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2016 IEEE Symposium on Product Compliance Engineering (ISPCE)最新文献

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Regulatory compliance mark: For Australia/New Zealand electrical and electronic equipment 法规符合性标志:适用于澳大利亚/新西兰的电气电子设备
Pub Date : 2016-05-16 DOI: 10.1109/ISPCE.2016.7492843
Paul W. Robinson
This paper is an overview of the Australia/New Zealand (ANZ) Regulatory Compliance Mark (RCM) for electrical and electronic products. It covers the Australian regulatory environment, the scope of the mark, its history, its applications and rules today, and issues around implementation. This paper will mainly focus on Australia's perspective, with a little discussion of New Zealand as necessary to show interrelationships.
本文概述了澳大利亚/新西兰(ANZ)电气和电子产品的法规遵从标志(RCM)。它涵盖了澳大利亚的监管环境,商标的范围,其历史,其应用和今天的规则,以及有关实施的问题。本文将主要集中在澳大利亚的观点,与新西兰的一些讨论,必要的显示相互关系。
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引用次数: 1
Quantified fault tree techniques for calculating hardware fault metrics according to ISO 26262 根据ISO 26262计算硬件故障度量的量化故障树技术
Pub Date : 2016-05-16 DOI: 10.1109/ISPCE.2016.7492848
Nabarun Das, W. Taylor
Since its introduction in 2011, the ISO 26262 standard has provided the state-of-the-art methodology for achieving functional safety of automotive electrical and electronic systems. Among other requirements, the standard requires estimation of quantified metrics such as the Probabilistic Metric for Hardware Failure (PMHF) using quantitative failure analysis techniques. While the standard provides some brief guidance, a complete methodology to calculate the PMHF in detail has not been well described in literature. This paper will draw out several key frameworks for successfully calculating the probabilistic metric for hardware failure using Fault Tree Analysis (FTA). At the top levels of the analysis, methods drawn from previous literature can be used to organize potential failures within a complex multifunctional system. At the lower levels of the FTA, the effects of all fault categories, including dual-point latent and detected faults, can be accounted for using appropriate diagnostic coverage and proof-test interval times. A simple example is developed throughout the paper to demonstrate the methods. Some simplifications are proposed to estimate an upper bound on the PMHF. Conclusions are drawn related to the steps and methods employed, and the nature of PMHF calculation in practical real-world systems.
自2011年推出以来,ISO 26262标准为实现汽车电气和电子系统的功能安全提供了最先进的方法。在其他需求中,该标准要求使用定量故障分析技术对量化度量进行估计,例如硬件故障概率度量(PMHF)。虽然该标准提供了一些简短的指导,但文献中尚未详细描述计算PMHF的完整方法。本文将利用故障树分析(FTA)成功计算硬件故障概率度量的几个关键框架。在分析的顶层,从以前的文献中提取的方法可以用来组织复杂的多功能系统中的潜在故障。在FTA的较低级别,所有故障类别的影响,包括双点潜在故障和检测到的故障,都可以使用适当的诊断覆盖率和证明测试间隔时间来解释。本文通过一个简单的例子来说明这些方法。提出了一些简化方法来估计PMHF的上界。得出的结论与所采用的步骤和方法有关,以及实际世界系统中PMHF计算的性质。
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引用次数: 17
Future trends of electrical safety testing — Production electrical safety testing 电气安全测试的未来趋势-生产电气安全测试
Pub Date : 2016-05-16 DOI: 10.1109/ISPCE.2016.7492840
Nicholas Piotrowski
A common trend in electrical safety testing over the last several years is more stringent production line testing. Generally, only dielectric withstand and continuity tests are run as 100% routine production line testing. Equipment manufacturers have shifted away from these tests in favor of additional testing. The reason is manufacturers are performing risk analysis on product assembly procedures and determining that extra safety tests are warranted as a means of risk mitigation. New generations of production line test systems are more similar to laboratory testing systems. As a result, the more traditional laboratory testing requires a more streamlined setup to be effectively integrated into an automated setting.
在过去几年中,电气安全测试的一个共同趋势是更严格的生产线测试。一般来说,只有耐介质和连续性测试作为100%的常规生产线测试进行。设备制造商已经从这些测试转向额外的测试。原因是制造商正在对产品装配程序进行风险分析,并确定有必要进行额外的安全测试,作为降低风险的一种手段。新一代的生产线测试系统更类似于实验室测试系统。因此,更传统的实验室测试需要更精简的设置,以便有效地集成到自动化设置中。
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引用次数: 0
Model name strategy 模型命名策略
Pub Date : 2016-05-16 DOI: 10.1109/ISPCE.2016.7492849
Thomas Killam
Paper outlines the issues with compliance model numbering. The paper illustrates the benefits of choosing a Numbering strategy that allows for variations in hardware without the need to choose a model number for each variation. The paper goes on to detail the information that will benefit the manufacturer in developing compliance reports that cover a range of configurations. Additionally I provide some tips on building future updates into the framework of the report when appropriate.
