Academic literature on the topic 'Medical instruments and apparatus Standards'
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Journal articles on the topic "Medical instruments and apparatus Standards"
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Jette, L. P., and N. G. Lambert. "Evaluation of Two Hot Water Washer Disinfectors for Medical Instruments." Infection Control & Hospital Epidemiology 9, no. 5 (May 1988): 194–99. http://dx.doi.org/10.1086/645832.
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AbstractTwo models of hot water washer disinfectors (Decomat 128 and Hospital A, Euroclean Canada Inc; Ontario, Canada) were evaluated by two methods for their efficacy in disinfecting anesthesia equipment. In the first method, three different microbial suspensions were each sealed into 30 capillary tubes. In the second method, corrugated anesthesia tubes were rinsed with suspensions of each of two bacterial strains. The tubes then underwent a standard cycle in the hot water washer disinfectors and were subsequently tested for growth of microorganisms. All experiments were repeated three times, and the temperature was registered in all cases. In the capillary test, growth was rarely detected (13/540 tubes) and the inactivation factor for both apparatus was > 5 log,,. In the rinse test, no growth was detected. The mean temperature for 15 disinfection cycles was 84.2 ± 0.8°C for Decomat 128 and 88.9 ± 0.5% for Hospital A. However, for Decomat 128 we observed a variation of 3°C from one disinfection cycle to another and a progressive reduction of 2.2°C over a series of five consecutive complete cycles. Both methods gave reproducible results. Under our experimental conditions, both hot water washer disinfectors proved to be efficacious for the disinfection of reusable anesthesia equipment.
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Lando, Hands, Sukri Palutturi, Amran Razak, Darmaw ansyah, Saifuddin Sirajuddin, and Muhammad Kardi. "Analysis of Determinants of the Logistics Management System of Medical Devices at the Wamena Regional General Hospital, Jayawijaya Regency." NeuroQuantology 20, no. 5 (May 2, 2022): 141–49. http://dx.doi.org/10.14704/nq.2022.20.5.nq22157.
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Functions and Roles of hospitals in addition to medical treatment also meet the requirements of location, buildings, infrastructure, and human resources, hospitals must also meet the requirements of pharmacy and equipment. Medical Devices are instruments, apparatus, machines and/or implants that do not contain drugs that are used to prevent, diagnose, cure and relieve disease, treat sick people, restore health in humans, and/or form structures and improve body functions. The purpose of this study was to determine the logistics management system for medical devices at the Wamena Regional General Hospital. This type of research is qualitative descriptive with in-depth interviews and document review involving 8 informants. The results of this study indicate that planning is made based on annual and routine meetings, procurement is based on unit needs, budgeting is based on RAB and APBD, no logistics warehouse storage, distribution is often long and late so users wait, standard maintenance and categorizes good and damaged goods, elimination carried out on unused goods due to damage, monitoring and evaluation are effective because the final part of the logistics management process is to maintain grade, quality and quantity.
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Manita, Aakash Deep, Vikram, Avtar C. Rana, and Prabodh C. Sharma. "Regulation and Clinical Investigation of Medical Device in the European Union." Applied Clinical Research, Clinical Trials and Regulatory Affairs 6, no. 3 (November 13, 2019): 163–81. http://dx.doi.org/10.2174/2213476x06666190821095407.
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Background:: Medical devices are the machine, tool, instrument, apparatus, implant, calibrator in vitro, software, the similar or related object intended for use by the manufacturer alone or in combination becoming increasingly important in the healthcare sector as these are used to diagnosis, control, prevention or treatment of an illness. Safety of the world population is the highest priority in order to launch new medical devices for the treatment and diagnostic of several diseases. New innovation in industries and regulations work together to provide devices for different world market and to improve quality and safety of exiting devices in the market. The main key for devices is to classify the determination of actual regulatory pathway which ensures the safety standards and other regulatory requirements in a specific country. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. For any high-risk devices, the new EU law states that the manufacturer has to prepare a complete summary for their evidence. The clinical trials regulation provides more transparency on clinical trials data. Complete transparency is required for the maximum possibility of informed decisions in order to use new medical devices. Objective:: The current manuscript will provide the information regarding the regulatory framework for the approval of medical devices and clinical investigation of medical device in European Union and comparison of approval process of medical device in USA, EU and India. The aim of this paper is to provide an overview of the most suitable and emerging requirements that manufacturers need for introducing their medical devices in the market in compliance with the MDR regulations. Conclusion:: The proposal for a modified regulation of medical devices aims to ensure more robust clinical data in support of the CE marking applications of the medical device. The clinical investigation requirements will be mandatory, and there will be an obligation to demonstrate the clinical benefits of the device and provide a rigorous equivalence test if the assessment is based on comparison devices. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized.
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Giarrizzo-Wilson, Sharon. "Collaborative instrumentation standards; fire protection standards; sterilizers; medical gas fittings; borrowing instruments." AORN Journal 82, no. 4 (October 2005): 673–78. http://dx.doi.org/10.1016/s0001-2092(06)60039-2.
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Vorogushin, V. A., T. V. Kustov, G. N. Pakharkov, and Z. M. Yuldashev. "Implementation of Professional Standards in Use of Medical Instruments." Biomedical Engineering 48, no. 2 (July 2014): 97–99. http://dx.doi.org/10.1007/s10527-014-9429-y.
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Баурина and Svetlana Baurina. "Standardization and Quality of Medical Equipment and Apparatus." Economics of the Firm 3, no. 2 (June 17, 2014): 8–12. http://dx.doi.org/10.12737/5989.
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Trends in medical-technical industry of Russia are discussed. Provided are
brief characteristics of quality indicators and review of requirements for
medical devices and equipment. The author describes basic standards,
governing regulatory requirements for medical equipment maintenance support
and quality management systems for medical equipment and apparatus
production.
