TABLE OF CONTENTS WELCOME MESSAGE 2 ISPCE 2019 … · Program and our Mentorship Program as well. interested in any of these technical activities? Please come. On Wednesday, we will

TABLE OF CONTENTS

WELCOME MESSAGE ............................................................................. 2 ISPCE 2019 SYMPOSIUM COMMITTEE ................................................. 3 PSES BOARD OF DIRECTORS .............................................................. 6 ISPCE 2019 GENERAL INFORMATION ................................................. 8

KEYNOTE SPEAKERS .......................................................................... 13 ISPCE 2019 PATRONS .......................................................................... 15 ISPCE 2019 EXHIBITORS ...................................................................... 16 SYMPOSIUM SCHEDULE - MONDAY .................................................. 30 SYMPOSIUM SCHEDULE - TUESDAY ................................................. 39 SYMPOSIUM SCHEDULE - WEDNESDAY ........................................... 47

CHAPTER OF THE YEAR....................................................................... 11

1

WELCOME MESSAGE

Once again, welcome to San Jose and Silicon Valley!

It’s our third year in Silicon Valley and the 16th ISPCE! This region continues to be a major source of global technical energy and development. Everyone at the conference should expect to have a fantastic experience that includes a stimulating program, networking with colleagues and even great food. The Double Tree by Hilton is a first class venue that can provide all the services our growing conference requires.

Many of you have attended past ISPCEs. We are doing our best to build on the highly regarded programs in past years. If this is your first ISPCE, welcome. I hope this is the start of a new tradition for you.

Our Technical Committee has put together another great program. The program covers topics ranging from Product Safety 101 to state of the art technical topics to the latest in global regulatory issues. You will surely find just what you need to address your current issues. And you’ll have the opportunity to learn something about technologies that will come in handy in the future. We want this to be a rich experience for you and a benefit to your company.

This conference is dedicated to engineers, administrators and managers who are charged with developing safe products that can be marketed in any location around the globe. Perhaps the most lasting impact of our conference is the opportunity to meet and develop relationships with other professional that will last through our careers. Technology and society are always changing, providing unlimited challenges. By working together through our IEEE society, we can optimize our professional experiences.

Welcome… Enjoy the conference!

Murlin Marks PSES Past President and ISPCE 2019 Chair

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ISPCE 2019 SYMPOSIUM COMMITTEE General Chair Murlin Marks, PSES, USA

Treasurer Lei Wang, Amazon, USA

PSES President John Allen, Product Safety Consulting

PSES President- ElectStefan Mozar, Dynexsys, Australia

Technical Program Co-Chairs Leszek Langiewicz, HP, USA Grant Schmidbauer, Nemko, USA

Technical Committee Secretary Mariel Acosta-Geraldino , IBM, USA

Track Chairs

Global Market Access Track Kimberly Adams, 7 Layers, USA

Compliance 101 Track John Allen, Product Safety Consulting, Inc, USA

EMC and Wireless Track Jim Bacher, IEEE, USA

Medical Track Rich Gardner, GE Healthcare, USA

Global Hazardous Locations Track Paul Kelly, UL, LLC, USA

Emerging Technologies Track Ted Eckert, Microsoft Corporation, USA

HBSE/Safety Science Track Tom Lanzisero, UL, LLC

Legal Track Susanne Wende, Noerr LLP, USA Ted Dorenkamp, Bowman and Brooke LLP, USA

Forensics Track Daren Slee, Exponent, USA

Environmental/Energy Track Bansi Patel, PSES, USA

Battery Track Jan Swart, Exponent, USA Rich Byczek, Intertek, USA

PSES VP CONFERENCES Professor Wen-Chung Kao

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Room Hosts

Monday John Allen, Product Saftety Consulting Inc, USA Daren Slee, Exponent, USA Maja Bland, Bureau Veritas, USA Ted Eckert, Microsoft, USA Bansi Patel, PSES, USA

Tuesday Paul Kelly, UL, LLC, USA Jim Bacher, IEEE, USA Maja Bland, Bureau Veritas, USA Ted Dorenkamp, Bowman and Brooke LLP, USA Susanne Wende, Noerr LLP, USA Jm Bacher, IEEE, USA

Wednesday Maja Bland, Bureau Veritas, USA Rich Byczek, Intertek, USA Rich Gardner, GE Healthcare, USA Bansi Patel, PSES, USA Grant Schmidbauer, Nemko USA, Inc., USA John Allen, Product Saftety Consulting Inc, USA Jim Bacher, IEEE, USA

Conference Management Conference Catalysts, LLC

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For more information on Global Hazardous Locations visit UL.com/HazLoc

For more information on EMC & Wireless Compliance, visit CTECH.UL.com

Minimize risk, maximize trust.

UL and the UL logo are trademarks of UL LLC © 2019

5

PSES BOARD OF DIRECTORS

Name John AllenStefan Mozar Mark Maynard Daniece Carpenter Murlin Marks Mike Nicholls Ken KapurSteli P. Loznen Professor Wen-Chung Kao Lei Wang

Executive Committee President President-Elect Past-President Secretary Treasurer Vice President - Communications Services Vice President – Membership Services Vice President - Technical Activities Vice President - Conferences Chapter Cordinator

Directors at Large Term Expires 12/19 Term Expires 12/20 Term Expires 12/21 Steve Brody Lei Wang V. JayaprakasanFabio Furlan Michael Anderson Steli P. LoznenDon Gies Daren Slee Catherine PellJeff Pasternak Bansi Patel Kim Fung Tsang

Vice President Communications - Mike Nicholls Committees Chairperson Newsletter Editor

Marketing Comittee Kim Fung Tsang

Mike Anderson Email List / EMC-PSTC Mike Nicholls

PSES IEEE Communities Dan Roman

Webmaster / Internet Mike Nicholls / Julia Iono v LinkedIn Admin Mike Nicholls / Mike Anderson

Vice President Member Services – Ken Kapur Committees Chairperson

Regions 1-6 coordinator Bansi Patel

Region 7 coordinator OPEN

Region 8 coordinator Steli Loznen

Region 9 coordinator Silvia Diaz Monnier

Region 10 coordinator Paul Kealey

Fellow Committee Sung-Jea Ko

Photographer Richard Georgerian

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Nemko Direct: International Market Access Program

Nemko makes sure that your product gets regulatory access to required markets fast and efficiently. With expert knowledge about rules and regulations worldwide, we avoid bureaucracy and give you access to the markets you want in the shortest possible time.

Nemko Service:

Pre-compliance

Safety Testing

EMC Testing

Telecom/Wireless Testing

CB Scheme Test Reports & Certificates

Multiple CountryCertifications andMarks

Why Use Nemko?

“One Stop Shopping”for All of your Testing

Quick TurnaroundTimes

Reduced Redundancyin Testing

Nemko is EU Notifiedand Competent Body

Contact us today!

Nemko San Diego 760-444-3500 Nemko Salt Lake 801-972-6157

Nemko US Mid West

214-563-6073 Nemko US East Coast 940-294-7057 Nemko Canada 613-737-9680

What is Nemko Direct? Nemko Direct undertakes the burden of application, necessary documentation, follow-up and communication needed to gain access to markets worldwide, especially in countries with complex product approvals. Nemko has bi-lateral agreements for acceptance of tests and inspections, which: minimizes time and cost avoids sending samples for retesting shortens lead times

WWW.NEMKO.COM

Indicates that the product is compliant with CE marking requirements for LVD as well as specific German requirements.

Indicates that the products are compliant with electrical safety requirements in USA and Canada.

Indicates that the products are compliant with CE marking requirements for up to 5 mandatory directives. LVD, EMCD, RoHS, ErP and R&TTE/RED).

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ISPCE 2019 GENERAL INFORMATION

Welcome Reception

Welcome to the 16th IEEE Symposium on Product Compliance Engineering. The Symposium Steering Committee invites attendees to join old friends and meet new acquaintances at the ISPCE 2019 Welcome Reception on Monday, May 6th, 6:00 PM – 7:30 PM. The Welcome Reception will be held in the exhibit hall and is included with your registration.

Exhibit Hours

Morning Lunch Afternoon Evening

Monday 8:00 AM – 9:20 AM

11:40 AM – 1:10 PM

3:20 PM – 3:50 PM

6:00 PM – 7:30 PM Reception

Tuesday 8:00 AM – 9:20 AM

11:50 AM – 1:10 PM

3:20 PM – 4:00 PM

*Exhibits will be closed during technical sessions

Registration Hours

Monday 7:00 AM – 6:00 PM Tuesday 7:00 AM – 5:00 PM Wednesday 7:00 AM – 4:00 PM

Best Paper Nominees

The Best Paper Award shines a light on some great papers. We are embarking on an initiative to increase the authorship of formal papers at the ISPCE symposium. We want the PSES to be the source that professionals go to first for critical information on product safety engineering and compliance issues. So, check out the Best Paper Nominees and think about a topic that could make you a winner!

