.
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Sillman, C. R. „Validation of post-installed anchors tested to European technical approval guideline 001 in South African concrete using portable test equipment“. Thesis, 2012. http://hdl.handle.net/10210/4801.

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M. Phil.
The purpose of this research is to see if on-site portable pull-out tests in South Africa on post-installed chemical and mechanical fixings can produce similar results to internationally laboratory tested fixings. The method used in the field study was to use typical South African 25 MPa, 75 mm slump ready mix concrete as supplied by a reputable supplier and to test several types of fixings in common situations, some covered in the European Technical Approval Guidelines (ETAG) and some not. The results were analyzed against published international values and theoretical calculations for the fixings. The findings showed that the results produced using the portable equipment can show values similar to the published and theoretical values. It was also shown that this methodology can be used as a diagnostic tool to reveal installation errors. The pull-out test operator needs to be skilled to ensure a satisfactory outcome of the tests. The implications of the findings have direct bearing on: The on-site pullout testing of post installed anchors in South Africa; The diagnosing of bad anchor installation. And secondarily bearing on: The education of post-installed fixing installers and designers; The lack of standards for post-installed anchors in South Africa; The transportability of data from international research to South African conditions.
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Bücher zum Thema "European Technical Approval Guidelines"

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Great Britain. Department of Transport. How to import a vehicle permanently into Great Britain: A guide to the technical requirements that need to be met before vehicles can be used on roads in Great Britain : European and national type approval : single vehicle approval : procedures for licensing and registration. London: HMSO, 1998.

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Caporali, Enrica, und Vladimir Trajkovik, Hrsg. ViCES - Video Conferencing Educational Services Main Project Outcomes. Florence: Firenze University Press, 2012. http://dx.doi.org/10.36253/978-88-6655-118-8.

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This e-book has been developed as result of the Video Conference Educational Service (ViCES) project under the TEMPUS action of the European Commission (144650-TEMPUS-2008-IT-JPGR. It is intended to serve as a set of guidelines for the setup and usage of videoconference tools in educational and vocational training institutions. It also offers suggestions to: companies, agencies and institutions that plan to introduce video conferencing based training experiences. The e-book covers both technical and organizational issues related to video conferencing educational services, such as: Learning Methodology Guideline, Non functional Requirements Recommendation, Organizational Structure & Business Processes Recommendation, Service Level Agreement Recommendation, Video Conferencing Service Sustainability Strategy, and Video Conferencing end Station Basic Tutorial.
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Redmill, F. J. Dependability of Critical Computer Systems 1: Guidelines Produced by the European Workshop on Industrial Computer Systems, Technical Committee 7 (Ew). Elsevier Applied Science, 1988.

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Felix, Redmill, Bishop P. G und European Workshop on Industrial Computer Systems. TC7--Systems Reliability, Safety, and Security., Hrsg. Dependability of critical computer systems: Guidelines produced by the European Workshop on Industrial Computer Systems, Technical Committee 7 (EWICS TC7). London: Elsevier Applied Science, 1988.

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Schweitzer, Stuart O., und Z. John Lu. Pharmaceutical Regulation in the European Union. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780190623784.003.0014.

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The main scientific and technical aspects of new drug registration, including pathways to marketing authorization approval, clinical study design and method, and requirement of and specifications for Good Clinical Practice, Good Laboratory Practice, and Good Manufacturing Practice, are all quite similar between Europe and the United States. Differences do exist, however. This chapter provides a closer examination of the drug regulatory regime in the European Union. After providing a brief history of the European Medicines Agency, the chapter examines the agency’s organizational structure and role in ensuring the safety and efficacy of pharmaceutical products for Europe, and discusses the regulatory pathways for generics and biosimilars in the EU. The chapter also looks at recent trends in international drug approval lags.
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Dalvinder, Singh. 1 Recovery and Resolution Planning: Reconfiguring Financial Regulation and Supervision. Oxford University Press, 2016. http://dx.doi.org/10.1093/law/9780198754411.003.0001.