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Zhang, Jin Liang. "Usage and Maintenance of Medical Apparatus and Instruments of Human Factors Research." Applied Mechanics and Materials 651-653 (September 2014): 1691–94. http://dx.doi.org/10.4028/www.scientific.net/amm.651-653.1691.
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Medical equipment maintenance and use of personnel, is crucial. Used properly and rational division of engineering and technical personnel, strict management, to train engineering technical personnel with professional spirit, all-round for clinical medical services; To strengthen the training of equipment use of personnel, highlight the preventive maintenance and maximize or prolonged trouble-free of medical instrument equipment, ensure the effective operation of the clinical diagnosis and treatment work.
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Levin, Sergey F. "The measurement problem of calibration of measuring instrument under specified conditions." Izmeritel`naya Tekhnika, no. 4 (2021): 9–15. http://dx.doi.org/10.32446/0368-1025it.2021-4-9-15.
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The problem of calibration of measuring instruments for given conditions based on the correction function is considered as a measurement problem of structural-parametric identification of the calibration diagram. It is shown, that the correction function allows at the first stage to obtain a ratio for correcting the readings, and at the second stage to obtain a corrected measurement result, it is necessary to identify the probability distribution of possible deviations from it. An example of solving the measurement problem of calibration for given conditions is given. Negative aspects of the practice of calibration of measuring instruments are noted: carrying out calibration under normal conditions according to the methods of verification of measuring instruments; presentation of calibration results by tables of joint readings of measuring instruments and standards; the presence in the calculations of the calibration diagram of significant restrictions on the mathematical apparatus of the «Guidelines for the expression of measurement uncertainty», specified by ISO/IEC 31010:2019 “Risk management – Risk assessment techniques”.
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Genuth, Sara Schechner. "Book Review: Nineteenth-Century Apparatus: Pike's Illustrated Catalogue of Scientific & Medical Instruments." Journal for the History of Astronomy 18, no. 2 (May 1987): 140–41. http://dx.doi.org/10.1177/002182868701800215.
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Van Lente, Eric, and Martin Power. "Standardising assessment instruments and care planning in Ireland." Quality in Ageing and Older Adults 15, no. 1 (March 4, 2014): 46–60. http://dx.doi.org/10.1108/qaoa-01-2013-0002.
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Purpose – Scoping of instruments in use for assessment of needs and the practices that surround care planning in residential care for older people in Ireland, in the wake of the introduction of national standards. The paper discusses these issues. Design/methodology/approach – Survey of care providers using an online/postal questionnaire, developed from the domains of need outlined in the standards. Findings – There is wide variation in the use of standardised instruments for assessment. Within some domains, standardised instruments enjoy near universal usage. However, within other domains, standardised instruments are often absent, external professional input and/or guidelines dominate and/or instruments have been adapted in-house. Practices surrounding care planning are largely homogeneous and the preserve of medical professionals. Research limitations/implications – This research was confined to the Republic of Ireland, limiting generalisation. The self-selecting nature of participants must also be considered. Further research could include, examining how, over time, the standards are shaping care practice, particularly in relation to interdisciplinary working and person-centred care. Practical implications – The non-prescriptive nature of the standards presents a challenge to care providers in selecting appropriate standardised instruments for assessment. In addition, medical dominance of care planning limits the extent to which care plans can enhance the provision of interdisciplinary and person-centred care. Originality/value – This paper contributes to a growing literature on standardisation of assessment and care planning, provides a reference point for comparison with other nations and, in an Irish context, addresses an area that has received little attention to-date. As such, it is of interest to practitioners, care providers and regulators.
Dissertations / Theses on the topic "Medical instruments and apparatus Standards"
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Krzyuy, Ariadne Maria. "Estudo comparativo das aplicações dos objetos de teste Eurospin e American College of Radiology no controle de qualidade em ressonância magnética." Universidade Tecnológica Federal do Paraná, 2015. http://repositorio.utfpr.edu.br/jspui/handle/1/1179.
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A Ressonância Magnética (RM) é um método de diagnóstico por imagem que apresenta vantagens em relação aos demais métodos, o que fez com que o número de equipamentos instalados nos grandes centros brasileiros aumentasse 88% nos últimos 5 anos e cerca de 508% nos últimos 15 anos, o que demonstra a importância dessa modalidade como meio de diagnóstico por imagem. Para garantir uma imagem médica com qualidade diagnóstica, é necessário que os equipamentos sejam monitorados quanto à qualidade das imagens que produzem. Por isso, com o objetivo de manter a qualidade das imagens médicas em seu mais alto nível e assegurar o bom funcionamento dos equipamentos, é que são implementados programas de Controle de Qualidade (CQ) em RM. No Brasil, há poucos trabalhos publicados discutindo os procedimentos para o CQ em RM e não existem normas nacionais para sua regulamentação. A normatização e recomendação sobre CQ em equipamentos de RM se restringe a trabalhos de organizações internacionais. Os objetos de teste comercialmente disponíveis mais conhecidos são o objeto de teste (OT) Eurospin e o American College of Radiology (ACR), sendo que diversos grupos de pesquisa internacionais têm publicado trabalhos sobre o CQ em RM com resultados promissores utilizando esses objetos. O objetivo desse trabalho é estudar a metodologia de utilização dos objetos de teste Eurospin e ACR, comparando as diferenças de execução dos testes, resultando em um material de orientação para utilização destes objetos de teste na rotina de CQ em RM. Os parâmetros de qualidade – razão sinal ruído (RSR), uniformidade, distorção geométrica, espessura de corte, posição de corte, resolução espacial de alto contraste, porcentagem do sinal fantasma e detecção de baixo contraste – foram avaliados e executados em dois equipamentos de RM de 1,5 T com os objetos de teste ACR e Eurospin. Os dois equipamentos de RM utilizados apresentaram resultados de todos os testes dentro dos critérios de aceitação. Os objetivos desse trabalho foram alcançados, visto que foi possível estudar a metodologia de utilização dos objetos de teste Eurospine ACR e comparar as formas de execução, tendo sido elaborado um protocolo operacional para realização do CQ em RM.Magnetic resonance imaging (MRI) is a method of diagnostic imaging which has advantages over other methods, which caused the number of installed equipment in the large Brazilian centers increased 88% over the past 5 years and about 508% in the last 15 years, which shows the importance of this method as a diagnostic imaging modality. To ensure medical imaging with diagnostic quality, it is necessary that the equipment is monitored for quality of the images they produce. Therefore, in order to maintain the quality of medical images at the highest level and ensure the proper performance of equipment, are implemented Quality Control (QC) programs in MRI. In Brazil, there are few works published discussing the procedures for the QC in MRI and there are no national standards for its regulation. The standardization and recommendation on QC in MRI is restricted to the work of international organizations. The best-known commercially available test objects are the test object (TO) Eurospin and the American College of Radiology (ACR), and several international research groups have published studies on QC in MRI with promising results using these objects. The aim of this work is to study the methodology of use of the test objects Eurospin and ACR, comparing the differences in test implementation, resulting in a guidance material for use of the test objects in the QC routine in MRI. The quality parameters – signal noise ratio (SNR), uniformity, geometric distortion, slice thickness, slice position, high-contrast spatial resolution, percentage of ghost signal and low contrast detection – were evaluated and performed in two MRI equipment of 1.5 T with the test objects ACR and Eurospin. The two MRI systems showed results of all tests within the acceptance criteria. The objectives of this study were achieved, since it was possible to study the methodology of using Eurospin and ACR test objects and compare the performance, and an operational protocol guide for performing the QC in MRI was developed.
