Pub Date : 2019-05-01DOI: 10.1109/ISPCE.2019.8771344
Craig N Harvey, J. Magby, D. Urbach-Ross, Dan Roman
Paper will discuss chemical substances sometimes found in electronic products that get bad press, but for which there is not always sound toxicological science that should require bans at levels used.
{"title":"(Im)Perfectly Safe","authors":"Craig N Harvey, J. Magby, D. Urbach-Ross, Dan Roman","doi":"10.1109/ISPCE.2019.8771344","DOIUrl":"https://doi.org/10.1109/ISPCE.2019.8771344","url":null,"abstract":"Paper will discuss chemical substances sometimes found in electronic products that get bad press, but for which there is not always sound toxicological science that should require bans at levels used.","PeriodicalId":374638,"journal":{"name":"2019 IEEE International Symposium on Product Compliance Engineering (ISPCE)","volume":"96 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133182695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-01DOI: 10.1109/ISPCE.2019.8771340
H. Sasaki
The products have to comply with the regulations and standards. Once the product is not complied with, the defensive actions taken but keep the product being complied with the offensive actions are necessary. Explaining these examples; changed IEC standards in my experience, suggesting that the compliance can be realized by the human resources.
{"title":"My experience of Product Compliance - Motivation to change IEC standards","authors":"H. Sasaki","doi":"10.1109/ISPCE.2019.8771340","DOIUrl":"https://doi.org/10.1109/ISPCE.2019.8771340","url":null,"abstract":"The products have to comply with the regulations and standards. Once the product is not complied with, the defensive actions taken but keep the product being complied with the offensive actions are necessary. Explaining these examples; changed IEC standards in my experience, suggesting that the compliance can be realized by the human resources.","PeriodicalId":374638,"journal":{"name":"2019 IEEE International Symposium on Product Compliance Engineering (ISPCE)","volume":"388 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133549236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-01DOI: 10.1109/ISPCE.2019.8771345
D. Gies
This paper examines the optical safety considerations of free-space optical communication systems (FSOC). These telecommunication systems communicate over distances through free space using optical communication technology. Topics include eye safety, restricted access, IEC 60825–1 and IEC 60825–12 compliance, and safety considerations for aviation pilots from laser light. FSOC systems would be expected to comply with IEC 62368–1, coordinated with IEC 60950–22 for outdoor systems, as well as the aforementioned IEC 60825 standards.
{"title":"Safety of Free-Space Optical Communication Systems","authors":"D. Gies","doi":"10.1109/ISPCE.2019.8771345","DOIUrl":"https://doi.org/10.1109/ISPCE.2019.8771345","url":null,"abstract":"This paper examines the optical safety considerations of free-space optical communication systems (FSOC). These telecommunication systems communicate over distances through free space using optical communication technology. Topics include eye safety, restricted access, IEC 60825–1 and IEC 60825–12 compliance, and safety considerations for aviation pilots from laser light. FSOC systems would be expected to comply with IEC 62368–1, coordinated with IEC 60950–22 for outdoor systems, as well as the aforementioned IEC 60825 standards.","PeriodicalId":374638,"journal":{"name":"2019 IEEE International Symposium on Product Compliance Engineering (ISPCE)","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123416717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-01DOI: 10.1109/ISPCE.2019.8771343
J. Hatcliff
Health care delivery is increasingly relying on interoperable components and medical systems built from those components. Existing life-cycle processes found in medical device standards such as IEC 62304 do not adequately address the complexities associated with interoperable medical components and systems. Interoperable medical systems and their associated components may be developed, operated, and maintained by many different organizations. Such systems may be built using platform concepts designed to facilitate reuse of both platform infrastructure and assurance artifacts when the platform is used to build different systems. Life-cycle processes supporting conformity assessment of these products would benefit from explicitly addressing issues such as (a) multi-organization development, risk management, and assurance, (b) life-cycle activities that guide interactions between organizations, (c) product-line development and other notions of explicitly managed reuse, and (d) integration and reuse of components at arbitrary levels of abstraction in the system hierarchy. In this paper, we provide an overview of life-cycle issues for interoperable medical products that are not sufficiently addressed in existing medical device standards. We expose issues that need to be considered in designing life-cycle processes for this space that can guide standards development activities and conformity assessment organizations. To help indicate possible directions, we identify lifecycle concepts from other domains that may adapted for interoperable medical systems.