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This chapter analyses the impact of recovery and resolution planning on the regulation and supervision of financial institutions. It argues that recovery and resolution planning places issues associated with crisis prevention and resolvability at the forefront of regulation and supervision rather than at the tail end. However, one challenge associated with this requirement is the level of discretion authorities have with regards to the technical requirements associated with formulating and reviewing the plans. The chapter explores the extent to which that discretion is structured and assisted by the introduction of European Banking Authority guidelines and technical standards. It concludes with a reflection of how recovery and resolution planning is likely to improve forward-looking risk-based supervision.
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Curcio, Domenico, Igor Gianfrancesco, Corrado Meglio, Simone Trentini, Alina Preger und Annalisa Pansini. Rischio di tasso di interesse del portafoglio bancario (IRRBB): evoluzione normativa ed implicazioni gestionai. AIFIRM, 2021. http://dx.doi.org/10.47473/2016ppa00025.

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The AIFIRM Commission on the interest rate risk in the banking book (IRRBB) has been established in a period of significant changes in the related prudential supervisory framework, which started in April 2016 with the publication of Basel Committe on Banking Supervision (BCBS)’s new standards. BCBS confirmed the secondpillar classification of IRRBB and introduced changes in its measurement approach. European regulation has already partially adopted these standards; the European Banking Authority (EBA) will issue specific technical standards and update its guidelines by March 2022. The Commission has firstly analyzed the most significant aspects of the recent changes in IRRBB-related regulation, assessing the potential impacts on models, processes and banks’ exposure to IRRBB. Following this analysis, the Commission has developed operational proposals that intend to provide support to individual risk managers and their structures in measuring, controlling and managing IRRBB and in adapting bank processes to the new regulatory requirements.
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Buchteile zum Thema "European Technical Approval Guidelines"

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Adam, Zulfiquar, und Mark A. de Belder. „Primary percutaneous coronary intervention for ST-elevation myocardial infarction“. In Oxford Textbook of Interventional Cardiology, herausgegeben von Simon Redwood, Nick Curzen und Adrian Banning, 251–72. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198754152.003.0017.

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This chapter covers primary percutaneous coronary intervention (PPCI), with an investigation of the limitations of the competing thrombolysis procedure, optimal timing, and a discussion of the technical aspects associated with delivering PPCI. Comparing randomized trials that look at differential outcomes in both the short and long term, and covering the European Society of Cardiology guidelines for ST-elevation myocardial infarction treatment, the chapter provides an overview and analysis of the risks and benefits of PPCI.
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Kieser, Teresa M., und Gabriele Di Giammarco. „Intraoperative graft assessment with transit-time flow measurement and epicardial ultrasound“. In State of the Art Surgical Coronary Revascularization, herausgegeben von Joseph F. Sabik, Stuart J. Head und Vipin Zamvar, 343–48. Oxford University Press, 2021. http://dx.doi.org/10.1093/med/9780198758785.003.0059.

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Intraoperative bypass graft evaluation for coronary artery bypass graft surgery has now been recommended in three consecutive European guidelines for myocardial revascularization in 2010, 2014, and 2018. The two main modalities consist of transit-time flow measurement which assesses function of grafts and epicardial ultrasound to assess the anatomy of the anastomosis. Functional and morphological assessment are generally considered complementary, although transit-time flow measurement is the most commonly used. Transit-time flow measurement alone may have ambiguous values in 5–15% of grafts and this can lead to unnecessary graft revision. The addition of epicardial ultrasound aids interpretation of intraoperative graft assessment by allowing visualization of the anastomosis and correction of technical errors that, intuitively, will lead to improved patient outcomes.
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Grimaldo, Francisco, Francisco Ródenas, Miguel Lozano, Stephanie Carretero, Juan Manuel Orduña, Jorge Garcés, José Duato und Enrique Fatas. „Design of an ICT Tool for Decision Making in Social and Health Policies“. In Handbook of Research on ICTs for Human-Centered Healthcare and Social Care Services, 802–19. IGI Global, 2013. http://dx.doi.org/10.4018/978-1-4666-3986-7.ch042.