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Moraes, Fábio Brignol de. "Avaliação das emissões conduzidas e radiadas geradas por unidade eletrocirúrgica e sistema de iluminação com lâmpadas fluorescentes em equipamentos médicos." Universidade Tecnológica Federal do Paraná, 2013. http://repositorio.utfpr.edu.br/jspui/handle/1/797.
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Este trabalho apresenta um estudo sobre interferência eletromagnética, emissões radiada e conduzida, gerados pelo sistema de iluminação e pela unidade de eletrocirurgia (bisturi eletrônico) numa sala cirúrgica de um hospital da cidade de Pato Branco/PR. O trabalho consistiu em medidas de emissões conduzidas e radiadas de sistemas de iluminação fluorescentes em laboratório e de emissões conduzidas e radiadas “in loco” da unidade de eletrocirurgia. Além disso, foi feito estudo de referenciais sobre as normas, nacionais e internacionais, que incidem sobre estes dois sistemas. Como resultado do trabalho tem-se um panorama sobre a situação das emissões conduzidas e radiadas, pelos sistemas de iluminação fluorescente e unidade eletrocirúrgica utilizados no hospital.This work presents a study on electromagnetic interference radiated and conducted emissions generated by the lighting system and the electrosurgery unit (eletric scalpel) in na operating room of a hospital in Pato Branco / PR. The work consisted of measurements of conducted and radiated emission of fluorescent lighting systems in the laboratory of conducted and radiated “in loco” electrosurgery unit emissions. Futhermore, a study was made of references on standarts, national and international, that focus on these two systems. Because of the work, has an overview on the situation of conducted and radiated emissions, the fluorecent lighting used in electrosurgical unit and hospital systems.
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Sutcliffe, Laura Francesca Rose. "Environmentally conscious design of medical devices." Thesis, University of Cambridge, 2012. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.610758.
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Johnson, Jonathan. "Managing technology feasibility within the medical device industry." Thesis, University of Cambridge, 2013. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.648198.
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Murphy, Robert S. "The design of safety-critical medical infusion devices." Thesis, University of South Wales, 2007. https://pure.southwales.ac.uk/en/studentthesis/the-design-of-safetycritical-medical-infusion-devices(1557c702-3087-43f9-a399-99a9ba65ae9b).html.
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Intravenous infusion devices - commonly known as infusion pumps - provide clinicians with mechanisms to automate the accurate dosing of potent fluid therapies to critically ill patients. In critical care applications, fluid dosing must be both accurate and safe since unwanted flow disturbance can cause physiological harm to the patient. This study consists of three discrete projects based on these vital themes of safe device design and accurate fluid delivery. The first project, commissioned by Medical Magnetics Ltd during the period 1998 onwards, proposed that the fail-safe design philosophy universally used in the design of infusion pumps, and implemented in embedded software, is lengthy and provides the manufacturer with difficulties in demonstrating the exhaustive fail-safe validation needed for an instrument to be released speedily for sale. An alternative and innovative strategy employing the design of hardware modules and using re-configurable VLSI, is proposed and shown to offer a significant reduction of the design and validation phase of development with consequent financial benefit to the manufacturer. The second project conducted as part of the Manukau Institute Research Programme for 2003 examined the manner in which dosing accuracy is assessed for infusion pumps. The International Standard used by clinicians to select apparatus suitable for treatment of 'critically-ill' patients is shown to be flawed and potentially misleading - a finding of international significance. An innovative mathematical simulation model is described that enables prediction of flow accuracy for various expected operating scenarios previously impossible to investigate using current laboratory measurement techniques. Use of this simulation model indicates that various mechanical design factors influencing system compliance and hence dosing accuracy have been previously ignored by designers and suggests that contemporary infusion pump designs are far from optimum. These findings offer an explanation for instances of dosing error previously reported in the clinical literature and are of international value. The third project of the study utilises the findings of, and is subsequent to, the second project. An innovative design is proposed for an infusion therapy device in which dosing accuracy may be maintained under operating conditions such as height change and patient venous pressure variation that cause unwanted errors in conventional equipment designs. This design is the subject of patent application, commercial exploitation and further development.
