The Product What’s Inside Safety - IEEE Entity Web Hosting · ing the VPs (Membership Services,...

Vol. 6 No. 2 IEEE PSES Product Safety Engineering Newsletter

The

ProductSafetyEngineeringNewsletter

Vol. 6, No. 2 June 2010

President’s Message

What’s InsidePresident’s Message .......................... 1

Officers of the IEEE PSES ................ 2

Chapter Activities .................................... 20

A New Approach to Product safety ................. 5

Medicial Electrical Safety Under Attack ........ 11

News and Notes............................... 7

Continued on Page 3

This has been an exciting time for me! And a frus-trating time, as I would like to be in a better posi-tion to provide much more for our members. Oursituation is not quite or the same magnitude as aDickens novel, but we are in a critical phase inour development into a successful IEEE Society.

First, the high points of the past few months: InApril, I went to Beijing for our first Beijing ProductSafety Engineering Workshop. It was a great cul-mination of a number of meetings to try to get aBeijing PSES chapter up and running. ThomasHa, our VP of Membership, and Paul Wang ourIEEE PSES Region 10 Representative were greathosts, introducing me to a number of potentialleaders for the Beijing Chapter. China QualityCertification and CQC Testing Technical Servicesdid a great job hosting the event.

We were very fortunate that a TC-108 meeting inBeijing had some of our preeminent speakers inBeijing. Bob Griffin, A. Hessami, Peter Keller, RichNute, Peter Perkins and Rich Pescatore gave pre-sentations of their work. A lot of material was cov-ered! Mark Montrose, IEEE Division VI Director

and first president of thePSES told the attendeesabout the history ofPSES. Thomas Ha wentover the benefits of IEEEPSES membership.

The 120 attendeesseemed intrigued by thewealth of information. Our hosts provided nour-ishment during breaks and the luncheon. So it wasa very productive day!

As I write this, the Beijing Chapter is in its forma-tive stages. As I told anyone who would listen, oursociety is here to serve the product safety profes-sional—engineers, technicians, administratorsand managers: anyone whose career involvesproduct safety and regulatory issues. It’s a forumfor professional development that exists only toserve its members.

Part of the PSES success will be due to leader-ship and leadership development, which I think isan important part of our profession. With a num-

http://www.ieee-pses.org/newsletters.html

http://www.ieee.org/

http://www.ieee-pses.org/

http://www.ieee.org/portal/pages/about/awards/noms/potnomform.html


The


The Product Safety Engineering Newsletter is published by the IEEE Product Safety Engineer-ing Society. No part of this newsletter may be reproduced without written permission of theauthors. All rights to the article remain with the authors.

Opinions expressed in this newsletter are those of the authors and do not necessarily representthe opinions of the Society or any of its members. Indeed, there may be and often are substan-tial disagreements with some of the opinions expressed by the authors.

Copyright 2010 IEEE Product Safety Engineering Society.

IEEE PSES Web Siteshttp://www.ieee-pses.org/http://www.ieee-pses.org/symposium/http://www.ieeecommunities.org/emc-pstchttp://www.ieee-pses.org/emc-pstc.htmlhttp://www.ieee-pses.org/newsletters.htmlhttp://www.ieee-pses.org/pses.html

IEEE PSES Officers

Newsletter CommitteeEditor:

Gary Weidner 1-563-557-0717 (v) 1-563.557.0725 (fax) [email protected]:

Michael S. Morse Ph. D. [email protected] Nute r i c h n @ i e e e . o r gNosh Medora [email protected] Bahra L a l _ B a h r a @ D e l l . c o mLingfeng Chen [email protected]

News & Notes:Your name here

Chapter Acitivities:Your name here

Page Layout:Jim Bacher 1-937.865-2020(v) 1-937.865.2048 (fax) [email protected]

Executive Committee Name TermPresident Murlin Marks (10-11)Past President Jim Bacher (10-11)President Elect TBD (11)Secretary Daniece Carpenter (09-10)Treasurer Jan Swart (10-11)Vice President - Communications Dan Roman (09-10)Vice President - Member Services Thomas Ha (09-10)Vice President - Technical Activities Jack Burns (09-10)Vice President - Conferences Dough Nix (10)

Directors At LargeTerm Expires 12/10 Term Expires 12/11 Term Expires 12/12 Ex Officio (without vote)Jim Bacher Jack Burns Daniece Carpenter Chapter ChairsSilvia Diaz Monnier Jim Pierce Richard Georgerian Standing Committee ChairsDoug Nix Richard Pescatore Elya Joffe IEEE HQPeter Tarver Ivan Vandewege Rich Nute IEEE TAB Division VI Director

Douglas Kealey Gold Member: Open

http://www.ieee-pses.org/

http://www.ieee-pses.org/symposium/

http://www.ieeecommunities.org/emc-pstc

http://www.ieee-pses.org/emc-pstc.html

http://www.ieee-pses.org/newsletters.html

http://www.ieee-pses.org/pses.html

mailto:[email protected]















ber of leaders in China and in Beijing in particular,we can build active chapters that will provide meet-ings, workshops and other activities for its mem-bers. Having a number of leaders also means thatthe workload can be broken down to manageablelevels.

On my return from China, I stopped in Osaka,Japan to discuss setting up one or more IEEEPSES chapters in Japan. I discussed our societywith several executives; I hope this discussionhelps to get things started in Japan. I do think thatthe PSES offers product safety engineers in Ja-pan the opportunity to participate in a professionalforum, but it’s up to a few key leaders who havethe vision and access to industry to set things inmotion.

I also attended Santa Clara Valley Chapter meet-ings. The last one was particularly good. It was ajoint meeting with the IEEE Reliability Society, withabout 50 attendees. It was a great meeting; thekind of stimulating discussion with chapter regu-lars and a number of individuals with a somewhatdifferent perspective. The topic was probably thesafety issue of the day—How to Avoid Being theNext Toyota. You can find the presentations atw w w . e w h . i e e e . o r g / r 6 / s c v / p s e s /ieee_scv_pses_apr10.pdf . All PSES chaptermeetings may not be quite as much in the publicfocus, but they do offer a unique opportunity toconsider wider aspects of product safety issues.It was particularly satisfying to me to know thatone of our Technical Committees (Risk Assess-ment) had helped get access to engineers at theforefront of the issue.

The excellence of the April Santa Clara Chaptermeeting leads me to my present frustrations. Wehaven’t yet convinced IEEE that PSES serves avital engineering discipline worthy of IEEE soci-ety status. My frustration is that I see our potentialas a vital IEEE society, but I don’t see us function-ing that way yet. Even with a number of peoplemaking significant efforts, I don’t think we are cur-rently “viable” as IEEE sees it – and, perhaps notas important but not as I see it either. There, Isaid it.

I know everyone has to earn a living, and therejust isn’t any time left. That’s why it’s crucial untilPSES is large enough, with conferences and jour-

nals to bring in the funding to support a staff to dothe leg work, that we have many people sharingthe load. Each chapter needs at least a half dozenpeople willing to plan and coordinate meetings.Conferences need to be planned and budgeted,with a flow of papers, exhibitors and sponsors.Technical Committees need to stimulate an ad-equate conference and Newsletter paper flow andprovide chapter meeting presenters so that chap-ters can plan out meetings well in advance andbuild a solid attendance. We need active dissemi-nation of all this “stuff” going on.

Right now, we are functioning on a single cylin-der. A few folks are spending a lot of their timetrying to do certain tasks. But things for the mostpart aren’t falling in place. Others for whateverreason haven’t done what they said they woulddo. Others have said they are interested, but theyhaven’t taken on any tasks.

The irony is that we are nearly there. We have anumber of chapters, we have the Newsletter, wehave a tradition of successful conferences, andwe know how to put technical papers together.We can operate in the black within the IEEE struc-ture. But those of us who are putting the effortinto the PSES cannot hold it together. We need tohave most of our chapters running with plannedout schedules to have well-attended meetings—Ibelieve that the biggest value to PSES and po-tential PSES members is having regular meetingscovering timely topics. We need conferences thathave enough margins to keep the society in theblack. We need a technical operation that sup-ports a paper and presentation flow. I don’t thinkit’s really very difficult, but it does require the manyhands of a “society.”

I remember back when I was an assignment en-gineer at UL. Back in those days, our main effortwas to close out projects, not to get to compli-ance and certification. I was pretty successful, butvery busy going back and forth with my clients.Some got certification; some didn’t. Those thatdidn’t always knew what the issues were. Manyengineers back then often extended due dates(promise dates as we called them). They gener-ally said that they had done what they needed todo, but were waiting for information or samples –the ball was in the client’s court. They had donetheir part. The point is that those of us who made



most of our commitments always figured that wehad to go more than half way to get the job done.That’s where we are with the PSES. We all needto do a bit more than the minimum. If you joinPSES and think that the society will be everythingyou want it to be if you nominally participate, wewon’t make our promise date.