Don Gies IEEE PSES Board of Governors

Best Paper Nominees are indicated with a gray background within the symposium grid

Special Meetings

Speaker Breakfast: On the day of your presentation, please join us for a special Speaker Breakfast in San Simeon. Breakfast will be available from 7:00 AM – 8:00 AM.

Exhibitor Breakfast: On each day of your exhibiting, please join us for a special Exhibitor Breakfast in San Simeon. The time for the breakfast is from 8:15 AM – 9:00 AM.

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Chapter Annual Meeting | Location: San Carlos: The CAM is set for Tuesday at 7pm. If you are a chapter leader – or would like to be one – please join us to share chapter ideas and issues. In the areas where we already have chapters, our members enjoy meeting regularly with fellow product safety and regulatory professionals. IEEE has tremendous resources to help chapters. Our society wants to help you access those resources to build a dynamic program for members.

Want to start a new PSES chapter? We can help guide you with that. As a professional society, we would like all our members to have access to regular chapter meetings. Come to the CAM and help us do it!

Lei WangPSES Chapter Coordinator

Technical Activities General Meeting | Location: San Juan: The Technical Activities General Meeting is set for Tuesday at 7pm. IEEE PSES Technical Committees are effective cross-industry tools to discuss and solve product safety issues and update global standards. We are moving forward with our Distinguished Lecturer Program and our Mentorship Program as well. interested in any of these technical activities? Please come.

On Wednesday, we will have our first Technical Committee Luncheon. We currently have four TCs: Forensic & Failure Analysis (Daren Slee, Chair); Telecom Safety (Don Gies); IT (Gary Schrempp) and Risk Analysis (open). Each TC will have a reserved table. There will be a sign-up near the PSES booth. Sign up early! Space will be limited to ten at each table.

If you are interested in becoming involved in any technical issue, let us know, and we can discuss how you might get involved. Take advantage of this useful, cross-industrial program that has been proven to be effective in changing global standards and educating participants on product safety matters. It is a great opportunity for your professional growth!

John AllenPSES President

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Congratulations!!!San Diego Chapter

Chapter of the Year 2018We are proud to announce that San Diego Chapter is the winner of the 2018 Chapter of the Year. In 2018, SD had ten meetings and one full day event, SSSD, which attracted 54 attendees. Their final 2018 meeting in December included a Holiday Dinner and End of the Year Celebration & Raffle. They added three new IEEE/PSES members. The 2018 SD officers were Leszek Langiewicz, chair; Byron Yakimow, treasurer; Gabriel Alcala, secretary; and Bansi Patel, membership development.

We would encourage all chapters to build their programs and PSES membership. You are the heart of our IEEE society. Let’s see what we can accomplish in 2019! The Chapter Annual Meeting is Tuesday, May 7 and will be hosted by our Chapter Coordinator, Lei Wang.

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CSA Ad

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KEYNOTE SPEAKERS

Monday May 6, 8:00 AM

Don Mays Chief Safety and Quality Officer Samsung Electronics America

Product Safety: Past, Present, and Future

Abstract

The keynote speech will cover what we have learned over the years that can help to inform our future product safety processes. It will discuss the culture of safety and how that has changed in big corporations, as well as the challenges and opportunities they will face in the future.

Bio

Don Mays is Chief Safety and Quality Officer at Samsung Electronics America where he has oversight of enterprise quality and product safety. He works to identify and mitigate product risks to Samsung, its customers, and consumers. Most recently Don was Managing Director at Deloitte where he led the firm’s product safety and quality advisory services.

Don was also the former Senior Director, Product Safety and Technical Policy for Consumer Reports. He directed his organization’s product safety program in its effort to reduce the number of unsafe products in the marketplace and help educate consumers about hidden safety hazards. Don also spent much of his career developing and operating laboratories for Consumer Reports, Intertek, and the Good Housekeeping Institute. Collectively, he brings more than 40 years of technical experience leading to a deep understanding of how companies can identify and mitigate their risks.

Tuesday May 7, 12:00 PM

Bill OrnerDirector of Systems Engineering

Bill Orner has more than 25 years’ experience in professional, consumer and industrial electronics specializing in systems-on-chip, system hardware design, system-on-package, low/ultra-low power electronics, electronic power management, firmware and control systems. Mr. Orner is currently the Director of Systems Engineering for a semiconductor company specializing in low power, high throughput programmable ML processors. Previously Mr. Orner worked at GoPro on the development of their GP1 custom image processing chip currently used in all their high-end battery cameras. He has also worked for MIPS, Philips, Transmeta, Portalplayer as well as several startup companies. Mr. Orner has a BSEET from Northeastern University and a MSTM from Pepperdine University. Mr. Orner is a member of SMPTE and a senior member of the IEEE, he is currently the secretary of the IEEE Consumer Electronics Society and also serves on standards committees for JEDEC and PCI-SIG.

Bio

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HP Inc. is a multinational information technology corporationheadquartered in Palo Alto, California, USA.

HP Inc. launched on November 1, 2015 as the successor of Hewlett-Packard, along with Hewlett Packard Enterprise. HP Inc. develops and provides personal computer and printer hardware. As a publicly listed Fortune 100 corporation, HP Inc. is a global leader in printing and personal systems; the company is focused on creating technology that makes life better for everyone, everywhere.

Backed by nearly 55,000 employees and drawing from a 80-year legacy of engineered innovation, the reinvented HP Inc. aims to create a world where technology works around the needs of society and adapts to every business and person, to their context and environment, helping them move from ideation to creation effortlessly and naturally.

Building on its market leadership in printing and PCs, HP Inc. makes it easier and more enjoyable for customers to print, as well as introduce personal systems that combine outstanding design and user experience with great value. HP Inc. will also pursue growth in adjacent markets, such as copiers, graphics printing and commercial mobility in key verticals. Finally, the company will define future market categories through its 3D printing and immersive computing platforms that fuse together the physical and digital worlds.

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ISPCE 2019 PATRONS

Platinum Patrons

Gold Patrons

Media Patron

Speaker Gift Patron

Lanyard Patron

Reception Patron

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ISPCE 2019 EXHIBITORS

Advanced Test Equipment Rental Advanced Test Equipment Rentals (ATEC) is a global leader in renting compliance and pre-compliance test and measurement equipment for meeting multiple international standards; including IEC 61000, DO-160 and Mil-STD-461G CS 118. ATEC offers short and long term rentals of ESD guns, amplifiers, transient generators, power supplies, loads and more. ATEC carries over 5000 different products, and has a large inventory of test equipment from popular manufacturers like: AMETEK (EM Test, IFI, MILMEGA, Teseq), Amplifier Research, Associated Research, Chroma, EMC Partner, Haefely Hipotronics, Montena, and many others. Since 1981, ATEC has continued to serve customers by providing the equipment they need from an experienced staff they can trust. Rent or purchase equipment today at www.atecorp.com.

AMETEK CTS US is the leading manufacturer of test and measurement instrumentation for electromagnetic compatibility (EMC) testing, with manufacturing sites in Switzerland, Germany, the United Kingdom, and USA, producing a broad range of conducted and radiated EMC compliance testing systems and RF amplifiers. It consists of the Teseq, EM Test, IFI and Milmega brands.

Ametek CTS US

Bureau Veritas Consumer Products ServicesBureau Veritas is a global leader in testing, inspection and certification (TIC) services. We help businesses improve safety, sustainability and productivity; and our clients include the majority of leading brands in consumer and technology product industries from retailer to brand and manufacturer to supplier. With a presence throughout the USA and in every major country around the world, our quality assurance and compliance solutions are vital in helping our customers enhance product quality and concept-to-consumer journeys. We also assist with increasing speed to market, profitability and brand equity throughout the supply chain. Bureau Veritas is a leading electrical/electronics, automotive and wireless/IoT testing, inspection, audit and certification provider. Our global network of test laboratories supports the technology products industry in areas of quality, health & safety, environmental/chemical and social requirements as well as connectivity, security and interoperability.

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http://www.atecorp.com/

ED&D is your One-Stop Shop for Product Safety Test Equipment, offering the world's most extensive inventory available. Everything you need for Product Safety testing, such as Automated Hipot testers, digital leakage current testers, Impact hammers, glow wire testers, IP Code Equipment such as Dust chambers, jet nozzles, Drip Boxes, waterproof turntables, probes, force gauges, and many more items, of which many will be on display. ED&D is ISO 17025 Accredited, with the industry's most complete Scope for specialized test equipment. Product Safety Training courses also available.

CSA Group is a global testing, inspection, certification, and standards development organization, dedicated to safety, social good, and sustainability. With a century of experience, we strive to help organizations bring their products to markets around the world fast and efficiently by navigating global regulatory landscapes. The key to our exceptional customer service is simplifying the complexity of product testing and certification through our network of state-of-art labs and team of technical experts, serving key industries such as healthcare, home & commercial, industrial & hazardous locations, and specialized technologies. Our mandate is to hold the future to a higher standard.