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Seagrave, Susanne M. "The role of expensive technologies in the new medical marketplace /." Diss., Connect to a 24 p. preview or request complete full text in PDF format. Access restricted to UC campuses, 1998. http://wwwlib.umi.com/cr/ucsd/fullcit?p9906474.
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Çetin, Aslı Seçkin Yavuz. "Applying product design methods to medical device design with a case study on home care devices/." [s.l.]: [s.n.], 2004. http://library.iyte.edu.tr/tezler/master/endustriurunleritasarimi/T000449.pdf.
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Slevar, Amy E. "Mechanical fatigue in a magnetically levitated axial blood pump /." Online version of thesis, 2007. http://hdl.handle.net/1850/4893.
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Amaral, Pedro Vasconcelos Maia Do. "Spatial structure of health equipment in Brazil." Thesis, University of Cambridge, 2013. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.608168.
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Ronne, Luke John Thomas. "Design considerations and analysis of a bioreactor for application in a bio-artificial liver support system." Pretoria : [s.n.], 2006. http://upetd.up.ac.za/thesis/available/etd-04242008-093504/.
Full textBooks on the topic "Medical instruments and apparatus Standards"
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Law Library of Congress (U.S.). Global Legal Research Directorate. Approval of medical devices. [Washington, D.C.]: Law Library of Congress, Global Legal Research Center, 2014.
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Dills, David. Technical guide: Conducting effective medical device validations. Royal Palm Beach, FL: Institute of Validation Technology, 1999.
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Dills, David. Technical guide: Conducting effective medical device validations. Royal Palm Beach, FL: Institute of Validation Technology, 1999.
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Association for the Advancement of Medical Instrumentation. Essential standards for biomedical equipment safety and performance. Arlington, Va: Association for the Advancement of Medical Instrumentation, 1985.
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IEE Seminar on Medical Device Standards & Regulations -- All Change (2005 London, England). The IEE Seminar on Medical Device Standards & Regulations -- All Change: 9 March 2005. London: IEE, 2005.
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Boozang, Kathleen M., and Simone Handler-Hutchinson. Pharmaceutical and medical device compliance manual. Washington, DC: American Health Lawyers Association, 2012.
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Steinborn, Leonard. GMP/ISO Quality Audit Manual for Healthcare Manufacturers: Regulations, Standards, and Guidelines. 6th ed. Hoboken: Informa Healthcare, 2004.
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Judy, Strojny, Puleo Joseph, and Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance, eds. Medical device quality systems manual: A small entity compliance guide. Rockville, Md: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 1996.
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Lowery, Andrew. Medical device quality systems manual: A small entity compliance guide. Rockville, Md: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 1996.
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Device Submissions Workshop (4th 1994 Arlington, Va.). Straight talk from the FDA about submissions: Remarks of ODE Division Directors at the 1994 HIMA Device Submissions Workshop, July 18, 1994, Arlington, Virginia. Washington, D.C. (1200 G St., N.W., Suite 400, Washington 20005-3814): Health Industry Manufacturers Association, 1994.
Find full textBook chapters on the topic "Medical instruments and apparatus Standards"
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Huang, Jieqiong. "Design Research on Self-service Medical Apparatus and Instruments Aiming at Elderly Users." In Human Aspects of IT for the Aged Population. Healthy and Active Aging, 3–15. Cham: Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-39949-2_1.
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Büthe, Tim, and Walter Mattli. "The Politics of Nuts and Bolts—and Nanotechnology." In The New Global Rulers. Princeton University Press, 2011. http://dx.doi.org/10.23943/princeton/9780691144795.003.0007.
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This chapter examines how companies affected by international product standards assess these standards and the extent to which they are able to influence rule-making in the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Drawing on the results of a business survey among standards experts in firms in the United States and four European countries (Germany, Spain, Sweden, and the United Kingdom), the chapter considers the importance of institutional complementarity in international standard-setting across five industries: chemicals; rubber and plastic products; medical instruments and medical devices; petroleum products; and iron and steel products. It shows that high complementarity between standard-setting institutions at the domestic level and the institutional structure of standardization at the international level favors European over American interests in ISO and IEC. By contrast, the relatively poor fit between U.S. domestic institutions and the international structure puts U.S. firms at a disadvantage.
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Burgers, Darcy E., Sarah J. Tarquini, Anne E. Kazak, and Anna C. Muriel. "Screening and Assessment in Pediatric Psycho-Oncology." In Psycho-Oncology, edited by William S. Breitbart, 687–95. Oxford University Press, 2021. http://dx.doi.org/10.1093/med/9780190097653.003.0086.
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This chapter provides an overview of current and recommended practices regarding systematic screening and assessment of psychosocial needs in pediatric oncology. The chapter reviews published recommendations from the Psychosocial Standards of Care Project for Childhood Cancer and provides information about validated instruments for brief screening of children and their families. It also describes guidelines for using follow-up symptom-based measures and in-person clinical assessment. It includes a summary of what is known about the current implementation of screening nationally, and possible steps to enhance implementation. There is also special consideration of screening and assessment of unique medical populations within pediatric oncology, children with developmental concerns, and families from different cultures. Future directions include using implementation science to develop models for routine screening and demonstrating the impact of screening on psychosocial outcomes for patients and families and on the system of pediatric oncology care.
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Dulhare, Uma N., and Shaik Rasool. "Digital Evidence in Practice." In Advances in Digital Crime, Forensics, and Cyber Terrorism, 119–39. IGI Global, 2016. http://dx.doi.org/10.4018/978-1-5225-0193-0.ch008.