Our vision is for a professional society. That meansthat we, as “professionals” (and that doesn’t meanyou have to be an engineer – just someone whohas a serious career related to product safetyengineering; you could be a technician or an ad-ministrator or an engineer) must build our societyto help our profession, our careers and our com-panies. A few of us can’t do that for you.

In late June, I will sit down with the IEEE SocietyReview Committee and make the case of whyPSES should continue in its present structurewithin IEEE. I want to present the best case I can,but I need your help. Please look at where youhave a good fit in your local chapter, in a technicalcommittee, a conference committee, or support-ing the VPs (Membership Services, Technical Ac-tivities, Communication, and Conferences). I doask that if you take on a task, you get it done withinthe necessary parameters. If all members do theirpart, we will make it.

Finally, please let me know what I can do to pro-vide support. I have some time for supportingPSES, but rather limited resources. I am willing todo a bit more than what is “reasonable,” but can-not pull a society together on my own or even withthe help of a few as we are currently operating.

Murlin MarksPresident IEEE PSES

Tip: Best way to getyour boss to approveyour trip to the 2009Symposium on Com-pliance Engineering isto submit a paper thatgets accepted for thesymposium! Or volun-teer and tell him youhave to be there!




A NEW APPROACH TO PRODUCT SAFETY

The narrowing distinction between IT (informationtechnology) at home and as professionalentertainment products has created a need toharmonize related safety requirements. Theincreasing proliferation of audio, video, information,and communication technology equipment alsomeans that safety needs of children, the elderly andthe disabled must be taken into consideration. Inaddition, the safety requirements must keep up withthe rapid advancement in technology for theseproducts. All of this has changed the way the IEClooks at safety standards for these products.

In the past, an IEC standard was typicallyprescriptive, describing specific constructions. Forexample, the traditional standard would indicateexactly the size for a ventilation opening in a productfor it to comply with safety requirements. Today,such guidelines can prove limitative to new productdesigns and may become obsolete when technologyevolves.

TC (Technical Committee) 108: Safety of electronicequipment within the field of audio/video, informationtechnology and communication technology,addressed this challenge by moving from a product-driven safety analysis to a systemic identificationand analysis of hazards using an approachcommonly referred to as Hazard-Based SafetyEngineering (HBSE).

TC 108 developed a new standard, IEC 62368-1,Audio/video, information and communicationtechnology equipment - Part 1: Safety requirements.It clearly states the risk being addressed and itsprinciples for compliance. To the extent practicable,compliance statements are performance-based.However, to minimize testing, acceptableconstructions are also provided for a designer’s use,if they so choose.

From reactive to proactiveTypically, the differences can be illustrated bycomparing the approach in a standard such as IEC60065, Audio, video and similar electronic apparatus– Safety requirements, which is incident-based andproduct-specific, with that of the new IEC 62368,which is technology-independent and based on

performance as opposed to construction. The formertakes a reactive approach while the latter isproactive in its direction.

No longer product-specificBeing technology-independent, the standard isbased on sound engineering principles. It is destinedto be used by engineers who designed the productand evaluated its safety requirements. It is alsointended to be used by first, second or third partiesassessing conformance of products.

Scope for innovationSays Richard L. Pescatore, Global Product SafetyStandards Development and Certification Managerat Hewlett-Packard Company and Convenor of TC108/WG HBSDT, “From now on, the designer, whengoing through the engineering and safety analysisof a product, will understand what is needed to makethat product safe. He will no longer be bound byspecific required constructions. Instead, he willunderstand the hazard being addressed and thecriteria for mitigating the hazard. This will give himtremendous design freedom.”

IEC 62368-1, is different from anything the IEC haswritten to date in the area of product safety. Thehope is that 10 years from now, a design engineerwill understand the objective of a given safetyguideline so that the intent of the requirements isnot lost over time. Tremendous work has beenexpended in developing this standard. TC108started working on this generic approach back in2002. The result is that now a new separate standardwill not have to be developed every time thetechnology changes in the market.

Safety is paramount in conformity assessmentIEC 62368-1 is a very important standard too forConformity Assessment (CA). Seventy per cent ofall IECEE CA certificates issued each year concernsafety in the three major industries under the scopeof IEC 62368-1: communication technology,information technology and consumer electronics.IECEE is the System of Conformity Testing andCertification for Electrotechnical Equipment andComponents. TC 108 has also adopted a proactiverole in reducing potential negative impact of



technology on the environment, while preservingproduct safety properties. Another area of intensivework is related to energy efficiency.

Current product safety standards:Incident-based standardThis type of standard takes into account par-ticular incidents that analysis has shown canbe prevented provided certain safety measuresare taken. An example would be the case of anexternal power supply that overheats, or wherethere’s a risk of it catching fire. An incident-based standard therefore includes particular re-quirements to prevent mechanical movementof the connector and thus recurrence of theparticular incident.Product-specific standardThe standard is written for a specific productor product group. IEC 60065 is specific to con-sumer electronics such as TVs, audio systems,etc. IEC 60950-1, Information technologyequipment – Safety – Part 1: General require-ments, is written for computers and relatedequipment.Construction-based approachThe standard specifies the actual constructionsthat make the product safe. Other constructions(which may be equally safe) are prohibited. Anexample of this could be a ventilation openingthat must be of a specific size.Reactive approachThe requirements of the standard mean that itprovides for reactions to incidents or near-inci-dents, much in the way of an “incident-based”standard. An example here might be a reac-tion to field complaints that results in a mechani-cal securement of the power input connectoron external power supplies.

IEC 62368:Hazard-based standardThe standard is based on the energy sourceswithin the equipment. The publication classesthe energy sources as either hazardous or non-hazardous. Example: Voltages above a certainlevel are hazardous, while those below a cer-tain level are non-hazardous.Technology-independentThe standard addresses safeguards againstspecific energy sources, independent of thefunction of the product. In today’s world, com-puters and TVs are becoming complementaryequipment, so the safety standard must bewritten to account for technology, not specificproducts. Example: The principles for protec-tion against any energy source are applicableto any technology existing today and any fu-ture technology.Performance-basedIt is the safety performance of the equipmentthat is specified, not the construction. For ex-ample concerning the assembly of a power in-put connector of an external power supply, it isspecified that it shall not stress the electricalconnections.Proactive approachThe standard addresses the sources of energycontained in the equipment. This allows haz-ardous energy to be anticipated and safeguardsto be designed to prevent future safety inci-dents. This can be illustrated by solder which,under stress, is subject to cold-flow. If the con-nection were to fail and result in a hazardouscondition, then the failure would need to beprevented, or the consequences of a failedconnection mitigated.

Change in approachFrom reactive to proactive, product-based to generic, the systems approach

Reprinted with permission from the January-February 2010 issue of IEC E-TECH.


Continued on Page 8

News and Notes

EN 60950 Deadline is ApproachingThe date of withdrawal/date of cessation for EN60950-1:2006 is 1 December 2010, so productsmanufactured and declared in conformance withit will not be permitted on the EU market after thatdate. Certificates issued after December 1st mustinclude EN 60950-1:2006 (Ed. 2) + A11. The modi-fications caused by A11 particularly relate to com-ponents.

(Information provided by Nemko. For more details,visit www.nemko.co.uk/node/136.)

University of Wisconsin Annual Product Liabil-ity ConferenceThe University of Wisconsin (Madison, Wiscon-sin, USA) has scheduled its 22nd annual productliability conference for 28–30 September, 2010.Topics to be covered include:·Product liability lawsuits;·Consumer products safety improvement act·Avoiding development of a “defective” product;·Liability and risk assessment of materials;·Liability and nanotechnology;·Finding, selecting, and utilizing an expert witness;·Principles for analyzing product defects;·Managing warnings and instructions;·What to do when learning of adverse informationabout suppliers’ products or processes.

For more information, visit:http://epd.engr.wisc.edu/emaL451.

Call for Papers—2010 PSES SymposiumA call for papers has been issued for the 2010PSES Product Compliance Engineering sympo-sium. Requested are original, unpublished papersand tutorials on all aspects of product safety andcompliance engineering, including topics such asthese:· Product-specific topics;· Hazard-specific topics;· EMC/RF;· Components;· Certification;· Standards activities;· Research;· Environmental;

· Demonstrations.

The symposium will be held 18–20 October, 2010at the Boston Marriott Burlington hotel. The sched-ule for authors is as follows:· Submission of intent to present, and topic, 30June, 2010;· Draft e-paper, 30 June, 2010;· Notification of acceptance, 30 July 2010;· Complete e-paper submitted, 30 August, 2010.

Prospective authors should submit e-papers us-ing the on-line submission system provided at thesymposium web site, www.psessymposium.org.Comprehensive submission instructions at theweb site include paper templates.