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The governance requires technical support regarding the complexity in deciding health policies to assist people who require long-term care. Long-term care policies require the use of ICT simulation tools that can provide policy makers with the option of going into a decision theatre and virtually knowing the consequences of different policies prior to finally determining the real policy to be adopted. In this sense, there is an absence of simulation tools for decision making about long-term care policies. In this chapter, the authors propose the foundations and guidelines of SSIMSOWELL, a new scalable, multiagent simulation tool that increases the prediction capacity of governance in the long term care policies, improving the decision making in short, medium, and large term in different European regions. The simulation tool implements a previously validated Social Sustainability Model (SSM). The main goal of SSIMSOWELL is the prediction of policy impacts and the development of new governance models, since it increases the budgetary efficiency and the sustainability of long term policies. In addition, it improves the capacity of policy makers in modelling, planning, and evaluating social-health policies at different scales, ranges, and times in the European Union.
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Grimaldo, Francisco, Francisco Ródenas, Miguel Lozano, Stephanie Carretero, Juan M. Orduña, Jorge Garcés, José Duato und Enrique Fatas. „Design of an ICT Tool for Decision Making in Social and Health Policies“. In Healthcare Administration, 997–1014. IGI Global, 2015. http://dx.doi.org/10.4018/978-1-4666-6339-8.ch052.

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The governance requires technical support regarding the complexity in deciding health policies to assist people who require long-term care. Long-term care policies require the use of ICT simulation tools that can provide policy makers with the option of going into a decision theatre and virtually knowing the consequences of different policies prior to finally determining the real policy to be adopted. In this sense, there is an absence of simulation tools for decision making about long-term care policies. In this chapter, the authors propose the foundations and guidelines of SSIMSOWELL, a new scalable, multiagent simulation tool that increases the prediction capacity of governance in the long term care policies, improving the decision making in short, medium, and large term in different European regions. The simulation tool implements a previously validated Social Sustainability Model (SSM). The main goal of SSIMSOWELL is the prediction of policy impacts and the development of new governance models, since it increases the budgetary efficiency and the sustainability of long term policies. In addition, it improves the capacity of policy makers in modelling, planning, and evaluating social-health policies at different scales, ranges, and times in the European Union.
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Gatautis, Rimantas, Elena Vitkauskaite, Genadijus Kulvietis und Demetrios Sarantis. „e-Government Interoperability Framework in Lithuania“. In Interoperability in Digital Public Services and Administration, 62–78. IGI Global, 2011. http://dx.doi.org/10.4018/978-1-61520-887-6.ch004.

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An e-Government Interoperability Framework (eGIF) is one way to achieve e-Government interoperability. An eGIF is a set of standards and guidelines that a government uses to specify the preferred way that its agencies, citizens and partners interact with each other. In order to come up to the expectations of their stakeholders and to achieve real resolution of the evolving interoperability problems, the scope of the eGIFs needs to be extended, including service composition and discovery, development and management of semantic schemas for governmental documents, certification mechanisms and authentication standards. Moreover, a shift from a paper-based specification towards a repository of services, data schemas and process models is needed, in order to serve the ever-changing nature of governments under transformation. Upon conducting a state of the art analysis of relevant frameworks at a pan-European and national level, lessons learnt from the pioneers UK eGIF, German SAGA and Greek eGIF are presented. The proposed Lithuanian eGIF model describes new approach, outlines the technical, semantic and organization dimensions and stresses the importance of political interoperability. It also provides three layers model moving from only standards and specifications based approach to systems and coordination support elements. Finally the chapter tackles the issues that rose within stakeholders’ community in the e-Government interoperability context.
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Konferenzberichte zum Thema "European Technical Approval Guidelines"

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Brumovsky, Milan. „NTD ASI, Section IV: Evaluation of Residual Lifetime of Components and Piping in WWER Type NPPs“. In ASME 2018 Pressure Vessels and Piping Conference. American Society of Mechanical Engineers, 2018. http://dx.doi.org/10.1115/pvp2018-84139.