{"title":"Challenges and Directions for Lifecycle Processes Supporting Conformity Assessment of Interoperable Medical Products","authors":"J. Hatcliff","doi":"10.1109/ISPCE.2019.8771343","DOIUrl":"https://doi.org/10.1109/ISPCE.2019.8771343","url":null,"abstract":"Health care delivery is increasingly relying on interoperable components and medical systems built from those components. Existing life-cycle processes found in medical device standards such as IEC 62304 do not adequately address the complexities associated with interoperable medical components and systems. Interoperable medical systems and their associated components may be developed, operated, and maintained by many different organizations. Such systems may be built using platform concepts designed to facilitate reuse of both platform infrastructure and assurance artifacts when the platform is used to build different systems. Life-cycle processes supporting conformity assessment of these products would benefit from explicitly addressing issues such as (a) multi-organization development, risk management, and assurance, (b) life-cycle activities that guide interactions between organizations, (c) product-line development and other notions of explicitly managed reuse, and (d) integration and reuse of components at arbitrary levels of abstraction in the system hierarchy. In this paper, we provide an overview of life-cycle issues for interoperable medical products that are not sufficiently addressed in existing medical device standards. We expose issues that need to be considered in designing life-cycle processes for this space that can guide standards development activities and conformity assessment organizations. To help indicate possible directions, we identify lifecycle concepts from other domains that may adapted for interoperable medical systems.","PeriodicalId":374638,"journal":{"name":"2019 IEEE International Symposium on Product Compliance Engineering (ISPCE)","volume":"68 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129892427","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-01DOI: 10.1109/ISPCE.2019.8771341
R. Nute
Product markings and labels provide information about the product, installation, and use. The markings and labels can also provide warnings to avoid hazardous energy transfer to a body part. The product safety aspects of markings for identification, ratings, functions, connections, and warnings are described.
{"title":"Product Markings and Labels","authors":"R. Nute","doi":"10.1109/ISPCE.2019.8771341","DOIUrl":"https://doi.org/10.1109/ISPCE.2019.8771341","url":null,"abstract":"Product markings and labels provide information about the product, installation, and use. The markings and labels can also provide warnings to avoid hazardous energy transfer to a body part. The product safety aspects of markings for identification, ratings, functions, connections, and warnings are described.","PeriodicalId":374638,"journal":{"name":"2019 IEEE International Symposium on Product Compliance Engineering (ISPCE)","volume":"280 3","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132419541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-01DOI: 10.1109/ISPCE.2019.8771342
L. F. Bilancia, Ashley M. Giesa, Keith G. Cline
Different wavelengths of the electromagnetic spectrum can cause injury to exposed living tissue inside and outside of the body-sunburn is a common demonstration of this. In this case study, due to an apparent lack of education and training, hospital maintenance and/or cleaning staff erroneously removed the infrared and ultraviolet filters from a halogen bulb operatory luminaire which resulted in harmful radiation exposure to hospital staff and patients. It is estimated that more than 1000 individuals could have been exposed to the unfiltered light and several were diagnosed with severe tissue damage. At least one case was untreatable. This paper outlines the instrumentation and calculations performed to evaluate the severity of the exposure risk to unfiltered artificial light.
{"title":"Illumination Caused Permanent Bodily Injury, Photons Not Taken Lightly","authors":"L. F. Bilancia, Ashley M. Giesa, Keith G. Cline","doi":"10.1109/ISPCE.2019.8771342","DOIUrl":"https://doi.org/10.1109/ISPCE.2019.8771342","url":null,"abstract":"Different wavelengths of the electromagnetic spectrum can cause injury to exposed living tissue inside and outside of the body-sunburn is a common demonstration of this. In this case study, due to an apparent lack of education and training, hospital maintenance and/or cleaning staff erroneously removed the infrared and ultraviolet filters from a halogen bulb operatory luminaire which resulted in harmful radiation exposure to hospital staff and patients. It is estimated that more than 1000 individuals could have been exposed to the unfiltered light and several were diagnosed with severe tissue damage. At least one case was untreatable. This paper outlines the instrumentation and calculations performed to evaluate the severity of the exposure risk to unfiltered artificial light.","PeriodicalId":374638,"journal":{"name":"2019 IEEE International Symposium on Product Compliance Engineering (ISPCE)","volume":"36 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124186761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-01DOI: 10.1109/ISPCE45810.2019.9248728
Michelle L. Kuykendal, D. Kingsley, A. Arora
Tin whiskers are small, hair-like structures that can form naturally from the surface of tin components. While the mechanisms by which tin whiskers form are poorly understood, their potential effects are well documented: they can cause short circuits and arcs within electrical devices, damage micro-electromechanical systems (MEMS), and interfere with the operation of optical and RF components. As automotive systems become increasingly reliant on integrated electronics, the potential for reduced functionality or damage resulting from tin whisker formation increases; however, because the factors that contribute to whisker growth are still debated, design practices, testing standards, and mitigation processes to address tin whiskers have not matured. We discuss potential contributors to tin whisker growth, failure mechanisms that may be induced by whiskers, current testing standards and processes, and mitigation strategies, with a particular focus on the automotive industry.