论文概述了合规模型编号的问题。本文说明了选择一种编号策略的好处,该策略允许硬件的变化,而不需要为每个变化选择一个型号。本文继续详细介绍了将有利于制造商开发涵盖一系列配置的法规遵循报告的信息。此外,我还提供了一些建议,以便在适当的时候将未来的更新内容纳入报告框架。
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引用次数: 0
Medical device approval process in China since the introduction of the China Food and Drug Administration 自中国食品药品监督管理总局出台医疗器械审批程序以来
Pub Date : 2016-05-16 DOI: 10.1109/ISPCE.2016.7492842
Tobias Lueddemann, Diqing Chang, S. Şahin, T. Lueth
China's medical device market is continuously growing since the last decade and increasingly attractive for foreign medical device manufacturers. However, marketing products in China as a foreign manufacturer is challenging due to the rapidly changing regulatory environment and lack of available information and documents published in English. This work addresses the recent introduction of the China Food and Drug Administration (CFDA) and presents the current CFDA approval processes and required documentation based on research of the original documents of the CFDA in Chinese language.
近十年来,中国医疗器械市场持续增长,对国外医疗器械制造商的吸引力越来越大。然而,由于快速变化的监管环境和缺乏可用的英文信息和文件,作为外国制造商在中国营销产品具有挑战性。本文介绍了中国食品药品监督管理局(CFDA)的最新情况,并在对CFDA中文原始文件进行研究的基础上,介绍了当前的CFDA审批流程和所需文件。
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引用次数: 3
Product safety testing using induced corona detection 产品安全检测采用感应电晕检测
Pub Date : 2016-05-16 DOI: 10.1109/ISPCE.2016.7492844
D. Gies, D. Moongilan
Experiments described in this paper show corona initiated between a transformer windings using a hi-pot tester set to AC voltage output, detected with both a spectrum analyzer and a small magnetic loop and with an audio microphone. To the power transmission industry, corona is a cause of power loss and is an interference nuisance for control and communication electronics. It is understood that dielectric-voltage withstand testing (electric strength testing, or hi-pot testing) is the industry norm for determining the adequacy of insulation systems in most electrical products. However, the potential to supplement dielectric-voltage withstand testing with corona testing, perhaps as a tool for mitigation of failures, is explored. For reliable operation in a smart-grid environment, all power transformers not only should have dielectric withstanding capability, but also should not produce corona. But can corona detection be used as alternate or supplemental tool for testing insulation strength, such as for high voltage transformers that might be found in smart-grid applications, perhaps as a tool for mitigation of dielectric breakdown failures? This paper explains the phenomenon of corona, presents experiments performed for detecting induced corona, and discusses potential benefits for corona detecting in insulating materials.
本文所描述的实验表明,使用设置为交流电压输出的高罐测试仪在变压器绕组之间产生电晕,同时使用频谱分析仪和小磁环以及音频麦克风进行检测。对于电力传输行业来说,电晕是造成电力损失的原因,也是控制和通信电子设备的干扰滋扰。据了解,介电耐压测试(电强度测试或高电压测试)是确定大多数电气产品绝缘系统充分性的行业规范。然而,研究人员正在探索用电晕测试补充介电耐压测试的潜力,也许可以作为减少故障的工具。为了在智能电网环境下可靠运行,所有电力变压器不仅要具有抗介电能力,而且要不产生电晕。但是,电晕检测是否可以作为测试绝缘强度的替代或补充工具,例如智能电网应用中的高压变压器,或许可以作为减轻介电击穿故障的工具?本文解释了电晕现象,介绍了感应电晕检测的实验,并讨论了电晕检测在绝缘材料中的潜在效益。
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引用次数: 0
Preventing potential fires and hazardous situations in consumer products 防止潜在的火灾和危险情况的消费品
Pub Date : 2016-05-16 DOI: 10.1109/ISPCE.2016.7492847
S. Mozar, E. van Voorthuysen, W. Ling
Every year many consumer products such as TV sets and white goods are reported to have caught fire. In 2012, the Tokyo fire department reported that about 17% of household fires originate from consumer products. Although these figures are much better than in the past, they are still unsatisfactory. Why do consumer products become hazardous despite passing stringent testing? One of the reasons is that consumer products are generally produced in large quantities. Design evaluation and safety testing, however is only done on a very small sample, which does not represent the statistical population of the product. This paper reviews the issue of design robustness, and tolerance issues associated with large quantities such as are present in consumer products. Then it shows how statistical techniques can be adapted to safety engineering to reduce the risk of a hazardous situation occurring.