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VERLIFE – “Unified Procedure for Lifetime Assessment of Components and Piping in WWER NPPs during Operation” was initiated and co-ordinated by the Czech and was developed within the 5th Framework Program of the European Union in 2003 and later upgraded within the 6th Framework Program “COVERS – Safety of WWER NPPs” of the European Union in 2008. This Procedure had to fill the gap in original Soviet/Russian Codes and Rules for Nuclear Power Plants (NPPs) with WWER (Water-Water-Energetic-Reactor = PWR type) type reactors, as those codes were developed only for design and manufacture and were not changed since their second edition in 1989. VERLIFE Procedure is based on these Russian codes but incorporates also new developments in research, mainly in fracture mechanics, and also some principal approaches used in PWR codes. Last upgrading and principal extending of this VERLIFE Procedure was realized within the 3-years IAEA project (in close co-operation with another project of the 6th Framework Program of the European Union “NULIFE – Plant Life Management of NPPs”) that started in 2009 with final approval and editing in 2013. As all versions of the VERLIFE procedure were coordinated by the Czech and first version was based on the Czech version of the NTD ASI, there have been simultaneously incorporated into the Czech NTD ASI (Normative Technical Documentation of the Czech Association of Mechanical Engineers) guidelines that are accepted by the Czech State Office for Nuclear Safety for the use in evaluation of Czech NPPs. This document has several parts: Section IV – “Evaluation of Residual Lifetime of Components and Piping in WWER type NPPs” deals with the evaluation during NPP operation. Main part of the document is divided into four main parts: - Evaluation of resistance of components and piping against non-ductile failure - Evaluation of resistance of component and piping against fatigue damage, - Evaluation of resistance of components and piping against corrosion-mechanical damage - Evaluation of residual lifetime of components and piping with defects found during in-service inspections Additionally, several appendices are included for detailed description of individual parts of evaluation, e.g. - Determination of neutron fluences in reactor pressure vessel and internals - Determination of degradation of materials during operation - Requirements for evaluation of pressurized thermal shock regimes - Evaluation of corrosion-errosion effects in piping - Environmental fatigue evaluation - Evaluation of reactor pressure vessel failure probability Finally, the following appendices dealing with components integrity have been included: - Lifetime of reactor pressure vessel internals - Leak-before-break concept for WWER piping - No-break-zone for WWER piping The paper will describe structure and main principles of this Section IV.
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Barnard, Jason M. „Propagating ASME PCC-1 Appendix A Compliance“. In ASME 2016 Pressure Vessels and Piping Conference. American Society of Mechanical Engineers, 2016. http://dx.doi.org/10.1115/pvp2016-63228.

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In November 2013 the revised ASME PCC-1 “Guidelines for Pressure Boundary Bolted Joint Assembly” were published including Appendix A, “Training and Qualification of Bolted Joint Assembly Personnel.” This Appendix outlines a training, examination and qualification system for ensuring a consistent level of knowledge and experience for bolting assemblers and specialists working on bolted flange joint assemblies. The ultimate objective is a mobile workforce capable of bolting ASME plant with a minimum performance standard safely and with no subsequent leaks. Major operators and contractors involved in oil and gas, petrochemical and power generation, or any industry that uses bolted flange joint assemblies, can benefit from PCC-1. Benefit recognition has begun with operators now specifying PCC-1 compliance in their procedures and bid packages. However, nearly three years after the introduction of Appendix A the number of Qualifying Organizations approved to deliver the program and individuals qualified via these programs remains stubbornly small in comparison with other programs and insufficient to meet the future safety demands of the industry or the objective of PCC-1 and Appendix A. This technical paper reviews key elements of Appendix A, compares Appendix A with other international qualifications and suggests recommendations intended to increase recognition and compliance with these guidelines. The recommendations and expected benefits follow from an extensive review of work by other organizations and published data concerned to reduce recorded leaks from bolted joints, including: a) Implementation lessons learned from a Qualifying Organization and Review Organization. b) Current international qualifications and the differing routes to achieve each qualification including: 1) ASME PCC-1 Appendix A Training and Qualification of Bolted Joint Assembly Personnel. 2) European standard EN1591-4 Qualification of personnel competency in the assembly of the bolted connections of critical service pressurized systems. 3) Engineering Construction Industry Training Board (ECITB) Mechanical Joint Integrity (MJI) technical training standards and Step Change in Safety Mechanical Joint Integrity Route to Competence Guidance 4) Additional country specific qualifications c) Program effectiveness study of the Engineering Construction Industry Training Board (ECITB) Mechanical Joint Integrity (MJI) program and the Step Change in Safety Hydrocarbon Release (HCR) model set up to achieve leak reduction in the UK North Sea sector. Finally, the paper will conclude with outlining the benefits to be gained globally through standardization of international qualification programs to enable true portability including: a) The need to increase the number of auditable Qualifying Organizations able to deliver the program, qualify individuals and engage operator/contractors in the process. b) Importance of effective communication and summary of the guidelines.
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Moosmann, TM, C. Veraar, A. Frech, G. Ratzinger, B. Teuchner, G. Fraedrich und M. Schirmer. „FRI0338 Therapeutic conformity to guidelines and drug-approval in adamantiades-behcet's disease: a retrospective analysis of a middle-european cohort“. In Annual European Congress of Rheumatology, 14–17 June, 2017. BMJ Publishing Group Ltd and European League Against Rheumatism, 2017. http://dx.doi.org/10.1136/annrheumdis-2017-eular.5070.