CSA Group

Compliance West Compliance West has been providing safe and reliable safety specific testers worldwide since 1997. We are the leading provider of surge testers, hipot testers, capacitive discharge testers and other specialized testers to assist the product safety professional. In addition to our catalog testers, we offer custom solutions for laboratory and production tests to customers worldwide. For this year’s ISPCE show, we are proud to present our new 300A Ground Bond Tester, our new medical surge tester which mimics the output of the HP Codemaster Defibrillation Tester, and our LCB Line of IEC 60990 Compliant Touch Current Networks. Please visit us IRL at ISPCE 2019, and anytime at www.compwest.com. We’re looking forward to showing you what’s new.

ED&D

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Compliance DynamicsCompliance Dynamics services and supports diverse leading-edge technology companies with their Business Management System, Operational and Regulatory Compliance needs. We are focused on delivering significant benefits to our customers by increasing product revenue, reducing time to market, decreasing product cost while decreasing product development costs.Our products and services include;• Pre-Compliance - Saving our customers valuable time and money by involving Compliance Dynamics early in the product development process;• Compliance – Transition directly into the approval process through our partnership with Nemko;• Product Lifecycle Management – Preconfigured PLM software solution which effectively and efficiently supports managing the product design intent while also addressing quality and product regulatory compliance requirements.Please visit our website: www.mycdyn.com, or contact us at [email protected]

Eurofins | MET Labs Eurofins | MET Labs is a service leader and trusted provider of product testing and regulatory certification of electrical products for leading brands and companies in the United States, Europe and worldwide. In 1989, MET broke the UL monopoly for product safety testing and certification in the United States and is approved to certify products in over 200 UL standard categories. In 2018, MET joined the Eurofins Scientific network and has become a key component in Eurofins’ product testing portfolio of 650 laboratories worldwide.

Energy Assurance LLC is a fully accredited laboratory specializing in the regulatory and performance testing of small and mid-format cells and battery packs. Established in 2009, Energy Assurance is located just outside of Atlanta, Georgia and is jointly owned by Cindy Millsaps (President/CEO) and John Copeland (Vice President/COO). Combined, they have over 40 years of experience in the portable energy arena. Energy Assurance’s independent accreditations include: ISO 17025 through ANAB covering a multitude of cell and battery test standards; UL Certificated Agent and Data Acceptance Program lab (Third Party Test Data Program); TÜV-SÜD Certification and Recognition of Agents Testing (CARAT) lab; and IECEE Certified Body Testing Laboratory (CBTL) for the product category BATT.

Energy Assurance LLC

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EMC Society The IEEE Electromagnetic Compatibility Society is the world's largest organization dedicated to the development and distribution of information, tools and techniques for

17reducing electromagnetic interference.

ElementElement specializes in providing a comprehensive range of materials and product qualification testing, consulting, and certification services. Our network includes 6,700 Engaged Experts operating out of 188 facilities in more than 30 countries across multiple industry sectors. Service offering includes EMC, Wireless, Product Safety Testing and Certification. With an extensive roster of accreditations and international recognitions coupled with unparalleled service and facilities, Element is your testing partner for both materials and product qualification testing.

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http://www.productsafet.com/

http://www.emtlabs.com/

InCompliance Magazine In Compliance delivers coverage on the latest standards updates, global compliance news, and engineering developments as well as technical explanations &

guidance to over 17,000 electrical engineering professionals worldwide. Discover the latest design practices and testing tips, stay current with important updates, learn fundamental concepts, explore current events, & more! Visit incompliancemag.com to start exploring and to activate your free subscription.

Ikonix USA Ikonix USA consists of the leading global brands, Associated Research, SCI, and Associated Power Technologies. We provide test and measurement products and educational services to manufacturers around the globe. Ikonix USA helps manufacturers keep their employees and customers safe from the dangers of electricity. Stop by to talk safety with our Application Engineers.

HAEFELY HipotronicsAt HAEFELY HIPOTRONICS we believe in providing high quality test equipment to meet the world’s reliability and compliance needs. With a focus on transient immunity testing, our global customers have access to safe and reliable solutions that cover a variety of international standards including the IEC 61000-4-X series. HAEFELY HIPOTRONICS, as a subsidiary of Hubbell Incorporated (HUBB), employs over 260 people worldwide and hold numerous U.S. and international patents. With production areas in both the United States and Switzerland, we bring 110 years of combined history and experience to our work focusing on total quality.

HV Technologies Inc. Supplier of high quality test equipment from independent, creative, customer-centric partners.

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Nemko

Nemko is your complete source for compliance testing, certification and worldwide market access. Nemko provides one local point of contact for all major market certifications using our Nemko Direct network. Nemko offers EMC/RF/Wireless and Electrical Safety testing and certification. Our experienced engineers make available “pre-compliance” evaluations to reduce the time to market. We issue certifications for more than 150 countries with Nemko Direct for Telecom and North American, NRTL and Canada, Safety Certification. Nemko also delivers CB Scheme International Certifications for more than 40 countries. With over 20 locations globally and an experienced international staff, Nemko is strategically positioned to provide on time certifications and approval support

iPoint

iPoint is a leading provider of software and consulting for environmental and social product compliance, and sustainability. Thousands of companies around the globe rely on iPoint solutions and services for managing, tracking, analyzing, and reporting data across their value creation network.iPoint consulting and supplier management services supports clients in staying ahead of global regulations and requirements including Materials Compliance (REACH/RoHS/Prop 65), Conflict Minerals, and other emerging global developments in the arena of social product compliance such as Anti-Human Trafficking.iPoint is located in Ann Arbor Michigan and is a wholly owned subsidiary of iPoint-Systems gmbh. iPoint-Systems is headquartered in Reutlingen Germany and has 180 employees operating out of 11 offices worldwide.

Intertek Intertek is a global leader in testing, inspection and certification services, which operates in over 1000 laboratories and offices in 100 countries throughout the world. Intertek provides Global Market Access through its local services, including EMC testing, energy efficiency testing, environmental testing, calibration, product safety testing, certification and performance testing for clients in such industries as appliances, military, HVAC, components, industrial, medical, telecommunications, lighting, automotive, semiconductor, retail, building products, telecom, wireless, and cabling products. For more information, visit www.intertek.com.

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http://www.metlabs.com/

http://www.nemko.com/

TUV Rheinland

TÜV Rheinland, www.tuv.com/us, is a leading international provider of product testing and certification services for all product types. This includes testing to the Low Voltage Directive, CB Scheme and CE Mark; EMC/ EMI testing; solutions for WiFi®, Bluetooth and ZigBee®,and cybersecurity and risk management for medical devices. Evaluated products range from household appliances to wearable devices and 3D printers. Assistance with European environmental directives and international approvals programs complete TÜV Rheinland’s comprehensive service portfolio.

ORBIS Compliance LLC ORBIS Compliance is a strategic partner to manufacturers around the world looking for in-depth regulatory knowledge, and dependable and reliable execution of their product compliance strategy for Latin America and Asia.

ORBIS is industry-recognized for being able to “Solve the problems that others can’t.” ORBIS’ engineering and legal experts have in-depth, technical and regulatory knowledge in the telecom, safety, energy efficiency, battery, medical and environmental fields. The hallmark of our culture is accurate execution and accelerated in- country testing and product certifications in the Latin American, Caribbean and Asian regions. Our time-to-market strategy is fast, and attributed to our direct relationships with regulatory agencies. ORBIS’ mission is driven by our clients’ need to succeed with their regulatory needs.

OnRule OnRule is a world-leading cloud-based software platform to manage product regulatory compliance. OnRule enables enterprises to rapidly launch new products in the global marketplace by accelerating the product certification process, streamlining collaboration, and delivering up-to-date global regulatory intelligence. OnRule organizes the compliance records by products, markets, record types, and record disciplines. It creates SmartCerts™ enabling a quick search and secured sharing; the view-only privileges allow the internal and external stakeholders to have visibility on the compliance status and records. The notifications of upcoming expirations alert the compliance team, prevent stop ship and ship hold; and enable proactive budgeting and allocation of resources. The Standards Update Notifications inform the enterprises of upcoming changes in the standards and identify the impacted products and records portfolio.

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http://www.tuv.com/us

UL As a global company with more than 120 years of expertise, UL works with customers and stakeholders to help them navigate market complexity. UL brings clarity and empowers trust to support the responsible development, production, marketing and purchase of the goods, solutions, and innovations of today and tomorrow. We connect people to safer, more secure, more sustainable products, services, experiences and environments – enabling smarter choices and better lives. For more information visit www.ul.com

VitrekVitrek is the leading manufacturer of High Voltage Test and Measurement equipment. Vitrek products are used by national testing labs, R & D departments and engineering labs in a variety of industries including compliance testing, photovoltaic, medical equipment, power conversion, electrical component and appliance manufacturing. Our products include Hipot & Ground Bond Testers, Power Analyzers, High Voltage Measurement and High Voltage Switching. Vitrek’s recent acquisition of the XiTRON brand of high performance instruments expands the company’s portfolio to include portable calibrators for thermocouple and millivolt DC calibration, ballast testers, LED illumination spectral analyzers, programmable DC electronic loads, phase-angle voltmeters and digital milliohmmeters.