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Advanced Evidence is any data of probative quality that is either put away or transmitted in a double frame. In today's universe of propelling advances, more data is being produced, put away and appropriated by electronic means. This requires numerous offices to build the utilization of advanced proof social affair as a regular or standard instrument in their fight against violations. Computerized proof can be helpful in an extensive variety of criminal examinations. Numerous computerized gadgets productively track client action; it is likewise conceivable to recoup erased records, both of which may influence a criminal examination. Data is similar to the backbone for associations of all sizes, sorts and industry areas. It should be overseen and secured, and when there is a break or wrongdoing conferred including spilled or stolen data, the culprits must be recognized and indicted. Expanded Internet entrance has given exponential ascent in refined assaults on Information Technology framework. Keeping in mind the end goal to make our IT framework versatile against the dangers, there is a requirement for Cyber Security. Digital criminology, likewise called PC legal sciences or advanced legal sciences, is the procedure of extricating data and information from PCs to serve as computerized proof - for common purposes or, by and large, to demonstrate and lawfully indict cybercrime. PC crime scene investigation has as of late increased noteworthy Popularity with numerous nearby law authorization organizations. It is at present utilized in extortion, robbery, drug authorization and each other implementation action. Law implementation organizations confront another test in managing digital wrongdoings. Criminal acts are being perpetrated and the confirmation of these exercises is recorded in electronic structure. Also, wrongdoings are being dedicated in the internet. Proof in these violations is quite often recorded in computerized design. It is critical that PC security experts know about a percentage of the necessities of the lawful framework and comprehends the creating field of PC legal sciences. It will clarify why Digital Evidence is a vital part of any crime scene investigation examination and why strict approaches and methodology must exist to manage the administration of confirmation. Digital examination conventions offer specialists some assistance with gathering computerized proof in a forensically substantial manner. Computerized proof is “information that is made, controlled, put away or conveyed by any gadget, PC or PC framework or transmitted over a correspondence framework that is significant to the procedure.” The section will give a brief of how Digital confirmation starts from a large number of sources including seized PC hard-drives and reinforcement media, ongoing email messages, talk room logs, ISP records, site pages, advanced system activity, nearby and virtual databases, computerized catalogs, remote gadgets, memory cards, and computerized cameras. The advanced confirmation is not virtual exist, but rather there are some different components to search for, the computerized proof can be duplicated with boundless contrasts, can be altered effortlessly, difficult to be distinguished the first asset, can be incorporated information check, and can't be seen straightforwardly without specialized procedure. The trust value of this computerized information is a basic question that advanced scientific analysts must consider. For this reason, part “advanced proof” partitioned into seven classifications. This part gives the learning important to handle advanced confirmation in its numerous structures, to utilize this proof to construct a case, to manage the difficulties connected with this kind of confirmation and ways to deal with taking care of computerized proof put away and transmitted utilizing systems as a part of a way that is well on the way to be acknowledged by law. The section presents the procedure of distinguishing, saving, examining and displaying computerized proof in a way that is legitimately satisfactory. It will clarify why Digital Evidence is an imperative part of any crime scene investigation examination and why strict arrangements and techniques must exist to manage the administration of proof. The section will give a brief of how Digital confirmation starts from a huge number of sources including seized PC hard-drives. Further the part will contain order of computerized confirmations where Digital proof can be grouped, looked at, and individualized in a few ways. One of those courses is by the substance of the confirmation. The later Section in the part will contain how the advanced proofs are gathered, what techniques and apparatuses can be utilized to safeguard the computerized confirmations.
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Dulhare, Uma N., and Shaik Rasool. "Digital Evidence in Practice." In Cyber Warfare and Terrorism, 1–22. IGI Global, 2020. http://dx.doi.org/10.4018/978-1-7998-2466-4.ch001.
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Advanced Evidence is any data of probative quality that is either put away or transmitted in a double frame. In today's universe of propelling advances, more data is being produced, put away and appropriated by electronic means. This requires numerous offices to build the utilization of advanced proof social affair as a regular or standard instrument in their fight against violations. Computerized proof can be helpful in an extensive variety of criminal examinations. Numerous computerized gadgets productively track client action; it is likewise conceivable to recoup erased records, both of which may influence a criminal examination. Data is similar to the backbone for associations of all sizes, sorts and industry areas. It should be overseen and secured, and when there is a break or wrongdoing conferred including spilled or stolen data, the culprits must be recognized and indicted. Expanded Internet entrance has given exponential ascent in refined assaults on Information Technology framework. Keeping in mind the end goal to make our IT framework versatile against the dangers, there is a requirement for Cyber Security. Digital criminology, likewise called PC legal sciences or advanced legal sciences, is the procedure of extricating data and information from PCs to serve as computerized proof - for common purposes or, by and large, to demonstrate and lawfully indict cybercrime. PC crime scene investigation has as of late increased noteworthy Popularity with numerous nearby law authorization organizations. It is at present utilized in extortion, robbery, drug authorization and each other implementation action. Law implementation organizations confront another test in managing digital wrongdoings. Criminal acts are being perpetrated and the confirmation of these exercises is recorded in electronic structure. Also, wrongdoings are being dedicated in the internet. Proof in these violations is quite often recorded in computerized design. It is critical that PC security experts know about a percentage of the necessities of the lawful framework and comprehends the creating field of PC legal sciences. It will clarify why Digital Evidence is a vital part of any crime scene investigation examination and why strict approaches and methodology must exist to manage the administration of confirmation. Digital examination conventions offer specialists some assistance with gathering computerized proof in a forensically substantial manner. Computerized proof is “information that is made, controlled, put away or conveyed by any gadget, PC or PC framework or transmitted over a correspondence framework that is significant to the procedure.” The section will give a brief of how Digital confirmation starts from a large number of sources including seized PC hard-drives and reinforcement media, ongoing email messages, talk room logs, ISP records, site pages, advanced system activity, nearby and virtual databases, computerized catalogs, remote gadgets, memory cards, and computerized cameras. The advanced confirmation is not virtual exist, but rather there are some different components to search for, the computerized proof can be duplicated with boundless contrasts, can be altered effortlessly, difficult to be distinguished the first asset, can be incorporated information check, and can't be seen straightforwardly without specialized procedure. The trust value of this computerized information is a basic question that advanced scientific analysts must consider. For this reason, part “advanced proof” partitioned into seven classifications. This part gives the learning important to handle advanced confirmation in its numerous structures, to utilize this proof to construct a case, to manage the difficulties connected with this kind of confirmation and ways to deal with taking care of computerized proof put away and transmitted utilizing systems as a part of a way that is well on the way to be acknowledged by law. The section presents the procedure of distinguishing, saving, examining and displaying computerized proof in a way that is legitimately satisfactory. It will clarify why Digital Evidence is an imperative part of any crime scene investigation examination and why strict arrangements and techniques must exist to manage the administration of proof. The section will give a brief of how Digital confirmation starts from a huge number of sources including seized PC hard-drives. Further the part will contain order of computerized confirmations where Digital proof can be grouped, looked at, and individualized in a few ways. One of those courses is by the substance of the confirmation. The later Section in the part will contain how the advanced proofs are gathered, what techniques and apparatuses can be utilized to safeguard the computerized confirmations.