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Medina, Lourdes A., Saylisse Dávila, Gül E. Okudan Kremer und Richard A. Wysk. „Design for FDA: A Predictive Model for the FDA’s Decision Time for Medical Devices“. In ASME 2013 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference. American Society of Mechanical Engineers, 2013. http://dx.doi.org/10.1115/detc2013-13606.

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The concept of Design for FDA (DfFDA) has a strong basis on the Food and Drug Administration’s (FDA) regulation for medical devices in the Unites States. In fact; an analysis of the factors that impact the time it takes the FDA’s to provide market approval for medical devices, the product design process model, and Design for X (DfX) methods with overlapping FDA objectives lead to the development of DfFDA as a means to increase awareness about regulatory compliance and promote designers to consider the regulations throughout the development process of medical devices. For doing so, the main objective of DfFDA is to provide regulation-focused guidelines to producers of medical devices. An important part of these guidelines and this paper’s major contribution is the development of a prediction model for the FDA’s decision time. Overall, we want this model to become a tool that allows medical device companies to come up with an accurate estimate of a product’s time-to-market after accounting for the FDA’s decision time. In this work, we provide a comparison and discussion on the adequacy of linear regression models and other non-linear models such as parallel and serial tree-based ensembles for prediction the FDA’s decision time.
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Cardoso, Ca´ssia, Luiz Fernando de Oliveira und Denise Faertes. „Development of the Risk Based Guidelines for Natural Gas Transmission Pipelines Projects“. In 2008 7th International Pipeline Conference. ASMEDC, 2008. http://dx.doi.org/10.1115/ipc2008-64262.

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The design standards of gas pipeline NBR 12712 and ASME B31.8, although having their own safety factors, had not incorporated explicitly the risk concept for the population in their definitions. However, the orientation of the Brazilian Environment Agencies is that the risk level of transportation activity for gas pipelines must be controlled to the health and the safety of the population. These facts can create a critical management situation because a gas pipeline can be in compliance with the design standards and not in relation to the criteria of the Environment Agencies. In this scenario, the establishment of risk based design guidelines becomes an essential action. In this article, a methodology for the elaboration of these guidelines is presented. We analyze not only the influences of the main operational and design parameters on the risk, but also the impact of the main risk acceptability criteria for the approval of the gas pipelines operation license. The result of this article is an excellent decision management tool on the management and the viability evaluation of this type of project and its application provides important technical knowledge to definitions of routes, operational and design parameters, and the optimized selection of risk reduction measures.
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Demetri, Kathyrn J., Terry L. Schulz und Bryan N. Friedman. „AP1000® Plant Adaptation To European Markets“. In 2014 22nd International Conference on Nuclear Engineering. American Society of Mechanical Engineers, 2014. http://dx.doi.org/10.1115/icone22-31057.