TÜV SÜD America

TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions. Over the last 150 years, we have added value to our partners and customers through a comprehensive portfolio of testing, certification, auditing and advisory services. We have enabled progress in society and businesses by staying true to our purpose of protecting people, the environment and assets from technology-related risks.

Today, we are represented by more than 24,000 employees located across over 1,000 locations. Our community of experts is passionate about technology and is inspired by the possibilities of your business. United by the belief that technology should better people’s lives, we work alongside our customers to anticipate and capitalize on technological developments.

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Oracle Ad

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7:00 AM - 6:00 PM Registration – Donner/Siskiyou/Cascade Foyer 7:00 AM - 8:00 AM Speaker Breakfast – San Carlos 7:30 AM - 8:00 AM Continental Breakfast & Exhibits – Donner/Siskiyou/Cascade Ballroom 8:15 AM - 9:00 AM Exhibitor Breakfast – San Carlos 8:00 AM - 9:00 AM Keynote Speaker – Don Mays – Donner/Siskiyou/Cascade Ballroom

9:00 AM – 9:30 AM Coffee Break & Exhibits – Donner/Siskiyou/Cascade Ballroom Rooms San Carlos San Juan San Martin San Simeon

9:30 AM - 10:30 AM

Compliance 101: Origins and Basics of Electrical Fire and

Shock Protection

Mike Sherman

**Arson Under The Christmas Tree - a forensic

evidence case study

Louis Bilancia

Global Market Access Regulatory Changes in China –

2018

Vanessa Wen

**Dalziel revisited; Electric shock analysis of

mixed bipolar and monopolar waveforms

Pete Perkins 10:30 AM - 10:40 AM Transition/Networking

10:40 AM - 11:40 AM

Compliance 101: Electric Shock, Touch Current

Peter Perkins

Understanding and Investigating Burn Injury

Kenneth Lee

Korea Market Access for Electrical and Electronic

Equipment Michael Cheng

**Experiments of DC Human Body Resistance II: Test

Results and Analysis of Data from Fifty-Two People

Hai Jiang

11:40 AM - 1:10 PM Lunch & Exhibits – Donner/Siskiyou/Cascade Ballroom

1:10 PM - 2:10 PM

Compliance 101: Applying Toy Safety Standards To Your

Consumer Electronics Product

Dan Roman

69 kV Sub-Transmission Line, a Careless Painter and a Scissor Lift - A Potential

Electrical Hazard

Nosh Medora & Ashish Arora

Realization and maintenance of a regulatory compliance;the devils in the details, yet the

details are overwhelming! What to do?

Roger Martin

**Safety of Free-Space Optical Communication System

Done Gies

2:10 PM - 2:20 PM Transition/Networking24

Rooms San Carlos San Juan San Martin San Simeon

2:20 PM - 3:20 PM

Compliance 101: Consumer Electronics - Basic Product

Safety

Julio Posse

**Illumination Caused Permanent Bodily Injury,

Photons Not Taken Lightly

Louis Bilancia

Market access for wireless products in Europe and

South America

Pollux Sanchez

The Need for a New (or Redefined) Discipline: Product

Health and Environmental Safety Engineering

Michael Kirschner

3:20 PM - 3:50 PM Coffee Break & Exhibits – Donner/Siskiyou/Cascade Ballroom

3:50 PM - 4:50 PM

Navigating the Product Safety Certification Cycle: Using Early

Engagement and Best Practices to minimize Project

Risk

Christopher Kincaid

Tin whiskers and automotive electronics

Kuykendal & Kingsley

Beyond the basics: Save the trauma for when it really counts

Lars Mellanders

Key Considerations and Challenges with IEC 62368-1

Leszek Langiewicz

4:50 PM - 5:00 PM Transition/Networking

5:00 PM - 6:00 PM

Compliance 101: Managing Product Safety Knowledge

Mike Sherman

Product Designing for a Circular Economy

David Linder

Going Global: Wireless Handbook for helping

manufacturers bring wireless devices to the global market

Theresa Glenna

Panel discussion 62368-1

6:00 PM - 7:30 PM Exhibitor Reception – Donner/Siskiyou/Cascade Ballroom

**Peer-Reviewed Paper Best Paper Award Nominees are shaded25

7:00 AM - 5:00 PM Registration – Donner/Siskiyou/Cascade Ballroom Foyer 7:00 AM - 8:00 AM Speaker Breakfast – San Carlos 7:30 AM - 8:00 AM Continental Breakfast & Exhibits – Donner/Siskiyou/Cascade Ballroom 8:15 AM - 9:00 AM Exhibitor Breakfast – San Carlos 8:00 AM - 9:00 AM Plenary – Donner/Siskiyou/Cascade Ballroom 9:00 AM - 9:10 AM Transition/Networking


9:10 AM - 10:10 AM An Introduction to

Hazardous Locations - Basics and Protection

Concepts

William Fiske

Overview of RF Exposure Requirements

Grace Lin

Brazil Spotlight - INMETRO Safety for ITE, HOUS, MED and

Ex, Anatel for Wireless and Energy Efficiency

Theresa Glenna

Practical Methods for Establishing a Product Safety

Program

Don Mays and Mike Gentine

10:10 AM - 10:50 AM Awards Ceremony, Coffee Break & Exhibits- Donner/Siskiyou/Cascade Ballroom

10:50 AM - 11:50 AM

Creating HazLoc Product and Compliance

Guidelines for the Marijuana Industry

Linn Haverlick

Part 1 of 3: Introduction to EMC Compliance- Printed Circuit Board and System

Design

Mark Montrose

What in the World? A update on the latest international

requirements (EMC/Safety)

Lars Melladers

Regulatory Update for the US and the EU: Legal

requirements for distributing products online; current

market surveillance programs; new developments with regard to environmental product law

(WEEE-Directive) Mike Gentine (CPSC) and Susanne Wende

(EU)

**Peer-Reviewed Paper 26

11:50 AM - 1:10 PM Lunch & Exhibits& Keynote Bill Orsen– Donner/Siskiyou/Cascade Ballroom Rooms San Carlos San Juan San Martin San Simeon

1:10 PM - 2:10 PM

Training on the Oil & Gas Industry - Upstream /

Midstream / Downstream

John Chambers

Part 2 of 3:Introduction to EMC Compliance- Printed Circuit Board

and System Design

Mark Montrose

Optimizing supply chain communication with respect to

requiremnts under RoHS, REACH

Eva Hink

Legal Implications for Product Distribution after Brexit

Susanne Wende

2:10 PM – 2:20 PM Transition/Networking

2:20 PM - 3:20 PM OSHA's Nationally Recognized Testing Laboratory Program -

On the Verge of Change

Kevin Robinson

Part 3 of 3:Introduction to EMC Compliance- Printed Circuit Board

and System Design

Mark Montrose

BRIC Product Compliance (Brazil, Russia, India, & China)

Mark Maynard

Using Product Testing in Litigation

John Loud and Ted Dorenkamp

3:20 PM - 3:50 PM Coffee Break & Exhibits – Donner/Siskiyou/Cascade Ballroom

4:00 PM - 5:00 PM

The Evolving Landscape for Global Hazardous Locations - Considerations for Equipment

Certification Christopher Kincaid

Bluetooth Certification

Tom Tidwell

New regulations of China CCC, SRRC and NAL

Paul Wang

Post-Sale Duties and Defending Post-Recall Lawsuits

Ted Dorenkamp

5:00 PM - 6:00 PM Unmanned Robots and Drones in Global Hazardous Locations

Paul Kellyr

Citizen's Broadband Radio Services and OnGo Certification.