News from Technical Activities Committees(TAC)As you may have read in the previous issue, PSEShas a secret—or maybe that should be HAD asecret—and that is its Technical Activities Com-mittees. We now have five Technical ActivitiesCommittees up and running and several more inprogress. We have room for as many as there isan interest in forming and we welcome sugges-tions for new ones, These committees serve thepurpose of providing the connection of PSES toeach of the many industry and technical groupswhich have an interest in product safety. It is be-yond the capability of the PSES Board of Direc-tors to know what is going on everywhere andwhere we need to focus attention. The TechnicalCommittees serve that purpose for us and ensurethat their industry groups are getting what theyneed from the Society. At present the followingcommittees are active with monthly leadershipconference calls and email lists either active orforming:

· Medical Product Safety TC (Dr Sandy Weininger,Chair);· Forensic and Failure Analysis TC (IvanVandewege, Chair);· Risk Analysis TC (Doug Nix, Chair);· Telecom Safety TC (Peter Tarver, Chair);· Computers and ITE TC (Gary Schrempp, Chair).



In addition, interest has been shown for the fol-lowing TCs which are now trying to form and be-come active: Laser Product Safety, ConsumerProducts, and Industrial Equipment and Control.

In case you didn’t know, all it takes to form a TC isfor a couple of leaders to step forward (only oneneeds to be a member of PSES) and find at leasttwo others for a total of four—not all from the sameorganization or geographical area. Send me anemail or give me a call and I’ll set up an organiza-tional conference call, and we’ll go from there. It’sreally very easy and simple, and it provides anexcellent way to hone your leadership skills, meetother leaders, and do something good for thePSES and your industry. We’ve got lots of help togive you and we’ll get enough people involved sothat no one has too great a burden. For my con-tact information and that of the TC Chairs, and formore information about Technical Committees,click on “Technical Committees” on the PSEShome page (www.ieee-pses.org/technical.html).

Jack BurnsPSES VP, Technical [email protected]

TAC for ITE/Computers is Being Formed

Any parties interested in contributing to the for-mation of this group should contact GarySchrempp ([email protected]).

Medical Safety TCThe Medical Safety Technical Committee imple-mented a listserv to share discussions regardingmedical device issues. We were successful at thelast PSES conference in assembling a dedicatedtrack with topics on design, hazard analysis, andthe standards landscape. Our current efforts aretrying to get useful information into the listserv.

Risk Assessment TCActivities Report—May 2010Doug Nix, Chair

The Risk Assessment Technical Committee meetsmonthly to discuss risk assessment topics thatrelate to product safety engineering. We recentlyset our Field of Interest and our Mission. If these

areas of work sound interesting to you, pleasecome to our next meeting!

Field of InterestThe PSES Risk Assessment Technical Commit-tee Field of Interest is the development and appli-cation of risk assessment methodology in thetheory, design, development and implementationof electronic and electromechanical equipmentand devices and the embedded control softwareand firmware used in those devices.

MissionThe Risk Assessment Technical Committee iscommitted to becoming a center of excellence inrisk assessment. The committee will pursue thisgoal by creating a core group of experts in thefield to guide the activities of the Committee.

The TC will provide guidance and information toanyone who needs this information, including otherPSES TCs, IEEE Societies, Standards Develop-ment Organizations, Regulatory Authorities, Cer-tification Bodies, Producers of electronic and elec-tromechanical products, and users of those prod-ucts.

The TC will disseminate risk assessment knowl-edge to users through publication of papers andreports through the PSES, and by providing asource of speakers for Society and Chapter meet-ings.

MembershipThe Executive Committee of the TC is a fairly smallgroup of individuals who are responsible for set-ting the tone and the agenda for the committee asa whole. I have been Chair of the TC for the lastfew months, but my recent appointment to VPConferences means that I have had to give thisrole up. At our June meeting, Daren Slee fromExponent graciously agreed to take the Chair fromme. I want to welcome Daren to this role. He isvery experienced in forensic engineering and fail-ure analysis and will bring much to the RATC incoming months.

RATC Chair: Daren Slee ([email protected])RATC Secretary: Tom Doyle([email protected])RATC Communications: Steve Lawrence


Continued on Page 10

([email protected])

CalendarOur calendar is posted on the TAC page withinthe PSES Society site at www.ieee-pses.org/technical.html. You can subscribe to the calendarto keep our activities updated in your personalcalendar too.

Work ProgramThe committee is drafting their initial work programnow. Currently being considered for inclusion are:

1. Terminology—work on developing guid-ance on the correct terminology relating to riskassessment.2. Scoring Tools—develop criteria for judg-ing the effectiveness and usefulness of variousscoring tools that are available (i.e. PHA, FMEA,FTA, HazOP, etc.), and then develop a list of re-viewed and recommended tools for members toconsider for use.3. Develop guidance on selection of qualita-tive, semi-quantitative and quantitative risk as-sessment methods. How can you decide whichapproach to take? What are the implications ofchoosing one method over another?4. Develop guidance on the output from therisk assessment process, and the communicationof that information to the user.5. Develop guidance on how to relate statis-tical measures of probability, i.e. 1x10-6 occur-rences per year = ? in layman’s terms?6. Develop a link guide for risk assessmentresources on the web.7. Develop guidance on how to set risk as-sessment criteria based on the target market, i.e.consumer products vs. industrial products (work-place OHS) vs. medical products.

If you are interested in working on any of thesetopic areas, please contact the committee andvolunteer your expertise! If you would like to seeother items added to the future work program, thecommittee wants to hear from you. Please con-tact us!

This will be my last report as Chair, as my newduties as VP, Conferences are absorbing all thetime I can make available this year. Thank you all

for the opportunity to get this important commit-tee off to a flying start. I look forward to continuingto work with the group as my time permits. Pleaseoffer your support to Daren Slee as he takes overthis strong group!

The Telecom Safety Technical Committee(TSTC) website and email list are being set up.TSTC meets the third Wednesday of every monthat 8:00 AM Pacific time. Contact Peter Tarver([email protected]) for details. Join ourTSTC Subgroup of PSES on LinkedIn. Topicscurrently being worked on include:

· Cell phone base stations using inad-equately vented VRLA batteries that have led tobatteries overheating and exploding· Safety of SmartGrid equipment· Lightning strikes and ground potential rise· Lightning strikes and equipment failures

VP, Conferences Report: Q2-2010Doug Nix

As many of you know, Richard Georgerian hasbeen the VP, Conferences for PSES since theSociety’s inception in 2004. Richard was one ofthe key players in the EMC Society’s TC-8, theforerunner of the PSES and was instrumental inthe many events run by TC-8 and the PSES.

This year, Richard was forced to give up this im-portant role in the Society for work and family de-mands, and the Board asked me to step in for theremainder of Richard’s term. After organizing lastyear’s Symposium in Toronto, I couldn’t say no! Iam taking on this role with excitement, and alsowith a deep awareness of the shoes I need to fill.I look forward to working with everyone who hasbeen involved with our conferences over the years.

We had two main events planned for this year:Our first ever Summer Colloquium in conjunctionwith the EMC Society Symposium in Fort Lauder-dale, Florida in July, and our Annual IEEE Sym-posium on Product Compliance Engineering(ISPCE) in Boston this October.

Unfortunately, we were forced to cancel the Col-loquium due to a very low number of paper sub-missions. We did not feel that it would be reason-



able to charge a significant entry fee and then pro-vide only a very few presentations. Papers thatwere accepted for this event will be presented atthe Symposium this fall.

Our Symposium Steering Committee is going fullblast on the organization for this fall’s ISPCE. Theyhave chosen a great venue in the BurlingtonMarriott hotel in Burlington, MA, on the outskirtsof Boston.

We currently have more than 30 papers registeredwith more coming daily. We are anticipating pre-senting 48-55 papers, tutorials, workshops anddemonstrations this year. Deadlines for submis-sions of abstracts and drafts is midnight, 30 June,2010.

In addition, our exhibit area has grown, and therewill be more exhibitors and new vendors this yearthan ever before.

This coming year promises more challenges andmore opportunities for exciting growth in our So-ciety. Make this the year to get involved!

http://www.narte.org



MEDICAL ELECTRICAL SAFETY TESTINGUNDER ATTACK IN THE U.S.A.

by Greg Smith

You’re on the operating table, the surgery is almostover. The procedure has gone well. The doctors andnurses are walking in liquid on the floor covered withantiseptic, your blood, and other fluids. As your doctoris making the final repairs, a nurse is at the computertyping in some data; then she turns to assist the doctor,steadying herself with one hand on the computermonitor. As she touches the doctor, the faulty PC sendsits stray current through both of them and directly intoyour heart. They feel almost nothing, but you areespecially vulnerable, and in a few seconds, it’s toolate, the damage has been done.