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The AP1000® plant is an 1100-MWe pressurized water reactor (PWR) with passive safety features and extensive plant simplifications that enhance construction, operation, maintenance and safety. One of the key design approaches in the AP1000 plant is to use passive features to mitigate design basis accidents. Active defense-in-depth (DiD) features provide investment protection, reduce the demands on the passive features and support the PRA. The passive features are classified as safety-related in the US. The active defense-in-depth features are classified as non-safety (with supplemental requirements) in the US. The AP1000 design has incorporated a standardization approach, which together with the level of safety achieved by the passive safety features, results in a plant design that can be applied to different geographical regions with varying regulatory standards and utility expectations without major changes. While the first deployments of the AP1000 plant are ongoing in China and the United States, Westinghouse has remained active in also pursuing European opportunities for the AP1000 plant. In particular, Westinghouse has cooperated for almost two decades with European utilities to ensure adaptation of the AP1000 plant to the European market. This cooperation has resulted in progress towards AP1000 plant deployment in European countries. The AP1000 plant is recognized worldwide and has been reviewed by regulators around the world, including China, the United Kingdom (UK), Canada as well as the US. The AP1000 PWR is the only Generation III+ reactor design to obtain final design approval from the United States Nuclear Regulatory Commission (US NRC) and interim approval from UK regulatory authorities as part of the Generic Design Assessment (GDA) process. It is the only technology to be licensed for construction in the United States in more than 30 years, and the only Generation III+ technology worldwide to receive an operating license, as well as construction approval in China. The AP1000 plant has been independently assessed and confirmed to meet the requirements of the European Utilities Requirements (EUR) document and the Electric Power Research Institute (EPRI) Advanced Light Water Reactor Utility Requirements Document (URD). The AP1000 plant has also been successfully assessed against multiple European industry guidelines such as the WENRA safety objectives, the IAEA safety standards, the ENSREG stress tests and the UK Weightman Report. In support of multiple ongoing request for proposal (RFP) and pre-RFP activities in European countries, Westinghouse has focused design effort and customer interactions in several European countries to adapt the AP1000 plant to European requirements. Review of the AP1000 plant design with regulators around the world, European Standards compliance activities, and continued cooperation and interaction with European Utilities provide confidence that the AP1000 plant can be successfully licensed and deployed in Europe. The AP1000 50Hz standard plant design (also referred to as European Passive Standard or EPS) is the resulting adaptation of the AP1000 60 Hz US standard plant design to European market needs and requirements, addressing both customer input from such programs as the European Passive Plant (EPP) program in addition to regulatory and Utility needs identified though RFP and pre-RFP activities. The AP1000 50Hz standard plant design retains the overall AP1000 plant design (safe, simple, standard), the use of proven components and its cost, safety and operability advantages, while incorporating some changes to adapt to the European environment. This paper will discuss some of the key changes that have been incorporated into the AP1000 50Hz plant design as necessary to adapt to the European market and demonstrate that the vast majority of the standard AP1000 plant design being built in China and the US is not impacted.
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Shaw, Jesse, und Sungon Kim. „Transfer of the DDG-51 Ship Service Gas Turbine Generator (SSGTG) Marine Electrical Power System Assembly and Installation to the Republic of Korea Navy KDX-III Destroyer Program“. In ASME Turbo Expo 2014: Turbine Technical Conference and Exposition. American Society of Mechanical Engineers, 2014. http://dx.doi.org/10.1115/gt2014-27082.

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In 2004, Rolls-Royce Naval Marine, Inc. (RRNMI, Walpole, MA, USA, now Rolls-Royce Marine North America, RRMNA) reached an agreement with Samsung Techwin Co. Ltd. (Seoul and Changwon, Korea) for the transfer of the assembly and installation of a marine electrical power system. This agreement culminated in the installation and use of Rolls-Royce Ship Service Gas Turbine Generators (SSGTGs) in the Republic of Korea Navy (RoKN) KDX-III Destroyers. In order to deliver success for this program, both companies had to overcome numerous technical and non-technical challenges. Among these challenges were: - Development of a kitting structure supplemented with tailored assembly drawings and instructions that could duplicate an established production process - Agreement on the amount of Korean labor and materials to be utilized, referred to as “in-country” content - Development of appropriate and necessary training for the assembly and testing of AG9140RF SSGTGs - Determination of a correlation factor which equalizes the variables between RRMNA’s engine test cell and Samsung Techwin’s engine test cell - Application of DAPA Quality Assurance (QA) requirements upon a system designed in accordance with US Navy QA requirements - Ensuring compliance with Export Control guidelines, Export License requirements, and Manufacturing License Agreements - Obtaining US Government approval for sale and transfer of technology and hardware to the Republic of Korea (RoK)
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Morra, Edoardo Pietro, Ezio Spessa und Mattia Venditti. „Optimization of the Operating Strategy of a BAS Hybrid Diesel Powertrain on Type-Approval and Real-World Representative Driving Cycles“. In ASME 2012 Internal Combustion Engine Division Spring Technical Conference. American Society of Mechanical Engineers, 2012. http://dx.doi.org/10.1115/ices2012-81093.