Tom Tidwell

Latest Country Regulatory Update

Tina Ding

POWER SUPPLY SAFETY

Gary Tornquist

6:00 PM – 7:00 PM Monta Vista Robotics Team Demonstration - Donner/Siskiyou/Cascade Ballroom 7:00 PM – 8:30 PM Chapter Annual Meeting – San Carlos Ballroom 7:00 PM – 8:00 PM Technical Activities Meeting – San Martin

**Peer-Reviewed Paper 27


7:00 AM - 4:00 PM Registration – Donner/Siskiyou/Cascade Ballroom Foyer 7:00 AM - 8:00 AM Speaker Breakfast – San Juan 7:30 AM - 8:00 AM Continental Breakfast & Networking- Siskiyou Ballroom

8:00 AM - 9:00 AM

India TEC (Telecommunication Engineering Center)

Lars Melladers

The Heated Needle Penetration Method for Li-ion Thermal

Runaway Initiation

Dustin Summy

Security Risk Management for IoT Devices - Standards, Methods, and Insights

Laura Elan

Material and Substance Requirements for EEE, Conventions, Treaties,

Surveillance, REACh and, of course, RoHS David Linder

9:00 AM - 9:10 AM Transition/Networking

9:10 AM - 10:10 AM

Telecom Regulatory Updates Affecting 2019

Approvals in Latin America

Elizabeth Perrier

The Overlooked Critical Factor - 5 questions to ask whendesigning your battery-

operated product Rodney Grimes

**Topological Vocabulary for Supporting Conformity

Assessment of Interoperable Medical Products;

Challenges and Directions for Life-Cycle Processes

John Hatcliff

**(I'm) Perfectly Safe

Dan Roman

10:10 AM – 10:20 AM Transition/Networking

10:20 AM - 11:20 AM

Application of Blockchain Technology to Laboratory

Operations

Leslie Bai

Testing Tools and Methodologies for Lithium-ion

Cell Qualification

Keith Beers

Current Trends in Electromedical Equipment

Standards

Naysahn Saeed

Alternate Low Power Modes

Ted Eckert

**Peer-Reviewed Paper

28

11:20 AM - 12:20 PM Lunch – Siskiyou Ballroom Rooms San Carlos San Juan San Martin San Simeon

12:20 PM – 1:20 PM

**Compliance 101: Product Markings and Labels

Rich Nute

Applying Functional Safety in the Battery System for Electric

and Autonomous Vehicles

Yike Hu

IEC 60601-1-12 Emergency Medical Services Standard

(EMS) and Essential Performance

Richard Gardner

EU REACH update

Michael Kirschner 1:20 PM – 1:30 PM Transition/Networking

1:30 PM - 2:30 PM

Compliance 101: Risk Assessment for LVD and

EMC Directives

Patty Knudsen

UN 38.3 Lithium Battery Transport Testing – Overview

& Updates

John Copeland

EU MDR Hazardous Substances in Medical Devices

Geoffrey Bock

International Standards - used for EV supply equipment for

charging electric road vehicles

Tina Ding

2:30 PM – 2:45 PM Transition/Networking/Coffee Break

2:45 PM - 3:45 PM

My experience of Product Compliance - Motivation to

change IEC standards

Hiroshi Sasaki

Global Regulatory Updates for Small Format Lithium-Ion

Batteries and Power Banks

John Copeland

Middle East Countries Electronic Product Compliance

Mark Maynard

Regulatory Updates E-Waste and Take Back Laws in Latin

America.

Elizabeth Perrier

2:45 PM - 3:45 PM Transition/Networking

3:55 PM - 4:55 PM

**Compliance 101: Safe Design of Laser Consumer

Products Erwin K Lau

Don't Let Global Regulatory Compliance Negatively Impact

Your Product's Reach Catherine Wong

Assessment of a product to determine safe Electromagnetic

Field (EMF) Exposure levels Tom Tidwell

EU RoHS 3: Are You Ready?

Kenneth Stanvick

5:00 PM - 5:30 PM Closing Session and Wrap-Up – Siskiyou Ballroom **Peer-Reviewed Paper

Best Paper Award Nominees are shaded 29

ABSTRACTS

MONDAY, MAY 6, 2019

Time: 9:30 - 10:30 AM Room: San Carlos Ballroom

Arson Under The Christmas Tree - a forensic evidence case study Louis Bilancia (Engineering Systems, Inc., USA) Dale Mann (Engineering Systems, Inc., USA)

Abstract: A quaint rural mountain cottage fire was initially ruled as an accidental Christmas tree fire. The insurance company Special Investigation Unit (SIU) discovered information that prompted further fire scene investigation. The scene investigation resulted in evidence that the fire was likely intentionally set. The site inspection posed a number of challenges including schedule delays, inclement weather, an unusual ignition source, multiple potential first-fuels, and last-minute revelations during trial preparation. The investigation included chemical analysis, photograph meta-data examination, simulations, and a series of full-scale, fully instrumented test burns, topped off with an out-of-the-ordinary legal strategy. This paper reviews the investigation, tangible evidence, scientific analyses, and expert testimony that supported the insurer's decision to deny the claim and the jury's agreement with that decision.

Time: 9:30 - 10:30 AM Room: San Juan

Compliance 101: Origins and Basics of Electrical Fire and Shock Protection Mike Sherman (Graco Inc., USA)

Abstract: Not Available at the Time of Production.


Dalziel revisited; Electric shock analysis of mixed bipolar and monopolar waveforms Peter Perkins (P. E. Perkins PE, USA)

Abstract: In his 1943 paper Professor Charles F Dalziel extended his Let-go effects analysis to mixed AC and DC waveforms plus various shaped non-sinusoidal waveforms to determine reasonable safe current limits feeling that it could be applied to any waveform. This paper revisits his analysis and extends it to modern non-sinusoidal waveforms to provide a substantiation for application of this analysis to non-sinusoidal touch currents found in modern electronic equipment.

30

Time: 9:30 - 10:30 AM Room: San Simeon

Global Market Access Regulatory Changes in China – 2018 Vanessa Wen (CSA Group, Canada)

Abstract: China market is of one of the markets that has attracted many manufacturers due to its fast growth economy and large consumption demand. Understand Chinese market environment and catch up with the latest regulatory changes are crucial for manufacturers doing business in China. In this presentation, we are to present several important changes in China regulatory compliance industry that happened in 2018 including the new market regulator SAMR, major changes in compulsory certification CCC, state radio agency new policy as well as the newly implemented CCIS certification to telecom product cyber security. Our goal is to present a solid understanding and guidance of the new changes with specific details that address the main concerns targeted audience may have, certification scope, comparisons of the scheme before and after are included.

Time: 10:40 - 11:40 AM Room: San Carlos

Compliance 101: Touch-current / Electric shock tutorial Peter Perkins (P. E. Perkins PE, USA)

Abstract: This tutorial covers the basis for electric shock protection in electrical equipment. It is build upon the response of the human body to electric current and the ways in which to deal with this in equipment design and evaluation. The methods are technically based upon IEC standards such as IEC 60479, 'Effects of electric current on the human body...' and IEC 60990 'Methods of measurement of touch current...'. A comprehensive presentation of the understanding and application of the needed protections will be presented. This tutorial is aimed at engineers and managers working on equipment design and construction as they have to deal with these issues. The author/presenter has more than 50 years experience in the electronics field.

.


Experiments of DC Human Body Resistance II: Test Results and Analysis of Data from Fifty-Two People

Hai Jiang (Underwriters Laboratories (UL), USA) Paul Brazis (Underwriters Laboratories (UL), USA)

Abstract: This paper describes the second phase of an experimental investigation into DC human body resistance conducted by the authors. 25 women and 27 men participated as test subjects for this work, each completing two iterations of a set of three measurements. These measurements evaluated the hand-to-feet and hand-to-hand current pathways under both dry and wet (simulated sweat) conditions. At each test condition at each test voltage the data were found to follow a log-normal distribution. Percentile results are calculated based on the fitted log-normal distribution and compared to the IEC 60479-1 body resistance data. It is found that the measured body resistance values in this work were higher than the IEC values, though this may be attributed to differences in the skin contact interface (conditions of which are not fully disclosed in IEC 60479-1). Female volunteers exhibited body current values on average 70-75% than the average values for male volunteers and are likely attributable todifferences in average body mass rather than some gender-specific cause.

31

Time: 10:40 - 11:40 AM Room: San Martin

Korea Market Access for Electrical and Electronic Equipment Michael Chang (Eurofins MET Labs, USA)

Abstract: The market access for South Korea has been essential for many manufacturers, yet there are many challenges in understanding the regulatory requirements to successfully enter this market. This presentation provides the general requirements and approval procedures for various KC certification schemes for the electrical and electronic equipment.

Time: 10:40 – 11:40 AM Room: San Simeon

Understanding and Investigating Burn Injury Kenneth Lee (Exponent, USA)

Abstract: Burn injuries are a common occurrence in industrial settings and everyday life, and often involve consumer products. Despite the prevalence of burn injuries, understanding the burn risks that may accompany industrial processes or commonplace consumer products, as well as investigating these types of injuries, can be a difficult task. The basis for our current scientific understanding of burn injuries is formed by a few landmark studies involving the quantification of burn severity under different thermal exposures. These studies also form the basis for consensus standards (such as ASTM and ISO standards) that provide guidance for assessing the risk of burn injuries. These standards are frequently misinterpreted when used in the context of product safety. Understanding the mechanics of burn injuries, the way in which consensus standards apply or don't apply, and the available tools for evaluating burn hazards are all indispensable to any investigation involving burn injuries. By bringing scientific rigor to the analysis of burn injury hazards, an understanding of the cause of injury becomes clearer. Multiple cases studies will examine typical issues that arise in consumer product safety involving burn injuries and the different tools available to address these issues.