How could this happen? Let’s examine the situationmore closely and try to determine what might have gone

as the only required evidence of product safety. (Thisis equivalent to the CE mark declaration of conformity).A national healthcare organization had worked hard tohave leakage current requirements stripped from NFPA99 (Standard for Health Care Facilities).

The hospital administration and the IT department hadforced purchasing to order regular consumer-typecomputers for the operating rooms (ORs). The ITdepartment had put a regular computer in a patient area,and the cord became pinched, causing the ground wireto contact a metal frame.

It’s possible there were people on consensus documentcommittees who allowed this to happen for “political”

Computers are everywhere in our healthcare facilities.

wrong. In this unfortunate scenario, a number of thingshappened because of what people and organizationsdid and did not do. A special interest group of foreigncomputer manufacturers had succeeded in pressuringthe Occupational Health and Safety Administration(OSHA) into accepting a “manufacturer’s declaration,”

or other unknown reasons. Some other people inhealthcare safety knew what was going on, but wereafraid to act against these organizations. So now, thehealthcare provider’s biomedical engineers were notallowed to test the computer. The doctors and nursesdid not even think to consider whether they might not



be safe to use in the OR environment. You had checkedinto the hospital not worrying about electrical safetyof the equipment. In this story, you are now a victim ofnegligence and careless tampering with safetyrequirements. Too late.

This article discusses safety issues surroundingelectrical equipment in U.S. medical applications fromthe perspectives of standards development, regulatoryagencies, and healthcare provider safety engineeringdepartments.

Can non-certified computers and equipment inhospitals kill patients?Product safety and biomedical engineering expertsknow the answer is “yes,” and so do designers andmanufacturers of safety-certified medical equipment.Many injuries and deaths have been caused by non-certified equipment, no matter the location or the typeof equipment. Computers are only one category. Whythen would an organization like the American Societyfor Healthcare Engineering (ASHE) attempt topotentially cripple U.S. safety standards and pressureThe Joint Commission (TJC) to have product safetytesting stopped? At the same time, when it comes tothe subject of inspection of equipment for U.S.certification and enforcement of existing laws, ASHEis silent. Why are ASHE and The Joint Commissionnot aggressively encouraging the proper testing anddeployment of computer equipment in hospitals underexisting regulations and safety standards?

The following is a quote from a letter written inFebruary 2009 by ASHE to TJC. “This is a rather timelysubject as ASHE is working hard to debunk a lot oflegend behind leakage current and with it remove itfrom NFPA 99…Our proposal has passed the publiccomment stage and has been accepted by the technicalcommittee. So we anticipate a significant reduction inrequirements for the 2010 NFPA 99 …and hope forelimination in the 2013 edition.” Clearly, this showsASHE’s intention to reduce the present level of safety.It’s important to consider that ASHE likely has noelectrical product safety professionals in their “workinggroups.” For now, the ASHE proposals have beenrejected, but it’s likely this issue will come up againsoon.

The Joint Commission, formerly The Joint Commissionon Accreditation of Healthcare Organizations(JCAHO), has also never taken a firm position oncertification and testing of medical equipment; instead,

relying on each organization to police itself and attemptto identify and maintain safety-certified equipment. Asearch of the JCAHO website(www.jointcommission.org) reveals that there are noreferences to safety of electrical equipment, ULstandards, certification or listing of equipment, orleakage current. Also, there is no mention of 29CFR1910 Subpart S, which requires all equipment in theworkplace to be listed or labeled by a NationallyRecognized Testing Laboratory (NRTL). The termlisted equipment means that equipment is certified bya U.S. NRTL for compliance with applicable standards,in this case Underwriters Laboratories standard UL60601.

If a piece of equipment is designed with impropergrounding or the grounding is compromised, there is apossibility of harm to high-risk and other patients.Normal use of portable, cord-connected equipment canlead to the risk of leakage current due to wear and tearon cords and plugs. Also, if a connection plug isincorrectly re-attached, exposure to leakage current mayresult. Such conditions and the resulting leakage currentcan cause cardiac arrest.

Studies on the effects of leakage current on humansshow that leakage current causes cardiac arrest incertain patients, especially high-risk patients. However,everyone involved with patients or present in these areasis exposed. For example, if a healthcare worker touchesa piece of equipment with higher-than-safe leakagecurrent and also touches the patient, both the patientand the healthcare worker will be put at risk. If a pieceof equipment is worn or damaged, the likelihood ofshock or energy hazard increases.1

Electrical safety standards for medical equipmentFor medical equipment, the primary U.S. standard formany years was UL 544, Safety of Medical and DentalEquipment.2 This standard requires that power suppliesbe certified as protecting any low-voltage outputcircuits, and often sets requirements for medical gradecords, plugs and other components. UL 544 was aconsensus product safety standard, and it was createdwith cooperation from product safety engineers, designand manufacturing specialists, medical/biomedical, andinspection authorities.

Products that met this necessarily strict standard becamethe best performers in healthcare in U.S. andinternational safety certification agencies. In the lastedition of UL 544, leakage current for ground-to-chassis



was limited to 300 Ã. Depending on the specificmedical device, leakage current limits in this standardare as low as 10 Ã. For example, a non-patient-connected device like a spirometer (connected to thepatient by a plastic air tube only) is required to have amaximum of 300 Ã leakage current from chassis toground. With an electrosurgical generator on the otherhand, the patient is in direct contact with appliedvoltage, so the limits are extremely low, in some casesas low as 10 Ã.3

UL 60601 is the “harmonized” U.S. version of aninternational standard, IEC 60601. The U.S. versioncontains national differences to account for differingvoltages and national regulatory requirements for theU.S. The leakage current limits and electrical safetyrequirements are very similar to the UL 544 limits. TheAssociation for the Advancement of MedicalInstrumentation (AAMI) standard,4 used by biomedicaltechnicians, is similar to IEC 60601, and requires achassis-to-ground maximum of 500 ̃ A. The advantageof harmonized standards is that they enable testinglaboratories to more readily certify products for bothU.S. and international requirements in a singleevaluation. Despite some differences, the requirementsfor leakage current are now similar worldwide. Anotherresult of this harmonization is that X-ray equipment,including portable X-ray units, is now subject to the60601 requirements. NFPA99 has similar testingrequirements and leakage current limits.5

Why is certain equipment not suitable for medicaluse?Why does medical equipment undergo different andmore rigorous evaluation and testing than othercategories of equipment, and why would unsuitableequipment be used in ORs, intensive care units (ICUs)and other patient care areas?

Medical grade equipment needs to be used in ORs,emergency rooms, ICUs, and all patient care and examrooms. For medical equipment, added safeguards andtesting are required. Listed medical equipment oftenhas special markings, such as “Do not use in thepresence of flammable anesthetics,” and “Groundingreliability can only be achieved with the use of ahospital grade receptacle.” When you see this kind ofequipment and hospital grade receptacles in the facility,then it is likely that the facility management hasrequired other equipment in these areas, such ascomputers, computer monitors, X-ray film viewers, etc.

to meet the requirements for medical use.6

Many pieces of equipment, such as microscopes orother laboratory equipment, regular “consumer”computers, office furnishings, or lights not listed formedical use, and many other products do not belong inthese areas.7 Still, there are many healthcare facilitiesthat have no incoming inspection for equipment, or noone on staff who would recognize a non-certified pieceof equipment. Many distributors do not even know thedifference; while some do know and try to pass off CEmarking as a certification mark. (CE is not acertification mark). Sometimes, physicians request verynew or prototype equipment directly from a distributoror manufacturer, thus bypassing any purchasingprocedures or incoming inspection by biomedicalengineering that might be in place. Much of this new/prototype equipment has never been tested for safety,and can put the physician and the healthcare providerin the unfortunate position of potentially harming thepatients they are trying to help.

In addition to more rigorous requirements for electricalsafety, NRTL-certified devices have to meetrequirements for electromagnetic interference andcompatibility (EMI/EMC). This means that thesedevices have to be designed and tested to receiveinterference from other devices without malfunctioning,and have to function without interfering with otherdevices. Equipment not certified for medical use maynot have to meet these requirements. Also, manydevices not certified for medical use do not meet therequirements for enclosure construction, and they canbe easily damaged by fluids commonly used inhealthcare facilities. This compromising of a devicewith fluid ingress can lead to short circuits and shock,even electrocution.

ExamplesThere are many examples of medical equipmentsuitable for use in patient areas. For instance, Cybernet(www.cybernetman.com) makes a medical gradecomputer, and Maxant Technologies(www.Maxant.com) manufactures medical displayworkstations and equipment for healthcare patient andoperating room environments. Both of these companieshave their products listed to UL 60601. Thesemanufacturers understand the certification requirementsfor products intended for use in healthcare facilities.

The following questions and answers are based on aninterview with Brud Sturgis, President of Maxant



Technologies.

