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2015 IEEE Symposium on Product Compliance Engineering (ISPCE)

18-20 May 2015

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Displaying Results 1 - 18 of 18
  • [Front cover]

    Publication Year: 2015, Page(s): 1
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  • [Copyright notice]

    Publication Year: 2015, Page(s): ii
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  • Table of contents

    Publication Year: 2015, Page(s):iii - viii
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  • Welcome message

    Publication Year: 2015, Page(s):ix - xv
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  • The pre-mortem: An alternative method of predicting failure

    Publication Year: 2015, Page(s):1 - 4
    Request permission for commercial reuse | Click to expandAbstract | PDF file iconPDF (1262 KB) | HTML iconHTML

    Most people are familiar with the idea of a postmortem. When referring to product development, the postmortem is a review performed after a failure has occurred. The intention is to look at the failure in detail to figure out the root cause. However, you need not wait until a failure occurs. One management technique with growing popularity is the pre-mortem. The pre-mortem is performed early in th... View full abstract»

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  • Dielectric strength testing: Transient over-voltage withstand testing

    Publication Year: 2015, Page(s):1 - 6
    Request permission for commercial reuse | Click to expandAbstract | PDF file iconPDF (1226 KB) | HTML iconHTML

    Contrary to what is published elsewhere, electric strength testing is not a margin above the voltage to which the insulation is subjected. Instead, the “hi-pot” test is to determine that the safeguard insulations will withstand the normally-occurring transient over-voltages. This paper discusses why electric strength greater than normal voltage is necessary, and the process of electr... View full abstract»

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  • Introduction to IEC 60335 — Household and similar electrical appliances — Safety

    Publication Year: 2015, Page(s):1 - 6
    Request permission for commercial reuse | Click to expandAbstract | PDF file iconPDF (1182 KB) | HTML iconHTML

    We and our families are in contact with household appliances on a daily basis. Their safety is enhanced by complying with standards such as the IEC 60335 series. It is important for product compliance and design engineers to be familiar with the requirements of safety standards for household appliances during the design and production of these products. View full abstract»

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  • Levels of conceptual interoperability model for healthcare framework for safe medical device interoperability

    Publication Year: 2015, Page(s):1 - 8
    Cited by:  Papers (3)
    Request permission for commercial reuse | Click to expandAbstract | PDF file iconPDF (2803 KB) | HTML iconHTML

    The Medical Device and Healthcare Information Technology (HIT) industries have not achieved safe PNP cross-manufacturer (heterogeneous) interoperability although it has been achieved decades ago in other safety critical industries. We believe that the Levels of Conceptual Interoperability Model (LCIM) [1] offers an essential account of the disparity and thereby offers insight for how to achieve sa... View full abstract»

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  • A new structure for the EU LVD directive: The European union new legislative framework and new low voltage directive

    Publication Year: 2015, Page(s):1 - 5
    Request permission for commercial reuse | Click to expandAbstract | PDF file iconPDF (738 KB) | HTML iconHTML

    Changes in the European Union legislative process over the past decade have resulted in common sets of definitions, requirements, roles and responsibilities that are finding their way into EU Directive updates. These changes have shaped the new EU Low Voltage Directive (LVD) 2014/35/EU, helping to ensure products within the scope of this directive are compliant prior to being placed into EU market... View full abstract»

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  • HBSE and insulation coordination

    Publication Year: 2015, Page(s):1 - 6
    Request permission for commercial reuse | Click to expandAbstract | PDF file iconPDF (1026 KB) | HTML iconHTML

    Transient overvoltages are normal. Insulation must withstand not only the functional voltage, but also the transient overvoltages. A scheme called “insulation coordination” has been instituted by the International Electrical Commission to promulgate and standardize on coordinating the transient overvoltage suppression with insulation electric strength. This paper addresses the insula... View full abstract»

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  • A cybersecurity risk analysis methodology for medical devices

    Publication Year: 2015, Page(s):1 - 6
    Request permission for commercial reuse | Click to expandAbstract | PDF file iconPDF (691 KB) | HTML iconHTML