32

Time: 1:10 - 2:10 PM Room: San Carlos

69 kV Sub-Transmission Line, a Careless Painter and a Scissor Lift - A Potential Electrical Hazard

Nosh Medora (IEEE & Exponent, USA) Ashish Arora (Exponent, USA)

Abstract: Electrocutions in low voltage systems usually occur when a person comes in direct contact with an energized conductor or when a conductive contaminant creates an electrically conductive path across an insulating member. However, unlike low voltage systems where the hazard is typically associated with direct contact, being in close proximity to sub-transmission voltages (within the arc flash hazard boundary) can result in a hazardous condition due to the development of an arc with high current conduction that can propagate into a full-body arc. The arc releases an extremely high level of thermal and acoustical energy, with a high-pressure wave and flying debris. This can result in extensive burn injuries, including third, fourth and fifth degree and higher burns to the internal organs. This presentation, with events extracted from an actual case study, illustrates what happened when a person - in this case a painter in a scissor lift accidently approached an energized 69 kV utility sub-transmission line. The presentation will include a brief history of the events and the consequences that resulted when the painter entered the air breakdown voltage boundary. The presentation will also include a computer simulation using an arc model featuring information obtained from various IEEE publications and other references. The simulation model will include three-phase line voltage sources, with transformer impedance Z and with R-L-C line impedances. The results will include waveforms of voltage, current and power through the painter's body and the utility line unbalanced conditions caused by the high current single-phase fault. The computer simulation will include voltage and current waveforms for three conditions: 1. Normal operation - with transformer and line parameters and with utility connected load 2. Arc flash - painter enters the arc flash hazard boundary 3. Full body arcing event the results will also include data showing the expected arc temperatures. The objective of this presentation is to review and investigate the hazard conditions created due to operator negligence in close proximity to sub-transmission electrical systems. The objective is also to determine the voltages and currents involved when such an incident occurs, and thus to enhance the importance of abiding by existing safety measures that are regulated by safety codes and standards.

Time: 1:10 - 2:10 PM Room: San Juan

Compliance 101: Applying Toy Safety Standards To Your Consumer Electronics Product Dan Roman (Colgate-Palmolive Company, USA)

Abstract: This presentation will discuss additional requirements that designers and safety professionals may want to consider beyond the base standard for their product based on the environment and user exposure. The example used in this paper is the consideration of toy safety requirements for ITE or CE products when children are likely to be present.

33

Time: 1:10 - 2:10 PM Room: San Martin

Realization and maintenance of a regulatory compliance;the devils in the details, yet the details are overwhelming! What to do?

Roger Martin (Compliance Dynamics, LLC, USA) Patrick J Dugan (LEAP4, USA)

Abstract: In today's global environment it is increasingly difficult for companies to efficiently realize and maintain their products/services regulatory compliance. In the locus of new product development teams are focused on regulatory requirements, yet once a product is released the focus can become muted, where compliance becomes a maintenance activity (with often times limited resources). This talk will focus on approaches for compliance maintenance leveraging business process and product lifecycle management tools to maintain, and more importantly, trigger actions to remain in compliance. This solution, a "Single Source of the Truth", effectively and efficiently leverages the same data to address not only your internal business practices, but also efficiently fulfilling your compliance needs as well.

Time: 1:10 – 2:10 PM Room: San Simeon

Safety of Free-Space Optical Communication Systems Don Gies (DDG Compliance, LLC)

Abstract: This paper examines the optical safety considerations of free-space optical communication systems (FSOC). These telecommunication systems communicate over distances through free space using optical communication technology. Topics include eye safety, restricted access, IEC 60825-1 and IEC 60825-12 compliance, and safety considerations for aviation pilots from laser light. FSOC systems would be expected to comply with IEC 62368-1, coordinated with IEC 60950-22 for outdoor systems, as well as the aforementioned IEC 60825 standards.

Time: 2:20 - 3:20 PM Room: San Carlos Ballroom

Consumer Electronics - Basic Product Safety Julio Posse (Sony Electronics Inc., USA))

Abstract: An overview of a practical approach to product safety for consumer electronics products. Description of common risks associated with these products and measures to mitigate these risk. Brief description of IEC 62368 Hazard Based concept and its application as it relates to the risks addressed in the presentation.

34


Illumination Caused Permanent Bodily Injury, Photons Not Taken Lightly Louis Bilancia (Engineering Systems, Inc., USA) Ashley Giesa (Engineering Systems, Inc., USA) Keith Cline (Engineering Systems, Inc., USA)

Abstract: It is no surprise that different wavelengths of light can cause injury to exposed living tissue. In this case study, hospital maintenance and/or cleaning staff did not recognize the seriousness of removing the IR and UV filters from a halogen bulb operatory luminaire. It is estimated that more than 1,000 individuals could have been exposed to the unfiltered light and several were diagnosed with severe tissue damage; at least one case was untreatable. This paper outlines the instrumentation and calculations performed to evaluate the seriousness of the risk of unfiltered artificial light.


Market access for wireless products in Europe and South America Julia Gresser (CSA GROUP, Germany) Polux Sanchez Reyes (CSA Group, USA)

Abstract: Wireless functions and technologies are becoming more and more prominent and relevant. Wireless networks and related wireless devices are driving our ever more connected world increasing the need for manufacturers to understand the requirements to bring their products to market. This session will provide a solid foundation and understanding of the general principles and requirements, as well as the approval process to gain access to the European and South American markets, with a particular focus to Argentina, Brazil and Mexico.

Time: 2:20 – 3:20 PM Room: San Simeon

The Need for a New (or Redefined) Discipline: Product Health and Environmental Safety Engineering

Michael Kirschner (Design Chain Associates, LLC, USA)

Abstract: "Going green" is - in reality - not a performance or competitive issue, it's a safety issue. Too often, manufacturers address or solve other safety issues, such as flammability, by displacing the problem to the health and environmental safety domain. This happens because the industry collectively and manufacturers individually enable it through inadequate standards, expertise, management and control. Without a complete and holistic approach to product safety, including human health safety and environmental safety, can we truly say our products are "safe"? Is meeting a broad product safety standard like IEC/UL 62368-1 adequate in light of this? I will explore this gap in product safety, provide examples and discuss the rationale for and challenges to closing the gap technically, operationally and philosophically.

35


Beyond the basics: Save the trauma for when it really count Lars Mellander (Testing-Compliance & Nemko USA, USA))

Abstract: This presentation is intended to inform of the common pitfalls that hinder the successful Global Market Access launch of your product. We will go into the specific details surrounding the essential considerations that will impact your success. These considerations include: the product type, the markets you intend to sell into, power system considerations, regulatory model numbering scheme, trademark identification, labelling, factory locations, critical components and more; and the importance of having these essential considerations at the 'top of mind' at a very early stage of planning the product launch.


Key Considerations and Challenges with IEC 62368-1 Leszek M Langiewicz (HP Inc., USA)

Abstract: This presentation will discuss major differences between IEC 60950-1 and IEC 62368-1 and key considerations and challenges of IEC 62368-1.

Time: 3:50- 4:50 PM Room: San Martin

Navigating the Product Safety Certification Cycle: Using Early Engagement and Best Practices to minimize Project Risk

Christopher Kincaid (CSA Group, USA) Mitchell Rushing (CSA Group, USA)

Abstract: Launching a new, innovative product into the marketplace can be a challenging endeavor. A critical component of the product design and development process involves third-party testing, inspection & certification. The certification process, if not planned and executed properly, can derail product launch dates, lead to costly re-designs, lost revenue and missed market opportunities. Utilizing Best Practices and Early Engagement can help minimize Project risks.

36

Time: 3:50 - 4:50 PM Room: San Simeon

Tin whiskers and automotive electronics Michelle L Kuykendal (Exponent, Inc., USA) Daniel Kingsley (Exponent Inc, USA) Ashish Arora (Exponent, USA)

Abstract: Tin whiskers are small, hair-like structures that can form naturally from the surface of tin components. While the mechanisms by which tin whiskers form are poorly understood, their potential effects are well documented: they can cause short circuits and arcs within electrical devices, damage MEMs, and interfere with the operation of optical components. As automotive systems become increasingly reliant on integrated electronics, the potential for reduced functionality or damage resulting from tin whisker formation increases; however, because the factors that contribute to whisker growth are still debated, design practices, testing standards, and mitigation processes to address tin whiskers have not matured. We discuss potential contributors to tin whisker growth, failure mechanisms that may be induced by whiskers, current testing standards and processes, and mitigation strategies, with a particular focus on the automotive industry.