Q. How does your experience and expertise differ froma computer manufacturer?

A. Unlike a manufacturer of general-purposecomputers, we work closely with medical end-users todefine use parameters and identify the proper productto meet specific needs. We have to understand in depththe nature of the healthcare delivery systems and howone modality differs from another. Our quality anddesign characteristics need to be of a higher standardin order to function in heavy use and lengthy periodsof 24/7 use. We need to have the ability to communicateeffectively with doctors and IT professionals to identifyneeds and configure the features of each product built.

Q. Are there companies selling non-medical gradeproduct into this market in competition with you?

A. Yes there are…however most of the major computermanufacturers are issuing disclaimers in their productliterature that their product does not and is not intendedto meet medical use standards in patient care areas.These disclaimers and warnings are most often ignoredin IT and purchasing decision making. Regardless, non-compliant equipment invariably finds its way intopatient care areas, thus putting patients at risk.

Q. How do you ensure regulatory compliance?

A. We had to develop in-depth knowledge of all relevantregulations and requirements, then design and buildunits which are capable of meeting or exceeding theseregulations. Every unit is tested prior to shipment toensure that all rules and regulations are met.

Q. How does the added requirement of meeting rulesand regulations (UL 60601 and others) affect costingand pricing decisions?

A. To navigate the quagmire of higher standardsrequired in hospital, we work closely with federallyapproved nationally recognized testing labs.Considerable added component costs andmanufacturing expenses are incurred to meet theserequirements. For example, we are required to acquireand maintain sophisticated testing equipment andestablish procedures to ensure that each product builtmeets all appropriate standards. Also, the quality andreliability of costly components must be ensured tomeet the demands of high-use healthcare environments.

All these factors add considerable expense to the costof goods sold, yet we still have to keep in mind severelylimited end-user budget requirements.

Federal Law (OSHA) 29CFR1910This law requires that all electrical equipment in theworkplace be listed or labeled by a nationallyrecognized testing laboratory. Some claim that it isOSHA’s responsibility to police safety in the workplace.Electrical safety groups such as the American Councilon Electrical Safety (ACES) have been working withOSHA to promote training of OSHA inspectors toenforce current laws, but it is an uphill battle for severalreasons. Due to budget and personnel limitations,OSHA most often visits a workplace after someone hasalready died. The fact that OSHA does such minimalenforcement leaves the workplace owner with heavyliability for injuries and deaths. When there areincidents of this nature, the workplace owner is forcedto bring lawsuits against equipment manufacturers anddistributors, and anyone else responsible for bringingor allowing this equipment in the workplace. This caninclude inspectors, contractors, hospital safetycommittees, risk management directors, and others.

FDA: problems and misconceptionsThe US Food and Drug Administration (FDA) is agovernment agency concerned with many issues andareas, most having no bearing on safety of equipment.Although there are FDA requirements for medicalequipment, these requirements are not generally relatedto electrical safety of this equipment, rather they focuson correct and reliable operation of equipment.

The FDA has an incident reporting database calledMAUDE. While this database is interesting, it has nosearch parameters for electrical injury and deathresulting from causes related to product safety.Additionally, this database is a voluntary reportingdatabase for incidents, relying on a variety of sources.Many of these sources are people who have no trainingin electrical safety and are not even minimally qualifiedto judge the root cause of an incident, much less todetermine if the incident was the result of leakagecurrent. In the end, this database is not a reliable sourcefor any scientific analysis of electrical injury or deathfrom equipment.

The FDA also ignores the matter of electrical safetycertification to U.S. standards. Perhaps this is becauseof the misconception that if a device functions correctly,it is thought to be electrically safe. Additionally, The



Project on Government Oversight reports that decisionsby senior FDA officials in 2006 eliminated criticalmeasures that keep manufacturers of medical devicescompliant with high quality standards.8

In a regulatory bulletin provided by Bureau Veritas, itwas revealed that under the provisions of legislationintroduced in 2009 in the U.S. House ofRepresentatives, manufacturers may face liability formedical devices that harm consumers, even if thosedevices received pre-market approval from the FDA.The proposed H.R. 1346: Medical Device Safety Actof 2009 would amend the Federal Food, Drug andCosmetic Act to provide legal recourse to patients whoare injured by a medical device that malfunctions.9

Why is the U.S. Congress considering a bill that wouldallow lawsuits against FDA-approved products? Mostlikely because FDA-approved products have injuredand killed, and the Supreme Court decision of 2008was a grave mistake. As many of us in product safetyare well aware, the FDA 510(k) Premarket approvalprocess is a flawed and highly questionable regulatoryrequirement. As more product recalls are being reportedby the media, Margaret Hamburg, the newly appointedFDA commissioner has said “there obviously have beensome problems” at the Center for Devices andRadiological Health, and has designated device reformas “a high priority” for the immediate future. FormerFDA Commissioner David Kessler described the devicecenter as “dysfunctional” and “in meltdown.”According to the new FDA chief, “Agency scientistshave said some devices that received 510(k) approvalshould have been required to show more data on safetyand efficacy.”10

In addition to these problems, the FDA has historicallyignored the requirements for electrical safety andfederal workplace law. Obviously the FDA in its currentstate is an unreliable source for research or meaningfuldata on the subject.

Healthcare provider technical staffHealthcare provider biomedical/clinical engineeringdepartments are a major force protecting our patientsand healthcare staff. These specially trained techniciansand engineering professionals work to ensure the safetyand proper operation of equipment for procedures andoperations. Their diligence and commitment to patientsafety is generally unseen and under-appreciated, justas is often the case with product safety certification

professionals.

Biomedical engineers and technicians performpreventive maintenance of portable equipment. Theseduties include repair and maintenance (cords, leads,equipment subject to abuse, and so on), and leakagecurrent, grounding and other tests, depending on theequipment being used. They also ensure equipment isoperating properly so that patients will not be put atrisk from faulty equipment. Grounding is the weak linkand doorway to leakage current injury. Regular testsare critical to ensuring these conditions do not puthealthcare workers and patients at risk. Frequency oftests required or recommended by product varies fromthree months to two years, depending on the type anduse of the equipment.

Recent reports from these departments indicate a trendtoward the use of regular, non-certified consumercomputer equipment in patient areas, but theirobjections tend to be ignored by hospital administrators.

Scott Trombley is a Certified Biomedical EquipmentTechnician (CBET) who has been working in this fieldfor over 25 years. He has worked with several hospitals,and is currently on the Agency for HealthcareAdministration’s (AHCA) expert list and was a speakerat the 23rd AHCA seminar. Scott and his employerInterMed work closely with the biomedical advisoryboard of Santa Fe College. He is currently vice presidentof InterMed Biomedical Services where he overseesoperations, employee safety and writes policyprocedures to comply with authorities havingjurisdiction (AHJs). These AHJs include The JointCommission, Agency for Healthcare Administration,and city and county electrical inspectors. Here Scottprovides answers for questions about leakage currentand other testing in healthcare facilities.

Q. Why are leakage current tests performed and howoften are they performed?

A. We perform electrical safety inspections (ESIs)routinely as part of an Equipment ManagementProgram. Whether it is on a scheduled device, loaner,rental, patient or physician owned, or post-repair, it iscommon that our technicians perform this test daily,along with other tests. Each day, equipment fails thesetests.

Q. What kind of test failures do biomedical technicians



see, and what are the causes?

A. There are various reasons for the excessive leakagecurrent: Degradation of components, which over timeshows up as a relation of leakage to wear when thepower supply or other components age or stress; abusedamage due to a variety of neglect or accidentsincluding missing or broken ground pins, spillage fromfluids that egress and evaporate leaving excessivecurrent leakage, and defective power cords; instanceswhere beds or other equipment may have damaged theconductors and cords. We see good systems connectedby bad or inappropriate power strips, and we seeinappropriate equipment for the patient care setting.All too often IT equipment intended for office orbusiness use finds its way into the clinical areas. Theseconditions can only be avoided by regular testing andinspection.

Q. Do hospital IT departments bring in equipment notsuitable for patient areas?

A. Unfortunately it is a common practice for doctors,purchasing agents, equipment representatives and ITdepartments to try to bring ordinary computerequipment into healthcare facilities and patient areas.Sometimes it’s merely due to lack of knowledge ofcodes and standards. Sometimes the equipment boughtin is certified, but not certified for patient area use—there is a big difference between medical devices andall other equipment. Since some of this non-certifiedand inappropriate equipment makes it into thesefacilities, we get a chance to inspect this equipment.What are the differences? Only an expert with the rightbackground and tools can answer that question. OSHAand many states realize this and this is why codes andlaws are in place.