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Dulhare, Uma N., and Shaik Rasool. "Digital Evidence in Practice." In Digital Forensics and Forensic Investigations, 259–80. IGI Global, 2020. http://dx.doi.org/10.4018/978-1-7998-3025-2.ch018.
Full textAbstract:
Advanced Evidence is any data of probative quality that is either put away or transmitted in a double frame. In today's universe of propelling advances, more data is being produced, put away and appropriated by electronic means. This requires numerous offices to build the utilization of advanced proof social affair as a regular or standard instrument in their fight against violations. Computerized proof can be helpful in an extensive variety of criminal examinations. Numerous computerized gadgets productively track client action; it is likewise conceivable to recoup erased records, both of which may influence a criminal examination. Data is similar to the backbone for associations of all sizes, sorts and industry areas. It should be overseen and secured, and when there is a break or wrongdoing conferred including spilled or stolen data, the culprits must be recognized and indicted. Expanded Internet entrance has given exponential ascent in refined assaults on Information Technology framework. Keeping in mind the end goal to make our IT framework versatile against the dangers, there is a requirement for Cyber Security. Digital criminology, likewise called PC legal sciences or advanced legal sciences, is the procedure of extricating data and information from PCs to serve as computerized proof - for common purposes or, by and large, to demonstrate and lawfully indict cybercrime. PC crime scene investigation has as of late increased noteworthy Popularity with numerous nearby law authorization organizations. It is at present utilized in extortion, robbery, drug authorization and each other implementation action. Law implementation organizations confront another test in managing digital wrongdoings. Criminal acts are being perpetrated and the confirmation of these exercises is recorded in electronic structure. Also, wrongdoings are being dedicated in the internet. Proof in these violations is quite often recorded in computerized design. It is critical that PC security experts know about a percentage of the necessities of the lawful framework and comprehends the creating field of PC legal sciences. It will clarify why Digital Evidence is a vital part of any crime scene investigation examination and why strict approaches and methodology must exist to manage the administration of confirmation. Digital examination conventions offer specialists some assistance with gathering computerized proof in a forensically substantial manner. Computerized proof is “information that is made, controlled, put away or conveyed by any gadget, PC or PC framework or transmitted over a correspondence framework that is significant to the procedure.” The section will give a brief of how Digital confirmation starts from a large number of sources including seized PC hard-drives and reinforcement media, ongoing email messages, talk room logs, ISP records, site pages, advanced system activity, nearby and virtual databases, computerized catalogs, remote gadgets, memory cards, and computerized cameras. The advanced confirmation is not virtual exist, but rather there are some different components to search for, the computerized proof can be duplicated with boundless contrasts, can be altered effortlessly, difficult to be distinguished the first asset, can be incorporated information check, and can't be seen straightforwardly without specialized procedure. The trust value of this computerized information is a basic question that advanced scientific analysts must consider. For this reason, part “advanced proof” partitioned into seven classifications. This part gives the learning important to handle advanced confirmation in its numerous structures, to utilize this proof to construct a case, to manage the difficulties connected with this kind of confirmation and ways to deal with taking care of computerized proof put away and transmitted utilizing systems as a part of a way that is well on the way to be acknowledged by law. The section presents the procedure of distinguishing, saving, examining and displaying computerized proof in a way that is legitimately satisfactory. It will clarify why Digital Evidence is an imperative part of any crime scene investigation examination and why strict arrangements and techniques must exist to manage the administration of proof. The section will give a brief of how Digital confirmation starts from a huge number of sources including seized PC hard-drives. Further the part will contain order of computerized confirmations where Digital proof can be grouped, looked at, and individualized in a few ways. One of those courses is by the substance of the confirmation. The later Section in the part will contain how the advanced proofs are gathered, what techniques and apparatuses can be utilized to safeguard the computerized confirmations.
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Schultz, Robert A. "Professional Duties." In Contemporary Issues in Ethics and Information Technology, 44–59. IGI Global, 2006. http://dx.doi.org/10.4018/978-1-59140-779-9.ch004.