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Hybrid Electric Vehicles (HEVs) can be considered one of the most promising ways of improving the sustainability of the road transport sector. They are equipped with an Internal Combustion Engine (ICE) coupled to an electro-mechanical system. This study has focused on a parallel-hybrid diesel powertrain featuring a high-voltage Belt Alternator Starter (BAS). This layout allows regenerative braking, Stop&Start, load point shift and electric power assistance to the ICE. However, a dedicated optimization of the operating strategy is required to exploit all the expected advantages of the considered HEV. The project has entailed the implementation of a zero-dimensional model of the hybrid powertrain in GT-Drive and Matlab environments. Genetic Algorithm (GA) based techniques have been used to define a novel benchmark operating strategy and to calibrate a real-time optimizer. The benchmark and real-time optimization approaches have been applied to reduce the total FC and NOx emissions as well as to diminish the local combustion noise peaks. Different mission profiles have been considered, i.e. the New European Driving Cycle (NEDC) and three Artemis driving routes. The results show the effectiveness of the proposed methods and the improvements obtained in fuel economy, NOx emissions and combustion noise.
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Brumovsky, Milan. „VERLIFE: Unified Procedure for Lifetime Assessment of Components and Piping in WWER NPPs During Operation—Updating and Further Development“. In ASME 2009 Pressure Vessels and Piping Conference. ASMEDC, 2009. http://dx.doi.org/10.1115/pvp2009-77392.

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VERLIFE – “Unified Procedure for Lifetime Assessment of Components and Piping in WWER NPPs during Operation” was developed within the 5th Framework Program of the European Union in 2003 and later upgraded within the 6th Framework Program project “COVERS – Safety of WWER NPPs” of the European Union in 2008. This Procedure has to fill the gap in original Soviet/Russian Codes and Rules for WWER type NPPs, as these codes were developed only for design and manufacture and were not changed since their second edition in 1989. VERLIFE Procedure is based on these Russian codes but incorporates also new developments in research, mainly in fracture mechanics, and also some principal approaches used in PWR codes. To assure that VERLIFE Procedure will remain a living document, new 3-year IAEA project (in close co-operation with another project 6th Framework Program of the European Union “NULIFE – Plant Life Management of NPPs”) has started in 2009. Within this project, upgrading/updating of the VERLIFE procedure is prepared together with the extension by following procedures: - Lifetime of reactor pressure vessel internals. - Leak-before-break concept for WWER NPPs. - No-break-zone for WWER NPPs. - Probabilistic approach for failure and lifetime assessment of WWER reactor pressure vessels and primary piping (including Risk-informed ISI). - Thermal fatigue evaluation. Final document, after its approval by expert groups of the IAEA and NULIFE, will be issued as “IAEA Guidelines for Integrity and Lifetime Assessment of Components and Piping in WWER NPPs”. The paper will describe these main principles and also future plans.
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Kwan, Pok-Wang, David R. H. Gillespie, Rory D. Stieger und Andrew M. Rolt. „Minimising Loss in a Heat Exchanger Installation for an Intercooled Turbofan Engine“. In ASME 2011 Turbo Expo: Turbine Technical Conference and Exposition. ASMEDC, 2011. http://dx.doi.org/10.1115/gt2011-45814.

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An intercooled turbofan engine has been proposed within NEWAC (New Aero Engine Core Concepts, an European Sixth Framework Programme) using lightweight heat exchangers. The requirement for compactness has led to the need for zigzag heat exchanger arrangement where the heat exchanger matrices are inclined to the cooling flows approaching them, but such an arrangement creates non-uniform mass flows through the cold fluid side intercooler ducting and the intercooler heat exchanger matrices. Design guidelines aimed at minimizing aerodynamic losses caused by the flow mal-distribution in such ducting is reported. Minimising the loss has the effect of optimising the heat transfer performance. Flow velocities and pressure distributions were measured experimentally in a simplified model of a heat exchanger and simulated in Computational Fluid Dynamics (CFD). Good agreement was found between measurement and predictions of the flow distribution in the cold fluid side intercooler ducting downstream of the heat exchanger matrices. A dominant jetting flow in the centre of each exit passage was identified as a source of aerodynamic loss. The CFD simulation has also shown that the main source of aerodynamic loss arises from the severe flow mal-distribution within the heat exchanger matrices. From these results, design guidelines are presented in this paper for the ducting, based on CFD studies on a series of simplified heat exchanger arrangement geometries.
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