{"title":"The Impact of Tin Whisker Formation on Vehicle Electronics","authors":"Michelle L. Kuykendal, D. Kingsley, A. Arora","doi":"10.1109/ISPCE45810.2019.9248728","DOIUrl":"https://doi.org/10.1109/ISPCE45810.2019.9248728","url":null,"abstract":"Tin whiskers are small, hair-like structures that can form naturally from the surface of tin components. While the mechanisms by which tin whiskers form are poorly understood, their potential effects are well documented: they can cause short circuits and arcs within electrical devices, damage micro-electromechanical systems (MEMS), and interfere with the operation of optical and RF components. As automotive systems become increasingly reliant on integrated electronics, the potential for reduced functionality or damage resulting from tin whisker formation increases; however, because the factors that contribute to whisker growth are still debated, design practices, testing standards, and mitigation processes to address tin whiskers have not matured. We discuss potential contributors to tin whisker growth, failure mechanisms that may be induced by whiskers, current testing standards and processes, and mitigation strategies, with a particular focus on the automotive industry.","PeriodicalId":374638,"journal":{"name":"2019 IEEE International Symposium on Product Compliance Engineering (ISPCE)","volume":"5 1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117127263","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-01DOI: 10.1109/ISPCE.2019.8771346
P. E. Perkins
Based upon his 1943 paper Professor Charles F Dalziel extended his Let-go effects analysis to mixed AC and DC waveforms plus various shaped nonsinusoidal waveforms to determine reasonable safe current limits feeling that it could be applied to any waveform. This paper revisits his analysis and extends it to modern non-sinusoidal waveforms to provide a substantiation for application of this analysis to nonsinusoidal touch currents found in modern electronic equipment.
根据他1943年的论文，Charles F Dalziel教授将他的放手效应分析扩展到混合交流和直流波形以及各种形状的非正弦波形，以确定合理的安全电流限制，感觉它可以应用于任何波形。本文回顾了他的分析，并将其扩展到现代非正弦波形，为将该分析应用于现代电子设备中的非正弦触摸电流提供了依据。
{"title":"Dalziel revisited 75 years later; analysis of mixed bipolar and monopolar waveforms","authors":"P. E. Perkins","doi":"10.1109/ISPCE.2019.8771346","DOIUrl":"https://doi.org/10.1109/ISPCE.2019.8771346","url":null,"abstract":"Based upon his 1943 paper Professor Charles F Dalziel extended his Let-go effects analysis to mixed AC and DC waveforms plus various shaped nonsinusoidal waveforms to determine reasonable safe current limits feeling that it could be applied to any waveform. This paper revisits his analysis and extends it to modern non-sinusoidal waveforms to provide a substantiation for application of this analysis to nonsinusoidal touch currents found in modern electronic equipment.","PeriodicalId":374638,"journal":{"name":"2019 IEEE International Symposium on Product Compliance Engineering (ISPCE)","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122494571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-01DOI: 10.1109/ispce.2019.8771347
L. F. Bilancia, D. Mann
{"title":"Arson Under the Christmas Tree","authors":"L. F. Bilancia, D. Mann","doi":"10.1109/ispce.2019.8771347","DOIUrl":"https://doi.org/10.1109/ispce.2019.8771347","url":null,"abstract":"","PeriodicalId":374638,"journal":{"name":"2019 IEEE International Symposium on Product Compliance Engineering (ISPCE)","volume":"78 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126170615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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