Full textAbstract:
It is perhaps easiest to begin the application of ethics to information technology with the ethical responsibilities of IT professionals. Several ethical codes have been developed, and in this chapter we will see how the concepts of Part I apply to these codes. My aim is to establish the ethical basis of these codes. The underlying ethical concepts are Rawlsian, but not his Principles of Justice (Rawls, 1999). Rather, they are distinctions developed as part of the theory of right action. The distinction between duty and obligation is particularly relevant. In addition, something needs to be said about the concept of a profession. Most IT professionals have a very strong sense of their responsibilities as IT professionals. In a way, it is astonishing that such a young profession has developed such a strong sense of its own ethical identity so quickly. Older professions such as Medicine or Law have traditions going back over two thousand years, and their standards have been incorporated into law in most areas. Although IT has its professional organizations, such as the Association for Computing Machinery (ACM) and the Association of Information Technology Professionals (AITP), those organizations do not currently perform a widely recognized credentialing function. Although these organizations promulgate model curricula, they have nothing like the force of the American Medical Association (AMA) certification for medical schools, or the American Bar Association (ABA) certification of law schools. Since IT is a profession without benefit of the formal apparatus of the older professions, it follows that the credentialing and legal sanctions of the older professions are not what makes them professions. Credentialing and legal sanctions safeguard what was already there, namely a calling shared by individuals. Professions differ from mere jobs because those in professions commit themselves indefinitely toward serving a goal beyond their own self-interest, which is their primary focus. Thus, those in the medical profession commit themselves to healing people, and those in the law commit themselves to interpreting and applying the law and preserving the integrity of the legal process. Professional athletes similarly commit themselves to practicing their sport as well as they can. All professionals are prepared to set aside their individual interests when their profession requires it. The basis of a profession—an individually adopted goal beyond self-interest—is also the essential basis for professional ethics.1 What then is this goal for IT professionals? What do IT professionals feel called to do? I think their calling is to provide the best functioning IT systems (infrastructure and applications) possible in the organizational context in which they are dealing. In terms of this calling, IT professionals know what they need to take responsibility for in the technical area, even when managers or clients have other ideas. These responsibilities are often not mandated by management. Indeed, management may not even be aware that IT professionals have assumed and carried out these responsibilities. Yet the well-being of the organization may very well depend on these responsibilities being carried out. A good example is data integrity; nonprofessionals usually have only a vague idea of what is involved in insuring data integrity, and yet failures in insuring data integrity will almost certainly compromise the usability of a system. Even without formal, generally accepted credentialing for IT professionals, there is still a distinct calling recognized by IT professionals with duties attached to it. The absence of generally accepted credentialing does, however, create possibilities for conflicts with management and others, which we will discuss later in this chapter.
Conference papers on the topic "Medical instruments and apparatus Standards"
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Azzi, M., E. Bitar-Nehme, and J. E. Klemberg-Sapieha. "Design of New Multifunctional Galling-Corrosion Testing Apparatus." In ASME 2014 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2014. http://dx.doi.org/10.1115/imece2014-39404.
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Galling of materials is a severe surface damage characterized by macroscopic material removal when two solid surfaces experience relative sliding under high load. This mode of wear is of particular interest in applications where design constraints require assembly components to slide against each other without adequate lubrication. Examples are high-pressure ball valve with metal-to-metal seal contact, sheet metal forming process and medical/food processing instruments where lubrication is sometimes non-existent due contamination concerns. In addition to sliding at high load, materials in these applications can be exposed to aggressive environments which lead to combined tribological and corrosive degradation phenomena. Progress in this field depends largely on the understanding of the interaction between corrosion and wear processes. In this paper, we describe a new testing instrument capable of testing galling and sliding wear behavior under dry and wet conditions. Design of this instrument is guided by ASTM standards G98 for galling, G99 for pin-on-disk, G133 for ball-on-flat and G199 for tribocorrosion. Galling configuration consists of two concentrically aligned hollow cylindrical specimen loaded along their longitudinal axis with constant load (max 5000 N). The upper specimen is held stationary while the lower specimen is rotated a number of cycles at a selected speed. During the test, the friction torque is measured using special torque/thrust load cell. For the combined galling/corrosion test, the specimen’s contact surface is submerged in an electrolytic solution and three-electrode type electrochemical cell is set-up using the specimens as working electrode. Galling/corrosion tests can be performed under open circuit potential or under controlled potentials. In the first type, the corrosion potential is monitored before, during and after rubbing, whereas in the second type, the corrosion potential and corrosion current are controlled before, during and after rubbing. In addition to galling, the instrument can also be used to conduct pin-on-disk and ball-on-flat tests under dry and wet conditions.
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Cheng, Luyao. "A Listed Company Evaluation Based on DCF Model-the Case of Medical Apparatus and Instruments Industry." In 2021 3rd International Conference on Economic Management and Cultural Industry (ICEMCI 2021). Paris, France: Atlantis Press, 2021. http://dx.doi.org/10.2991/assehr.k.211209.137.
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Reese, Paul. "Calibration in Regulated Industries: Federal Agency Use of ANSI Z540.3 and ISO 17025." In NCSL International Workshop & Symposium. NCSL International, 2016. http://dx.doi.org/10.51843/wsproceedings.2016.21.
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ANSI/NCSL Z540.3-2006 and ISO/IEC 17025:2005 are voluntary consensus standards which prescribe requirements for the calibration of measuring and test equipment and for the technical competency of the performing laboratories. Many agencies in the U.S. which are part of, or regulated by, the Federal Government are required to use instruments which have been calibrated in accordance with one or both of these standards. The National Technology Transfer and Advancement Act (NTTAA) of 1995 compels all federal agencies to use technical standards that are developed by consensus standards bodies, in lieu of "government-unique" standards. ISO 17025 and ANSI Z540.3 have evolved over a half-century of metrological advancement, drawing upon expertise in the public and private sector. They are now supported by a mature infrastructure that facilitates mutual recognition and global trade, ensuring calibrations are accepted worldwide. However, some federal agencies and regulatory bodies in the U.S. have not yet adopted these standards. Calibrations are routinely performed on instruments, utilized in some government-regulated industries, which may not conform to these requirements. This paper discusses risks imparted to products and services produced in such environments. Particular focus is given to the Food and Drug Administration's (FDA) regulation of calibration requirements in the Quality System Regulation (QSR) found in Title 21 of the Code of Federal Regulations (CFR). Currently, a paucity of official guidance exists with respect to what constitutes an acceptable calibration program in medical device and pharmaceutical industries. Ambiguities persist due to lack of agreement upon voluntary consensus standards such as ISO 17025 and ANSI Z540.3. Fundamental requirements such as traceability, measurement uncertainty, measurement decision-rules, as well as basic metrological definitions are ill-defined in the CFR. The objective of this paper is to provide relevant background information and to encourage constructive dialogue between government agencies, standards writing committees, industry partners, and third party assessment/accreditation bodies. Cooperation of this type is consistent with public law and White House policy objectives. Ultimately, such dialogue may foster agreement on the use of these voluntary consensus standards for calibration in regulated industries, resulting in improved quality and reduced risk to consumers and patients.