Q. What about non-certified equipment?

A. The situation is the same with non-certifiedequipment. Most hospital administration departmentsand purchasing agents don’t know the inherent dangersassociated with unknown and untested devices. Thetypes of equipment vary from EEG devices to neuro-stimulation devices, computers, printers—the list isextensive. Many of these companies know better andcontinue to sell uncertified equipment. I can tell youthat most of the non-certified equipment I’ve seenrequired modification to be made safe. Grounding is abig problem in non-certified equipment, and grounding

problems lead to leakage current exposure.

Q. What is the perception of product safety in thehealthcare environment?

A. I live and work in Florida where state code requiresNRTL certification appropriate to the intended use.When we point this out, the responses I receive varyfrom concern for patients and staff to denial. Someworry about the legal aspects, others are genuinelyconcerned about compliance to state codes, but manyothers see no problems and will address problems IFthey occur. I hear a lot of comments such as,“Everybody else uses it,” or “We had one at the lasthospital I worked at, and our biomed there never saidanything.” Of course, there are also many who willhave any non-certified device inspected and tested; andalthough this can be a challenge, it is a wise and prudentchoice and the only way to really protect patients andhealthcare staff.

Deaths due to leakage currentMany deaths due to electrical shock and current haveoccurred since the widespread use of electricity. In the1960s, the issue of leakage current came to theforefront, resulting in the increased level of safety wenow have in place.11 There are many ways electricalshock can occur in a healthcare facility. Examples are:humidity in the plugs of blood and fluid heaters causingdevice failure,12 accidental toppling of a fluid containercausing spillage onto a blood pressure monitor,13

electric shocks to anaesthetists after touching a faultydevice and the chassis of another devicesimultaneously,14 an anaesthetised patient connectedto an ECG device that had been wired wrongly withthe earth and neutral connections transposed. 15

How widespread are cases of death by exposure toleakage current? This information is difficult to obtaindue to several factors: Patients simply die of “heartfailure” with no further detail provided. Many of thesepatients are high-risk, and are exposed to electricalequipment in regions of the country where hospitalsmay not have biomedical engineering departments andequipment. Many deaths go unreported or areincorrectly reported, but may actually be caused byleakage current.

U.S. NRTL product safety system, the CE mark, andSDoC proposalsA U.S. nationally recognized testing laboratory is a thirdparty agency which ensures that electrical products


meet a minimum level of safety. Conversely, supplierdeclaration of conformity (SDoC) and CE mark arenot product safety programs. A current issue of seriousconsequence for healthcare facilities (and alsoconsumers) is the repeated attempts by special interestdomestic and foreign computer manufacturing groupsto gain OSHA acceptance of SDoC. These specialinterest groups are again pressuring OSHA to allowthese products to be sold on the market as equivalentof a U.S. listed product (UL or equivalent).

SDoC is a self-declaration program similar to the CEmark self-declaration. This means that a company fromanywhere in the world can simply declare that theirproduct meets the international electrical safetystandards. In the testing laboratory business, we seethese self-declared products come in for evaluation andcertification for North America on a regular basis. Someof these products are so far away from being compliantthat they represent an immediate hazard, especially forfire and electric shock. Recently, the EU has consideredan additional product safety mark because of faulty,counterfeit and misrepresented products coming in fromAsia. For the U.S., this SDoC program would meanthat these cheaply made, non-tested products likecomputers will end up in our homes and in ourhealthcare facilities.16

Fortunately, we still have the OSHA federal law forthe workplace, 29CFR1910.303 and related sectionswhich requires all electrical equipment in the workplaceto be certified by an NRTL.17 Robert Stickels hasworked in electrical product safety for 20 years,including as a regulatory design engineer for NCR. Heis currently the director of field evaluations for TUVRheinland, and has personally inspected a great dealof medical equipment at numerous healthcare facilities.

Q. When you are inspecting a non-certified piece ofmedical equipment, do you find test failures for leakagecurrent? What kind of failures are you seeing?

A. Yes, I find test failures during leakage measurements.The equipment’s components may or may not becertified. Many times I find components are certifiedand when combined into the end-use product, theproduct as a whole does not meet the leakage currentrequirement set forth in the medical standard. I seemany failures between a few ˜A to 4 mA.

Q. What kind of equipment have you found these

failures in? Patient area? OR? Emergency?

A. This equipment is found in all areas. Case in point,Heart Cathlab A/V integrated system failed leakagecurrent tests. The problem was with power supplies.The power supplies were not rated for use with medicalequipment, instead they were certified/listed to the ITEstandard. A replacement power supply capable ofdelivering the current required by the monitor was notavailable. To fix the problem, a medical grade isolationtransformer was used to reduce the leakage current toacceptable levels. Other systems of concern are patientbeds, light fixtures, new types of procedure equipment,and others.

Q. What do the manufactures of this equipment sayabout these test failures?

A. Sometimes little or nothing; often the manufacturersimply states, “We have never run into this before,” or“The equipment meets the NRTL requirements for theintended use.” System integrators use what is costeffective and meets the immediate need. A/V equipmentdesigned for medical area use typically may not beavailable; therefore, testing and evaluation by an NRTLis necessary.

Q. What do the owners of the equipment say about thefailures? Did they know they were buying non-certifiedequipment?

A. It is buyer beware. Typically, the hospital and doctorsdo not have a clue; they only know what the equipmentdoes as far as the procedure it’s intended for. Theequipment is tagged for evaluation only whencompliance is required by a local AHJ, The JointCommission, state agency or an internal hospitalequipment acceptance procedure. Keep in mind thatnon-compliant equipment may range from as small asa relocatable power tap to OR equipment to equipmentas large as a DI water chiller system used for dialysispatients.

This fact remains: Equipment that is not suitablefor medical use can put patients and healthcareproviders at risk for electric shock and death. Tosuggest that critical testing, such as leakage current,should be stopped is like arguing that since cars haveairbags we can save money by removing seat belts.This is why the ASHE position on leakage currenttesting is especially troubling and dangerous. In theirproposal to cut sections of NFPA 99, the organization



states that these requirements are being cut in order to“…manage risks while bringing efficiencies to theregulatory compliance burden faced by healthcareproviders.” In other words, this is being done simply tocut costs. Any “re-engineering” of NFPA 99 shouldabsolutely consider the existing U.S. product safetystandards, (e.g., UL 60601) and their scientific basis.

As research has shown, ac leakage current can causecomplete cardiac arrest at low levels. When anelectrical product or system loses its ground, patientsand staff are immediately exposed to the possibility ofleakage current. Portable listed medical productsemploy heavy duty cords and plugs to help avoid theloss of ground; however, this condition is inevitable,especially when a piece of equipment is kept in servicefor many years.

Most people have a healthy fear of radiation, so no onequestions the physicist coming in to check equipmentthat uses radiation. Ironically, since our track recordwith electrical incidents and deaths has improvedbecause of the correct application of U.S. standardssuch as UL 60601 and NFPA 99, electricity has indeedbecome “invisible,” and because of this success thepractices of electrical safety are being questioned.

With counterfeit products from Asia, and specialinterests pushing things like the SDoC program, nowis the time for increased vigilance, not for softening orthe elimination of time-tested safety standards andproduct testing. The ASHE attempt to influence JCHAOand dilute NFPA 99 should be closely scrutinized andtheir vested interest and motivations identified andmonitored.

The laws of physics cannot be changed to suit aparticular purposeLives saved by accomplishments of product safety andhospital biomedical professionals are probably in thetens of thousands, and possibly more. The sciencebehind prevention of death from electricity has guidedthe requirements of national and international safetystandards. The history of electrical safety for medicalequipment is the history of the U.S. industry,engineering, government, and testing laboratoryprofessionals developing consensus safety standards.These requirements cannot be sacrificed to suit the plansof any special interest group. It’s a formula for disaster:Politics + Electricity = Death. Where electrical safetyis concerned it’s better to abandon politics and just dothe right thing. In the case of medical equipment and

electrical safety testing, we need to be allowed andencouraged to keep doing the right thing to protect ourfamilies, friends and communities.

Greg Smith, NCE is a Product Safety Engineer withMET Laboratories Southeast. He has personallyinspected and tested thousands of devices for METLaboratories (NRTL), and has visited hundreds ofhealthcare facilities in the course of electrical safetyevaluations. He can be contacted by e-mail [email protected] and by phone at 919-524-4555. This article is adapted from one published in theNovember-December 2009 issue of the IAEI(International Association of Electrical Inspectors)News.