    The U.S. Food and Drug Administration (FDA) has expressed an ongoing emphasis on cybersecurity considerations for medical devices. The FDA recently issued guidelines regarding cybersecurity management in premarket submissions. In this paper we present a brief overview of security frameworks, and develop a cybersecurity risk assessment methodology for medical devices. Our approach is essentially th... View full abstract»

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  • HBSE and interlock schemes: The interlock model and its parameters

    Publication Year: 2015, Page(s):1 - 4
    Request permission for commercial reuse | Click to expandAbstract | PDF file iconPDF (1341 KB) | HTML iconHTML

    Interlocks are complex safety devices. Models have not been used in specifying requirements for interlocks. This paper uses models to show that an interlock scheme has two actuators, two safeguards, and either three or two modes to control the interlocked space. Finally, this paper analyzes the separation of the hazardous electrical energy source and the interlocked space. View full abstract»

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  • Towards a logic-based extension of a relational software tool for coherent technical documentation of medical devices

    Publication Year: 2015, Page(s):1 - 6
    Cited by:  Papers (1)
    Request permission for commercial reuse | Click to expandAbstract | PDF file iconPDF (1511 KB) | HTML iconHTML

    This work presents a novel software tool intended to support compilation of coherent technical documentation. It is based on a relational database system serving as knowledge base incorporating information from the European Medical Device Directive and harmonized standards such as ISO 14971, ISO 980 or ISO 10993-x. In order to achieve increased consistency among sections of documentation for medic... View full abstract»

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  • A critical review on China toys safety standards: GB6675-2014

    Publication Year: 2015, Page(s):1 - 4
    Request permission for commercial reuse | Click to expandAbstract | PDF file iconPDF (1057 KB) | HTML iconHTML

    China is one of the developing countries with a remarkable economic growth. Its Gross domestic product (GDP) was US$9.24 trillion in 2013 [1]. Due to the huge market, many international toys manufacturers came to sell their products in China. The Standardization Administration of the People's Republic of China (SAC) has published the new China National Toy Safety Standard in May 2014. Although the... View full abstract»

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  • USB Port and power delivery: An overview of USB port interoperabiliy

    Publication Year: 2015, Page(s):1 - 5
    Request permission for commercial reuse | Click to expandAbstract | PDF file iconPDF (1170 KB) | HTML iconHTML

    This paper discusses the interoperability between the computer USB port and handheld devices including power banks, cell phones and tablets. According to USB power delivery standard, a USB2.0 port can supply a maximum current of 0.5A at 5V [1] and a USB3.0 port can supply a maximum current of 0.9A at 5V [2], but the test results indicate that some of the handheld devices can draw 2.5A or more curr... View full abstract»

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  • Product safety program planning — From prescriptive to hazard-based safety

    Publication Year: 2015, Page(s):1 - 6
    Request permission for commercial reuse | Click to expandAbstract | PDF file iconPDF (716 KB) | HTML iconHTML

    The goal of a product safety program is to eliminate mishaps. To accomplish this goal we must design to eliminate energy hazards or reduce the probability of uncontrolled energy release to zero. In reality, neither of these ideals can be realized. Therefore, it is incumbent on product safety engineering to identify the energy sources, determine the energy transfer mechanisms, and establish adequat... View full abstract»

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  • New approaches to safe ventilation of equipment containing lead acid and NiCd batteries

    Publication Year: 2015, Page(s):1 - 5
    Request permission for commercial reuse | Click to expandAbstract | PDF file iconPDF (766 KB) | HTML iconHTML

    Several safety standards for information and communication technology (ICT) equipment installed outdoors have recently been updated to better ensure that those equipment housing lead-acid or nickel-cadmium (NiCd) batteries are well ventilated and do not pose a risk of explosion of combustible gases. New procedures in IEC 62368-1, IEC 60950-22, Second Edition, and Telcordia Standard GR-487-CORE, Is... View full abstract»

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  • Author index

    Publication Year: 2015, Page(s): 76
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