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Williams, Adam, Wael Saab, and Pinhas Ben-Tzvi. "Analysis of Differential Mechanisms for a Robotic Head Stabilization System." In ASME 2017 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference. American Society of Mechanical Engineers, 2017. http://dx.doi.org/10.1115/detc2017-67371.
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This paper presents a robotic system intended to help automate the head and neck stabilization process performed on trauma patients through application of a differential apparatus, a device that distributes an input between multiple output channels. A system to streamline the head stabilization process can save valuable time in a life and death scenario, as well as play a key role in future work on a mobile stretcher robot. This investigation focuses on finding the most suitable device to accommodate multiple possible head positions while maintaining a steady force in order to provide secure motion restriction. After an initial review of current emergency medical services standards, a comparison of potential differential mechanisms is undertaken. Static analysis as well as dynamic modeling is performed in order to determine the most appropriate mechanisms. An initial prototype design incorporating a differential pulley, the most mechanically advantageous mechanism, is then introduced.
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Yang, Steven. "Calibration of Elctrocardiograph (ECG) Simulators." In NCSL International Workshop & Symposium. NCSL International, 2016. http://dx.doi.org/10.51843/wsproceedings.2016.36.
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The Standards and Calibration Laboratory (SCL) in Hong Kong has set up a calibration facility for electro-cardio graph (ECG) simulators. ECGs are medical devices designed to measure the electrical signals associated with cardiac activity. They are used to diagnose heart diseases and arrhythmias, which are commonly used in hospitals, emergency facilities and medical institutes. Routine performance check of ECGs could be performed by ECG simulator. In order to ensure the accuracy of the instruments, calibration procedures which are traceable to primary standards or SI units are essential. At the SCL, the output signal from an ECG simulator is measured by a differential amplifier and a high speed digital sampling system. The system also includes a reference voltage source, an inductive voltage divider and a control computer. Digital sampling system enables the calibration of non-sinusoidal wave with high accuracy. Signal characteristics including signal amplitude, frequency and wave form could be evaluated by an in-house developed program for normal sinus rhythm waveforms as well as for ECG performance waveforms (sinusoidal, triangle, square and pulse). Since the test signal is in the sub-millivolt (mV) range, a differential amplifier with high common mode rejection ratio is used to amplify the test signal. The frequency response of the differential amplifier is calibrated by a reference voltage source and an inductive voltage divider, whereas the digital sampling system is calibrated against the laboratory's voltage and frequency reference standards. The developed calibration system is capable of measuring signals in the sub-mV level with test uncertainty ratio (TUR) better than 4. Details of the system configurations and the uncertainty evaluation will be described in the paper.
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Mohamed Mohamed, Ashraf Elsayed. "The International Safety Regime of Radioactive Materials Transport." In 18th International Conference on Nuclear Engineering. ASMEDC, 2010. http://dx.doi.org/10.1115/icone18-30334.
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Every day thousands of shipments of radioactive materials are transported on international and national routes. These consignments, which are carried by road, rail, sea, air and inland waterway, can range from smoke detectors and cobalt sources for medical uses to reprocessed fuel for use in electricity generation. The transport of radioactive materials worldwide is governed by stringent regulatory regime, which includes standards, codes and regulations that have been continuously revised and updated over the past four decades. The safety measures have been developed to protect the general public, transport workers, emergency response teams and the environment against the risks posed by the cargoes. These risks include the radioactivity itself and other chemical risks that the cargoes may pose, such as toxicity or corrosivity. In addition to the safety regulations, the regulatory regime addresses other, related issues such as physical protection and liability. It was recognized that these standards should provide a uniform, global regime to ensure that all parties apply the same provisions. Since 1961, the UN (United Nations) has published and periodically reviewed and updated the regulations for the safe transport of radioactive material. These regulations are used today by more than 60 countries as the basic for their national regulations. In addition, the main international modal organizations responsible for the safe transport of dangerous goods by road, rail, sea, air and inland waterways have incorporated the relevant parts of the UN regulations into their own instruments. This paper will discuss and outline the principal regulations that apply to the transport of radioactive materials such as the UN regulations for the safe transport of radioactive materials, The UN regime governing the international transport of dangerous goods, the principal modal regulations governing the transport of dangerous goods and achievement of a more harmonized regime. and the international organizations responsible for their development and implementation.
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Gillard, Joel, and Terry Smith. "A Model for Sustainable Orthopedic Care in Low and Middle Income Countries." In ASME 2020 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2020. http://dx.doi.org/10.1115/imece2020-23332.
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Abstract This paper describes a scalable and sustainable patient care model for low and middle-income countries (LMICs) that can improve the standard of care for hospitals with scarce resources and an ever growing backlog of patients. SIGN Fracture Care International (SIGN), a non-profit, humanitarian medical device organization, has developed technical solutions over the last 20 years, to address the yearly increasing number of patients affected by upper and lower extremity trauma, using a three-pronged approach. The model includes effective training of in-country local surgeons on current orthopaedic techniques; providing an on-going supply of appropriately designed surgical implants and instruments manufactured to ISO 13485 and FDA standards; and evaluating patient outcomes until healing occurs to validate the model is truly benefiting patients and the hospital throughput. By providing equal access to technology, knowledge, and timely feedback, LMIC surgeons can provide vital orthopedic care to their local communities and sustainably respond to the daily trauma cases they encounter and enable patients to return to work, school, keep families on the path out of poverty, and improve the lives of future generations. The model is describe in detail in the hopes that other entities can utilize the principles for additional healthcare specialties around the world.