References1 Swerdlow, C.D., and W. H. Olson, M. E. O’Connor,D. M. Gallik, R. A. Malkin, and M. Laks.“Cardiovascular Collapse Caused byElectrocardiographically Silent 60-Hz. IntracardiacLeakage Current: Implications for Electrical Safety,”Journal of the American Heart Association, (1999) 99:2559–2564.2 UL 544: Medical and Dental Equipment, 4th ed.,Underwriters Laboratories, Northbrook, IL, 1998.3 Eisner L, R. M. Brown, and D. Modi: “LeakageCurrent Standards Simplified,” Medical Device &Diagnostic Industry Regulatory Outlook, 2004.4 ANSI/AAMI ES60601-1:2005, Medical electricalequipment – Part 1: General requirements for basicsafety and essential performance, Association for theAdvancement of Medical Instrumentation, 2006.5 UL 60601-1, Medical Electrical Equipment, Part 1:General Requirements for Safety, UnderwritersLaboratories, Northbrook, IL, 2003.6 UL 1950, Safety of information technologyequipment, including electrical business equipment,2nd ed., Underwriters Laboratories, Northbrook, IL,1993.7 American National Standards Institute, ANSI C101-1992: American National Standard for Leakage Currentfor Appliances, Underwriters Laboratories, Northbrook,IL, 1992.8 “The FDA’s Deadly Gamble with the Safety ofMedical Devices,” Project on Government Oversight,February 19, 2009.9 S-540: Medical Device Safety Act of 2009, (HR 1346),111th Congress of the United States.10 Mundy, Alicia. “FDA Chief Eyes Device Group,”



Advantages of Membershipin the IEEE PSES

Makes you part of a community where you will:• Network with technical experts at local events and industry conferences.• Receive discounts on Society conferences and symposiums registration fees.• Participate in education and career development.• Address product safety engineering as an applied science.• Have access to a virtual community forum for safety engineers and technical professionals.• Promotion and coordination of Product Safety Engineering activities with multiple IEEE Societies.• Provide outreach to interested engineers, students and professionals.• Have access to Society Publications.

E-Mail List: http://www.ieee-pses.org/emc-pstc.htmlVirtual Community: http://www.ieeecommunities.org/emc-pstc

Symposium: http://www.ieee-pses.org/symposium/

Membership: The society ID for renewal or application is “043-0431”. Yearly society fee is US $35.

The Wall Street Journal, June 17, 2009.11 Bruner, J.M.R., MD. “Hazards of ElectricalApparatus,” Anesthesiology 28, March-April 1967:396-425.12 Linko, K. “Testing a New In-Line Blood Warmer,”Anesthesiology 52, 1980:445-456.13 Singleton, R. J., G. L. Ludbrook, R. K.Webb, and M.A. Fox. “Accidental Toppling of a Fluid ContainerCausing Spillage onto a Blood Pressure Monitor,”Anaesthesia and Intensive Care, 1993.14 Singleton, R. J., G. L. Ludbrook, R. K. Webb, and M.A. Fox. “Electric Shocks to Anaesthetists afterTouching a Faulty Device and the Chassis of AnotherDevice Simultaneously,” Anaesthesia and IntensiveCare, 1993.15 Atkin, D. H. and L. R. Orkin. “An anaesthetisedpatient was connected to an ECG device that had beenwired wrongly with the earth and neutral connectionstransposed,” Anaesthesiology, 1973.16 Federal Register (at www.osha.gov). For moreinformation on SDoC, go to www.osha.gov and type“SDoC” into the search box.17 Federal Register, 29CFR1910.303a and29CFR1910.399, Subpart S.



Richard Georgerianvoice: (303) 833-2327e-mail: [email protected]

People Looking To Start Chapters

Mike Cantwell, PESr. Account RepresentativeIntertek ETL SEMKO420 N. Dorothy Dr.Richardson, TX 75081Tel: 972-238-5591 x107Fax: 972-238-1860e-mail: [email protected] Paschetag [email protected]

Denver Colorodo Dallas Texas

Hiroshi [email protected]

Japan

Southern CaliforniaNorth Carolina

Charles [email protected]

Warren Fields

[email protected]

To see current chapter information please go to thechapter page at:

http://www.ieee-pses.org/Chapters/index.html

Chapter Safety Probes

China

Paul [email protected]

http://www.ieee-pses.org/Chapters/index.html



Portland SANTA CLARA

The Oregon/SW Washington Chapter reports thattheir speaker for their June 22 meeting was PetePerkins who discussed developments in standard60950.

For the summer, our Chapter will join the EMCSociety social event on a date a place yet de-cided.

The speaker for our September meeting will beJim Pierce who will discuss grounding issues.

Elections for Chapter Officers will occur at ourOctober meeting.

Future topics for October, November and beyondwill be in areas of CE Marking, Product Labeling,PV Safety, PV Grid Intertie, Batteries, HybridVehicles, and Forensics.

The PSES Winter Social will be in December(usually at Who Song & Larry's) to watch thelighted ships in the Columbia River.

IEEE PSES membership applications will alwaysnow be available at our meetings to encouragethe visitors to join and share in the benefits ofmembership.

On June 22, 2010 Meeting Topic was: Safety ofElectric Vehicle Charging Equipment

The bold new world of electric vehicles is uponus. You have probably seen advertisements bynow for a generation of all-electric vehicles com-ing to a showroom near you soon. SAE J 1772will be the configuration for virtually all productionelectric vehicles allowing North American EV driv-ers to plug into any manufacturer's EVSE (Elec-tric Vehicle Supply Equipment) and charge in astandards based environment. But what aboutthe safety of electric vehicle charging systems?In North America, EVSE is subjected to require-ments from the NEC, and UL standards. Thereare also IEC standards for electric vehicle charg-ers, but the connectors in Europe and the rest ofthe world have not been agreed upon. Find outwhat it takes to get an electric vehicle chargingstation certified and into the market place. Youwill learn what a 'CCID', '2nd neutral ground', 'level2', and other mysteries of the EVSE world..

Speaker: Gary Eldridge, P.E.

Gary Eldridge graduated from Sacramento StateUniversity with a BS in Electrical and ElectronicEngineering. Gary worked for Underwriters Labo-ratories from 1990 to 1997, and worked 2 yearsat Hewlett Packard. Gary also worked in the net-work industry for 2 years at Riverstone Networksbefore joining Apple Inc. where he worked for 5years. In April 2009 Gary joined start-up CoulombTechnologies. Gary has worked in safety, EMC,forensic engineering and fire investigation.

The Santa Clara Chapter meeting topic for Aprilwas "How to avoid becoming the next Toyota" andit was a joint meeting with the Reliability and EMCSociety local chapters. A panel discussion washeld. They also had a meeting in May and thetopic was "EU RoHS changes - What you need toknow." Visit the chapter website at:http://www.ewh.ieee.org/r6/scv/pses/index.html.

The Long Island Chapter meeting on Apr 20 wasa huge success. Co-sponsored by PES/IAS,approx. 50 attended and many received CEUcredit. The presentation slides, "Safety Aspectsof Power Distribution Engineering" are now avail-able on our IEEE PSES LI chapter website at:http://www.ieee.li/safety/index.htm.

LONG ISLAND



CHINA

Workshop Signals Increased Chinese Involve-ment in PSES

April 17, 2010 marked the first PSES seminar tobe held in China. The event was organized throughthe work of Paul Wang (G&M Compliance, IEEERegion 10 Director of Membership Development),CQC (China Quality Certification Center), andCQC-TS (test lab). More than 120 engineers at-tended the workshop, and seven topics were pre-

Chapter chair: Mr. Liu Yujun (CQC-TS)Vice chair for membership development: Mr.Limingming (CQC-TS)Secretary: Ms. Haolijuan (Certification Technologymagazine)Treasurer: Ms. Cathy Geng (G&M Compliance)

sented.

Paul Wang reports that preparations are underway to establish an IEEE PSES China chapter.The PSES bylaws for setting up chapters andchapter organization have been translated intoChinese, and a draft version of chapter regula-tions has been prepared in Chinese. The follow-ing individuals have been selected as candidates,with other positions yet to be confirmed:

Meanwhile, Mr. Mo Xiaofeng (CQC) is recruitingmembers from the CQC.

“Beautiful conference room, great food for breaksand luncheon, and the presentations were veryhigh quality,” comments PSES President MurlinMarks. “We will submit the chapter petition ASAP,”says Paul Wang.

From left to right: Mark Montrose (IEEE Division VI Cirector), Chen Wei (Vice President of CQC),Murlin Marks (President of PSES), Liu Fuguang (former Director of CQC-TS), and Thomas K. Ha

(Vice President of PSES).


Contact persons:Paul Wang ([email protected])Ivy Wu ([email protected])

Information for this article was provided by PaulWang.

Paul Wang receives volunteer certificate fromMurlin Marks.