Managing Product Safety Knowledge Mike Sherman (Graco Inc., USA)



Going Global: Wireless Handbook for helping manufacturers bring wireless devices to the global market Theresa Glenna (TUV SUD America Inc., USA)

Abstract: One of the biggest challenges today is effectively rolling out a new wireless product while minimizing the time and cost involved. We will discuss strategies for integrating wireless transmitters into products and the impact on testing and certification on a global level. We will highlight some testing strategies which can significantly reduce the time to market and avoid the occurrence of retesting. Using specific examples, we will share a number of ways customers can develop a plan to meet their market access goals.

37


Product Designing for a Circular Economy David Linder (SGS North America, USA)

Abstract: Electrical products, circular economies and waste management… There has been a voluntary and sometimes mandatory shift away from the traditional product cycle, or 'linear economy', to an environmentally and sustainable 'circular economy'. In a linear production model, the progression is to make, use and then dispose of a product, which basically produces waste. The approach of a circular economy is to re-purpose, reuse and/or recycle the components and materials found within a product. Natural resources are used for as long as possible, which may create new economic opportunities while also helping to minimize the environmental impact. Therefore, the intent of a 'circular' business practice is: a) to minimize the use of raw materials; b) to maximize the useful life of materials and other resources through resource recovery, and; c) to minimize waste generated at the end of life of products and packaging. Improving waste management and efficiently using materials are some of the ideals behind a sustainable environment and circular economy. To produce products which adhere to these economic principles, design engineers, in conjunction with purchasing/procurement, need to understand the materials being used and the regulations in place to protect the environment. Knowing and understanding the supply chain becomes very important to the process. The idea of a circular economy is more than just a good idea, as many countries are requiring products to meet specific hazardous material and sustainability standards. Manufacturers will need to know their products and develop specific end-of-life plans for reusing or recycling. This presentation will examine the material requirements, recycling and life-cycle assessment tools to ensure that you are asking the right questions to obtain the information that will be most relevant to achieve your environmental and sustainability goals in a circular economy.


Panel discussion 62368-1

38

TUESDAY, MAY 7, 2019


An Introduction to Hazardous Locations - Basics and Protection Concepts William Fiske (Intertek Testing Services NA Inc., USA))

Abstract: The presence of flammable atmospheres, also known as hazardous (classified) locations, presents unique risks to persons and property when electrical equipment is installed and used in such areas. As the atmosphere itself is readily ignitable, the risk of an explosion or flash fire is greatly increased. This paper describes what a hazardous location is, the unique risks presented, methods of protecting against explosion, standards for equipment and for its installation and use, and explains regional and international conformity assessment systems.


Brazil Spotlight - INMETRO Safety for ITE, HOUS, MED and Ex, Anatel for Wireless and Energy Efficienc

Theresa Glenna (TUV SUD America Inc., USA)

Abstract: A comprehensive look at four different certification areas in Brazil. For each of these schemes, we will explain: mandatory products in scope, testing and approval process, documentation needed, and tips for a smoother path to market access.


Overview of RF Exposure Requirements Grace Lin (Intertek, USA) Nicholas Abbondante (Intertek, USA)

Abstract: Many wireless devices are subject to routine environmental evaluation for RF exposure prior to equipment authorization. This presentation provides an overview of RF exposure requirements. With this understanding, applicants can ensure environmental assessment is appropriately prepared, an important step toward regulatory approval.


Practical Methods for Establishing a Product Safety Program


39


Creating HazLoc Product and Compliance Guidelines for the Marijuana Industry Linn Havelick (5902 McIntyre Street & HAL Extraction Technology Ltd., USA)

Abstract: The cannabis oil extraction industry existed only in a clandestine world until 2014 when the State of Colorado made recreational marijuana legal. The state of the art for extraction at that time was running liquid butane from a camp stove bottle through a tube packed with cannabis. The loaded solvent was then separated from the raw oil by evaporating it into the atmosphere. Many fires, explosions, and injuries resulted. The first engineering and industrial hygiene professionals who worked with the industry faced numerous challenges - from stoner business owners to a workforce with no process chemistry knowledge base. Achieving compliance with building and fire codes for novel facilities and equipment was a journey fraught with challenges. Few standards existed to apply to products being developed for plant oil extraction equipment. Nationally recognized testing laboratories were reluctant to associate with an industry still illegal at the Federal level. Achieving the first equipment standard in this environment was a learning experience. This presentation describes a journey with an industry rapidly evolving from the world of gangsters and dopers toward respectability.


Part 1 of 3: Introduction to EMC Compliance- Printed Circuit Board and System Design

Mark Montrose (Montrose Compliance Services, Inc., USA)

Abstract: This half-day tutorial allows engineers to learn and understand the field of electromagnetics and its' relationship to compatibility requirements regardless of application or environment of use "without complex math or calculus". We begin with simplifying Maxwell's equations into four simple algebraic equation that easily describes the entire field of EMC for real products, not the theoretical field theory which Maxwell published which also has no direct relationship to circuit or system design. Maxwell Made Simple is then applied to printed circuit board design and layout using three basic areas of concern associated with both signal integrity and EMC compliance; proper transmission line routing, referencing (a.k.a. grounding) and power distribution (bypassing and decoupling). Building on fundamental concepts associated with PCB layout we then examine what happens at the system level which includes shielding and filtering. The target audience are those who want to understand what EMC is at a simplified but comprehensive level. Senior EMC engineers will also benefit from learning a new way to visualize and work with EMC issues, or how to solve difficult problems in a unique, fun manner.


Regulatory Update for the US and the EU: Legal requirements for distributing products online; current market surveillance programs; new developments with regard to environmental product law (WEEE-Directive)

Susanne Wende (Noerr LLP, Germany)

Time: 10:50 - 11:50 AM 40

Room: San SimeonWhat in the World? A update on the latest international requirements (EMC/Safety)

Lars Mellander (Testing-Compliance & Nemko USA, USA)

Abstract: This presentation will be a current/active presentation that will cover the latest changes in various global markets. As the rules and regulations seem to be changing on a daily basis, this presentation will look to advise on the most recent changes and how best to prepare for them.


Legal Implications for Product Distribution after Brexit Susanne Wende (Noerr LLP, Germany)



Optimizing supply chain communication with respect to requirements under RoHS, REACH

Eva S. Hink (iPoint-systems GmbH, Germany)

Abstract: Optimizing supply chain communication with respect to requirements under RoHS, REACH et al. European legislation such as REACH or RoHS is asking for detailed information about substances in articles. - Although REACH SVHC are not subject to restriction, information about their presences has to be shared throughout the supply chain. - Already in 2015, the European Court of Justice has ruled, that the threshold of 0.1% for the information obligation about substances of very high concern (SVHC) in so called articles, has to apply on any single product in a complex article instead of taking the weight of the whole article for calculation. - A change in the European Waste Framework directive is now requiring the European Chemical Agency (ECHA) to setup a central database where information about SVHC has to be submitted by suppliers of articles by 2021. The database shall provide this information to waste treatment operators as well as consumers. - REACH Annex XVII restrictions are growing constantely - recently restrictions on 4 phtalathes have been published that will apply to a wide range of products being put on the EU market - Under RoHS new substances are under review to be added to Annex II of restricted substances that will apply in the future. - Existing RoHS exemptions have to be extended by submitting an application, some exemptions will run out in the future. New exemptions are published and will be applicable for some years. Manufacturers need to be aware about substances and applicable exemptions in their products. All these obligations and activites require manufacturers of articles and electronics to establish an ongoing communication process in the supply chain. The presentation will show the basics requirements and the latest developements regarding REACH/RoHS with respect to supply chain activities. It will provide recommendations and possible solutions taking into considerations the variety of Contracting, CoCs, Partial and Full Material Declarations as well as risk assessments' results.

41


Part 2 of 3:Introduction to EMC Compliance- Printed Circuit Board and System Design


Abstract: This half-day tutorial allows engineers to learn and understand the field of electromagnetics and its' relationship to compatibility requirements regardless of application or environment of use "without complex math or calculus". We begin with simplifying Maxwell's equations into four simple algebraic equation that easily describes the entire field of EMC for real products, not the theoretical field theory which Maxwell published which also has no direct relationship to circuit or system design. Maxwell Made Simple is then applied to printed circuit board design and layout using three basic areas of concern associated with both signal integrity and EMC compliance; proper transmission line routing, referencing (a.k.a. grounding) and power distribution (bypassing and decoupling). Building on fundamental concepts associated with PCB layout we then examine what happens at the system level which includes shielding and filtering. The target audience are those who want to understand what EMC is at a simplified but comprehensive level. Senior EMC engineers will also benefit from learning a new way to visualize and work with EMC issues, or how to solve difficult problems in a unique, fun manner.


