Pub Date : 2016-05-16DOI: 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.
{"title":"Regulatory compliance mark: For Australia/New Zealand electrical and electronic equipment","authors":"Paul W. Robinson","doi":"10.1109/ISPCE.2016.7492843","DOIUrl":"https://doi.org/10.1109/ISPCE.2016.7492843","url":null,"abstract":"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.","PeriodicalId":107512,"journal":{"name":"2016 IEEE Symposium on Product Compliance Engineering (ISPCE)","volume":"26 4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126105229","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 : 2016-05-16DOI: 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.
{"title":"Quantified fault tree techniques for calculating hardware fault metrics according to ISO 26262","authors":"Nabarun Das, W. Taylor","doi":"10.1109/ISPCE.2016.7492848","DOIUrl":"https://doi.org/10.1109/ISPCE.2016.7492848","url":null,"abstract":"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.","PeriodicalId":107512,"journal":{"name":"2016 IEEE Symposium on Product Compliance Engineering (ISPCE)","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114746202","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 : 2016-05-16DOI: 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.
{"title":"Future trends of electrical safety testing — Production electrical safety testing","authors":"Nicholas Piotrowski","doi":"10.1109/ISPCE.2016.7492840","DOIUrl":"https://doi.org/10.1109/ISPCE.2016.7492840","url":null,"abstract":"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.","PeriodicalId":107512,"journal":{"name":"2016 IEEE Symposium on Product Compliance Engineering (ISPCE)","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128225544","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 : 2016-05-16DOI: 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.
{"title":"Model name strategy","authors":"Thomas Killam","doi":"10.1109/ISPCE.2016.7492849","DOIUrl":"https://doi.org/10.1109/ISPCE.2016.7492849","url":null,"abstract":"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.","PeriodicalId":107512,"journal":{"name":"2016 IEEE Symposium on Product Compliance Engineering (ISPCE)","volume":"187 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126076367","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 : 2016-05-16DOI: 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.
{"title":"Medical device approval process in China since the introduction of the China Food and Drug Administration","authors":"Tobias Lueddemann, Diqing Chang, S. Şahin, T. Lueth","doi":"10.1109/ISPCE.2016.7492842","DOIUrl":"https://doi.org/10.1109/ISPCE.2016.7492842","url":null,"abstract":"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.","PeriodicalId":107512,"journal":{"name":"2016 IEEE Symposium on Product Compliance Engineering (ISPCE)","volume":"26 1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126152116","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 : 2016-05-16DOI: 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.
{"title":"Product safety testing using induced corona detection","authors":"D. Gies, D. Moongilan","doi":"10.1109/ISPCE.2016.7492844","DOIUrl":"https://doi.org/10.1109/ISPCE.2016.7492844","url":null,"abstract":"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.","PeriodicalId":107512,"journal":{"name":"2016 IEEE Symposium on Product Compliance Engineering (ISPCE)","volume":"75 5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123219080","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 : 2016-05-16DOI: 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.
{"title":"Preventing potential fires and hazardous situations in consumer products","authors":"S. Mozar, E. van Voorthuysen, W. Ling","doi":"10.1109/ISPCE.2016.7492847","DOIUrl":"https://doi.org/10.1109/ISPCE.2016.7492847","url":null,"abstract":"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.","PeriodicalId":107512,"journal":{"name":"2016 IEEE Symposium on Product Compliance Engineering (ISPCE)","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122978540","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 : 2016-05-16DOI: 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.
{"title":"Human body impedance model at radio frequencies","authors":"D. Gies","doi":"10.1109/ISPCE.2016.7492845","DOIUrl":"https://doi.org/10.1109/ISPCE.2016.7492845","url":null,"abstract":"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.","PeriodicalId":107512,"journal":{"name":"2016 IEEE Symposium on Product Compliance Engineering (ISPCE)","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134365247","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 : 2016-05-16DOI: 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.
{"title":"Self-authentication in medical device software: An approach to include cybersecurity in legacy medical devices","authors":"Srinivasan Jagannathan, Adam Sorini","doi":"10.1109/ISPCE.2016.7492841","DOIUrl":"https://doi.org/10.1109/ISPCE.2016.7492841","url":null,"abstract":"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.","PeriodicalId":107512,"journal":{"name":"2016 IEEE Symposium on Product Compliance Engineering (ISPCE)","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123710125","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 : 2016-05-16DOI: 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.
{"title":"Dynamic simulations of market surveillance actions","authors":"I. Hendrikx, N. Tuneski, Bojan Jovanoski","doi":"10.1109/ISPCE.2016.7492846","DOIUrl":"https://doi.org/10.1109/ISPCE.2016.7492846","url":null,"abstract":"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.","PeriodicalId":107512,"journal":{"name":"2016 IEEE Symposium on Product Compliance Engineering (ISPCE)","volume":"38 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127774931","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}