Excellent facilities contributed to the successful meeting.



www.esafieldevaluation.caPhone: 1-800-559-5356 or 613-271-1489Fax: 1-800-559-5358 or [email protected]

Working with your every step of the way to ensure electrical equipment meets Electrical Safety Code requirements

Safety, Reliability and Peace of Mind You Can Trust

For scope of accreditation see www.esafieldevaluation.ca

http://www.esafieldevaluation.ca


Venue:�

Boston Marriott Burlington

One Burlington Mall Road

Burlington, MA 01803 USA

Phone:� 1-781-229-6565

Fax:� 1-781-229-7973

www.PSESSymposium.org

2010 IEEE Symposium on Product Compliance Engineering

Sponsored by the IEEE Product Safety Engineering Society

October 18 - October 20, 2010

Boston Massachusetts

Technical ProgramBob Griffin, [email protected] Tornquist, [email protected]

Conference Management/RegistrationChris Dyer, [email protected]

Call for Papers, Workshops, and Tutorials

The IEEE Product Safety Engineering Society seeks original, unpublished papers and tutorials on all aspects of product safety and compliance engineering including, but not limited to:

Product Specific: Medical, consumer, computer (IT), test and measurement, power supplies, telecommunication, industrial control, electric tools, home appliances, cellular and wireless, etc.

Hazard Specific: Electrical, mechanical, fire, thermal, chemical, optical, software, functional safety, control reliability, product reliability, risk assessment, etc.

EMC / RF: Electromagnetic emissions, electromagnetic immunity, regulatory, Introduction to EMC/RF for the safety and compliance engineer.

Components: Batteries, insulation, optocouplers, capacitors, transformers, current-limiters, fuses, lasers, ferrites, cables, connectors, electromagnetic suppression & protection, surge protectors, printed wiring boards, etc.

Certification: Product safety, electromagnetic emissions, electromagnetic immunity, environmental, processes, safety testing, regulatory, product liability, etc.

Standards Activities: Development, interpretations, status, interpretations, country requirements, Laboratory Accreditation, etc.

Research: Body physiological responses to various hazardous energy sources, unique safeguard schemes, electrically-caused fire, forensic methods, etc.

Environmental: RoHS, WEEE, EuP (Energy-using Products), Energy Star, Packaging Directives, REACH (Chemical), CeC, etc.

Demonstrations: Demonstrations of product safety testing techniques including mechanical, electrical, fire, etc.

Author’s ScheduleIntent to present and topic May 30, 2010Draft e-paper June 30, 2010Notification of Acceptance July 30, 2010Complete e-paper August 30, 2010

Prospective authors should submit e-papers using the on-line submission system accessible through the Symposium web site. Comprehensive submission instructions including paper templates are also available.


Past IEEE-PSES Symposium Records

CD Purchasing Information

SYMPOSIUM PAPERS ON CD:

The Product Safety Engineering Society continues to offer past symposium records for sale onCDs. The cost for the CD is $35 plus shipping and handling for IEEE members; $50 plus shippingand handling for non-IEEE members. At this time, check or money orders are the means for pay-ment. Please provide the following information:

CDs to be shipped to- ( Please print or type.)

Name:__________________________________________

Mailing address::__________________________________________

__________________________________________

__________________________________________

__________________________________________

IEEE member number:_________________

Shipping and handling: $5 per CD

Payment: Check or money order.

Make Check or money order to: "IEEE Product Safety Society"

Quantity: ____ x $35 = _________ for IEEE membersQuantity: ____ x $50 = _________ for non-IEEE membersSpecify what years you would like (2004 through 2008 are currently avalible):

__________________________________________

S&H: QTY_____ x $5 = _________

Total = _________Send payment to:

IEEE Product Safety Engineering Societyc/o Richard Georgerian, PSES Board of Directors7103 Sioux CourtLongmont, CO 80504U.S.A.

Depending on stock availability allow 2 to 3 weeks for delivery.



Our new members are located in the following countries: Australia, Austria, Belgium, Brazil,Canada, Chile, China, Costa Rica, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan,Kenya, Korea (South), Kuwait, Latvia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Portugal,Singapore, South Africa, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay,USA

New PSES Members from 29 March 2010 Through 16June 2010

Ahmad J SebzaliAhmed GamalAlan Warner

Alberto M Munante Aquije REPAlexander PeniazevAmir Geranmayeh

Andrea CozzaAndreas DoblanderAndrejs Romanovs

Andrew M TerryAndrew Otieno Nyawade

Angela P FerreiraAngelo BrunoAnindita MitraAnswer Sung

Antonio Moreno MunozAntonio Luis Flores-Galea

Anurasiri GamalathArgirios TzakasArthur D Beun

Arthur R TilfordAshok Golas

Banadr AbdullAllah AlqahtaniBernard C Fong

Bharatbhushan P JoshiBradley C Rowe

Brendan P BeahanBrian D OliverBrian E Bader

Brian R LamoureuxBruce Hanson

Byeong Kwon ParkByron Hamby

Carlos O MoralesCathy Geng

Chandru J MirchandaniCheng-Tsung Liu

Chia K ChaiChia-S Shih

Christopher E KasianChristopher J JohannChristopher J Murphy

CLAUDIU CADAR

Corey JasperCostas SinanasDale J Gutierrez

Dane E StoneDaniel Benta

Daniel D NaugleDavid A BrittonDavid C Cassano

David H GappDavid M MintzlaffDavid W Schreck

Dimitrios Parsinas PylorofDuarte P Goncalves

Fabio A VolonteriFelipe A Chacon-Vargas

Fernando Caballero-AfonsoFernando DevisFrancesco Muzi

Francisco Garcia-JuarezFrank Jenkins

Fred SongFrezier Anchia

Frieder EndrejatGary B JohnsonGee Keong Ong

Geoffrey A HofmannGeraldo P CaixetaGerardo H Paladini

Ghislain RemyGiovanni VarasanoGold Region Tran

Gonzalo MartinezGraham J Barraclough

Gregory D HartzoGregory F Dix

Haldor T HusbyHantian Gu

Hector A AvilaHiram Escabi

Holger RichterHulusi Karaca

HUNAIN DATTUIoannis John Melentis


Jack T RowleyJacob McEvoyJames A GuerryJames C SmithJan H Richter

Jan W VogelaarJared M GouldJean F Joubert

Jeffrey SchowalterJerry M Ricario

Jim KronrodJoe S Peeler

Johan M Van GrootelJohann Amsenga

John A KayJohn B Rose

Jonathan R HinkleJorge Bulcao

Jorge E Fernandez DaherJoseph WisnewskiJoseph A CrispinoJoseph A KerfootJosh S Zagorski

Judith E JohnsonKevin J Hight

King Wai LamKoen Meersman

LIJUAN HAOMahmood Tabaddor

Mark KeefeMd Ashraful IslamMehdi Farrokhrooz

Mehmet T SoylemezMelih Pazarci

Michael A RoyerMukhtar AhmadNallepilly V Mani

Nataniel R Da SilvaNathaniel Candelaria

R Lloyd A GorlingRammohan V MaikalaRathna Kumar DevarajRaymond A McCormick

Raymond J BishopRenzo Azaro

Rodney G ParkinRoy C J

Rudolf HaraksimSan Bun Chu

SATEESH MARAGANIScott Aldous

Shirley Cui-TarantinoSik Y Cheung

Srinivas GolakotiSylvain Demers

Teruo AzukizawaThomas J Bajzek

Thomas P ShefchickWade Anthony Munsch

Wei WeiWerner R DrexelWilliam L Brown

Yi Hong



The Product Safety Engineering Newsletter is published quarterly during the lastmonth of each calendar quarter. The following deadlines are necessary in orderto meet that schedule.

Closing dates for submitted articles:

1Q issue: February 12Q issue: May 13Q issue: August 14Q issue: November 1

Closing dates for news items:


Closing dates for advertising:


PSES Jobs Web Page

PSES has a page on our web site for employersand job seeks at http://www.ieee-pses.org/jobs.html. Employers may post jobs seeking regu-latory or compliance-related personnel free ofcharge. Job postings will remain on this web sitefor a period of 6 months but may be removed ear-lier by request of the employer.

Society members who are seeking jobs may list adescription of the position they are seeking freeof charge. A resume in PDF format may also beposted if desired. The listing will remain on thisweb site for 6 months, but the owner may submita request to renew the listing every six months,indefinitely. It may be removed earlier by request.

See http://www.ieee-pses.org/jobs.html for post-ing policy and how to submit requests.


Institutional Listings

We invite applications for Institutional Listings from firms interested in the product safety field.An Institutional Listing recognizes contributions to support publication of the IEEE ProductSafety Engineering Newsletter. To place ad with us, please contact Jim Bacher [email protected]

Tthe Product Safety Engineering Society will accept advertisements for employment and placelooking for work ads on our web page. Please contact Dan Roman for details [email protected] .

http://www.ieee-pses.org/jobs.html



The


Gary WeidnerGW Technical Services Inc.2175 Clarke DriveDubuque, IA 52001-4125

CHANGE SERVICE REQUESTED


The Product What’s Inside Safety - IEEE Entity Web Hosting · ing the VPs (Membership Services,...

Documents

Transcript of The Product What’s Inside Safety - IEEE Entity Web Hosting · ing the VPs (Membership Services,...