每年都有许多消费品如电视机和白色家电着火的报道。2012年,东京消防部门报告称,约17%的家庭火灾源于消费品。虽然这些数字比过去好了很多,但仍然不能令人满意。为什么消费品虽然通过了严格的测试,却变得危险?其中一个原因是消费品通常是大量生产的。然而,设计评估和安全测试只在很小的样本上进行,这并不代表产品的统计总体。本文回顾了设计稳健性问题,以及与大量相关的公差问题,例如存在于消费产品中。然后,它展示了如何将统计技术应用于安全工程,以减少危险情况发生的风险。
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引用次数: 1
Human body impedance model at radio frequencies 无线电频率下的人体阻抗模型
Pub Date : 2016-05-16 DOI: 10.1109/ISPCE.2016.7492845
D. Gies
This paper examines the frequency response of human body-simulating impedance networks found in information and communication technology safety standards, then explores their reactions at radio frequencies used for wireless telephony. It explores the possible existence of human-body inductance, resonance and skin effect. Finally, it postulates a working model for evaluating the safety of high-power circuits operating at radio frequencies.
本文研究了在信息和通信技术安全标准中发现的人体模拟阻抗网络的频率响应,然后探讨了它们在用于无线电话的无线电频率上的反应。探讨了人体电感、共振和皮肤效应可能存在的问题。最后,它假设了一个工作模型,用于评估在无线电频率下工作的大功率电路的安全性。
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引用次数: 3
Self-authentication in medical device software: An approach to include cybersecurity in legacy medical devices 医疗设备软件中的自我认证:一种将网络安全纳入传统医疗设备的方法
Pub Date : 2016-05-16 DOI: 10.1109/ISPCE.2016.7492841
Srinivasan Jagannathan, Adam Sorini
The FDA recommends that medical device manufacturers take steps to assure that appropriate safeguards are in place to reduce the risk of failure due to cyberattack, which could be initiated by the introduction of malware into the medical equipment. However, including safeguards into legacy devices in the field is not easy. One approach is to make software changes that are then distributed into the field. The problem with software-only changes is that they are easy to defeat by malicious attackers. This paper explores an approach that provides incremental security to software that is distributed in the field. Specifically, this paper describes an approach to "self-authenticate" software so that it is robust in detecting attempts to defeat security safeguards that are programmed into the compiled software code. Self-authentication relies on encrypting certain critical functions of the software so that decryption of those portions is necessary for proper operation of the device. The decrypted portions also include integrity-checking and/or authentication functions that confirm that the software has not been modified.
FDA建议医疗设备制造商采取措施,确保适当的防护措施到位,以降低因网络攻击而导致的故障风险,这可能是由于将恶意软件引入医疗设备而引发的。然而,将安全措施纳入现场的遗留设备并不容易。一种方法是对软件进行修改,然后将其分发到现场。仅对软件进行更改的问题在于,它们很容易被恶意攻击者攻破。本文探讨了一种为分布式软件提供增量安全性的方法。具体地说,本文描述了一种“自我认证”软件的方法,以便它在检测破坏已编程到编译的软件代码中的安全保护的企图方面是健壮的。自我认证依赖于加密软件的某些关键功能,因此解密这些部分对于设备的正常操作是必要的。解密部分还包括完整性检查和/或身份验证功能,以确认软件未被修改。
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引用次数: 3
Dynamic simulations of market surveillance actions 市场监督行为的动态模拟
Pub Date : 2016-05-16 DOI: 10.1109/ISPCE.2016.7492846
I. Hendrikx, N. Tuneski, Bojan Jovanoski
The Regulation No. 765/2008 of the European parliament and of the Council, Art. 2, no. 17, defines market surveillance as: "activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Community harmonization legislation and do not endanger health, safety or any other aspect of public interest protection." This paper presents a dynamic market surveillance model that takes into account the three most relevant actors within the market surveillance (MS) system: the market surveillance authority, the consumers (users of the products) and the economic operators; defines satisfactory indices for each of them, together with a set of action rules when the value of the index is below or above some (predefined) limiting value. Afterwards, computer simulation is done for a real case, the results are studied and adequate conclusions are drawn. The model given in the paper is a pioneering work and can be further developed and improved. Nevertheless, it still encompasses very well the interaction between the three parties and follows the directions given in EU Regulation No. 765/2008. It shows the dynamics of the market surveillance system and offers insight into its parameters. Thus, it can be used when improving an existing or creating a new market surveillance system.
欧洲议会和欧盟理事会第765/2008号条例,第2条,No. 6。第17条将市场监督定义为:"公共当局为确保产品符合有关共同体协调立法规定的要求而开展的活动和采取的措施,并且不危及健康、安全或保护公共利益的任何其他方面"。本文提出了一个动态的市场监督模型,该模型考虑了市场监督系统中三个最相关的参与者:市场监督当局、消费者(产品的用户)和经济经营者;为它们中的每一个定义满意的索引,以及当索引值低于或高于某个(预定义的)限制值时的一组操作规则。然后,对一个实际案例进行了计算机模拟,对结果进行了研究,得出了充分的结论。本文提出的模型是一项开拓性的工作,可以进一步发展和完善。尽管如此,它仍然很好地涵盖了三方之间的互动,并遵循了欧盟第765/2008号法规的指示。它展示了市场监控系统的动态,并提供了对其参数的洞察。因此,它可以用于改进现有的或创建新的市场监督系统。
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引用次数: 2
期刊
2016 IEEE Symposium on Product Compliance Engineering (ISPCE)
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