Training on the Oil & Gas Industry - Overview of Upstream/Midstream/Downstream John Chambers (UL LLC, USA)

Abstract: This presentation will cover the facets of the Oil & Gas industry from Exploration & Drilling to the End User product at an introductory level. It will provide an overview of the energy mix and how important Oil and Gas is to the current infrastructure in society. It will cover where Oil & Gas affects Products, People and the environment we live in. Transport only accounts for 70% of the oil & gas usage globally with no signs of decline, and the energy mix changes globally. As the developed nations transition to renewable's, less developed nations are starting to use more Oil & Gas as they move forward. Hazardous Locations are ever present from the energy source to the point of delivery of the commoditized and non-consumable products and services. This industry is demanding tangible, proven developments from the current Digital Transformation from Industry 4.0 and a huge part of the estimated $1T Industrial 'Internet of Things' forecast will play out in this sector. By the end of the session, attendee's will better understand where the Hazardous Locations technical compliance challenges are created, and are mitigated through the whole oil & gas supply chain, and remind the audience on how critical the industry is to society in the medium to long term. Also, there will be insight into where IIOT can optimize the whole supply chain from edge device - through the cloud - into the hands of the user, including mixed reality.

42


BRIC Product Compliance (Brazil, Russia, India, & China) Mark W. Maynard (American Certification Body, Inc. & Washington Laboratories, Ltd., USA

Abstract: The four countries of Brazil, Russia, India, and China, referred to as the acronym "BRIC", are four popular global market countries for electronic and high-technology products, with a combined population of over three billion. Each has their own unique regulatory compliance agencies and standards, requiring specialized knowledge and awareness of local business practices. This presentation provides an overview of the requirements for electronic product compliance for these countries, including the product testing and submittal requirements, along with recommendations for a successful product certification project in each.


OSHA's Nationally Recognized Testing Laboratory Program - On the Verge of Change

Kevin Robinson (Department of Defence, USA)

Abstract: The Nationally Recognized Testing Laboratory (NRTL) Program has shaped the world of product safety compliance in the United States for over 40 years, and OSHA is on the verge of releasing a significant update to its policies and interpretations of OSHA Regulations that have been in place for 20 years. Explore a brief history of the NRTL Program, and the unique partnership that has developed between the public and private sectors, and be one of the first to learn about the changes being made to the NRTL program and what impact those changes will have on ordinary location equipment and equipment used in potentially explosive atmospheres. Bio: Kevin Robinson is the Director of the Office of Technical Programs and Coordination Activities (OTPCA) within the Occupational Safety and Health Administration (OSHA), and is responsible for administering OSHA's Nationally Recognized Testing Laboratory (NRTL) Program. Kevin has more than 20 years of experience in the Product Safety Testing and Certification industry and has been working in OSHA's NRTL Program for 10 years. Prior to joining OSHA, Kevin worked for the Consumer Product Safety Commission (CPSC) in the Office of International Programs where he provided technical consultation for Agency leadership and served as a negotiator for cooperative agreements with CPSC's international counterparts. Prior to his Federal Service, Kevin served as Technical and Quality Assurance Manager at MET Laboratories, one of the first organizations to be recognized by OSHA as an NRTL. In this capacity he served as the senior technical advisor for an international product testing and certification body. Kevin graduated from the Rochester Institute of Technology with a Bachelor's degree in Electrical Engineering Technology and has been designated by the International Association for Radio, Telecommunications and Electromagnetics as a Certified Product Safety Engineer and is the recipient of two Exceptional Achievement Awards from the Secretary of Labor.

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Part 3 of 3:Introduction to EMC Compliance- Printed Circuit Board and System Design


Abstract: This half-day tutorial allows engineers to learn and understand the field of electromagnetics and its' relationship to compatibility requirements regardless of application or environment of use "without complex math or calculus". We begin with simplifying Maxwell's equations into four simple algebraic equation that easily describes the entire field of EMC for real products, not the theoretical field theory which Maxwell published which also has no direct relationship to circuit or system design. Maxwell Made Simple is then applied to printed circuit board design and layout using three basic areas of concern associated with both signal integrity and EMC compliance; proper transmission line routing, referencing (a.k.a. grounding) and power distribution (bypassing and decoupling). Building on fundamental concepts associated with PCB layout we then examine what happens at the system level which includes shielding and filtering. The target audience are those who want to understand what EMC is at a simplified but comprehensive level. Senior EMC engineers will also benefit from learning a new way to visualize and work with EMC issues, or how to solve difficult problems in a

unique, fun manner.


Using Product Testing in Litigation



Bluetooth Certification Tom Tidwell (Nemko USA, Canada)

Abstract: This presentation will discuss what is required when implementing a Bluetooth radio into a product. The process to gain or maintain Bluetooth Special Interest Group (SIG) certification on a product and the technical requirements that must be met.


New regulations of China CCC, SRRC and NAL Paul Wang (G&M Compliance & G&M Compliance, P.R. China)

Abstract: This presentation introduced the new regulations about China certifications. For CCC, the updated CCC product category, SDoC, GB standard update and technical committee decisions are illustrated; for SRRC and NAL, the new system requirement about sample and documents are illustrated

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Post-Sale Duties and Defending Post-Recall Lawsuits



The Evolving Landscape for Global Hazardous Locations - Considerations for Equipment Certification

Christopher Kincaid (CSA Group, USA) Nicholas Cameron (CSA Group, Canada)

Abstract: Despite challenging economic circumstances, HazLoc Industries continue to grow and undergo rapid globalization, resulting in differing safety compliance requirements for equipment being used across international borders. At the same time, the risks the HazLoc industry poses to workers and the general public has never been more prevalent or under more public scrutiny. Manufacturers and suppliers are challenged to ensure their equipment complies with local government, regulatory and international safety standards - a process that can be both lengthy and costly, and can vary from region to region. Speed to market matters and understanding how to access global markets quickly, without sacrificing equipment safety and quality, is the key to survival in today's competitive international markets. This presentation will focus on the current make-up of the HazLoc sector today, looking at the basic principles that define a Hazardous Location, and the various schemes, directives and legislation globally that govern its compliance. Speed to market matters and understanding how to access global markets quickly, without sacrificing equipment safety and quality, is the key to survival in today's competitive international markets. This presentation will focus on the current make-up of the HazLoc sector today, looking at the basic principles that define a Hazardous Location, and the various schemes, directives and legislation globally that govern its compliance, as well as identifying best practices, and trends within Hazardous Location certification.


Citizen's Broadband Radio Services and OnGo Certification Tom Tidwell (Nemko USA, Canada)

Abstract: An overview of this new wireless technology and the regulatory requirements for use of the band. The process for testing the radio network access parameters.


Latest Country Regulatory Update James A Bacher (JB Consulting, USA)

Abstract: This presentation will Walk through multiple countries regulatory requirements in summary which includes product safety, EMC, Energy Efficiency, Wireless approval etc, present what current regulatory requirements are and what recent changes are.. The presentation will give audience a good overview on 8 countries (China, India, Indonesia, Singapore, Korea, Saud Arabia, S. Africa and Ukraine) regulatory requirements and bring up to date experience on changes that may impact the manufacture's current certification process, provides insight info for what to expect in near future to be prepared.

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Power Supply Safety Gary Tornquist (Consultant, USA)



Unmanned Robots and Drones in Global Hazardous Locations Paul T. Kelly (UL LLC, USA)

Abstract: Whether flying through air (e.g. drones), crawling over ground (e.g. robots), or swimming on or under water (e.g. saildrones), remotely or autonomously controlled vehicles have established their benefits in ordinary (unclassified) locations. These benefits include monitoring, exploration, protection and delivery. Now, the benefits of these unmanned vehicle systems are being recognized in hazardous (classified) locations. Learn about the progress and challenges associated with the use of these vehicles in explosive atmospheres.

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WEDNESDAY, MAY 8, 2019


India TEC (Telecommunication Engineering Center) Lars Mellander (Testing-Compliance & Nemko USA, USA)

Abstract: TEC is certainly a major new compliance requirement in one of the largest and fastest growing markets in the world. Nearly every company in the IT industry must at least consider the implications of TEC if India is a current or future market. This presentation is a general overview of the products that apply, the rules and processes...and how to possibly navigate in the very rough weather that TEC will be.


Material and Substance Requirements for EEE, Conventions, Treaties, Surveillance, REACh and, of course, RoHS

David Linder (SGS North America, USA)

Abstract: There are many reasons that manufacturers need to ensure products are in compliance with all applicable material restriction regulations. Market surveillance can lead to product recalls, and/or non-compliance penalties, which can be expensive. But bad publicity may be even more costly. Manufacturing products which adhere to performance and safety requirements are commonplace, but more and more the materials being used within these products are being scrutinized. Disposal, recyclability and end-of-life concerns have also become very important. From design to production, everyone who is involved with the manufacturing process of electrical and electronic products needs to ensure that all regulatory and market requirements are being met before the first product leaves the dock. Purchasing needs to procure materials which are compliant with requirements and also meet engineering specifications. Production needs to ensure that nothing 'bad' is added during the manufacturing process. All departments need to work hand-in-hand to ensure that the requirements of any new market are known before shipments are made. There is ongoing market surveillance, and databases of recalled products. While the information on hazardous products and materials is public knowledge, understanding the local market and product requirements is essential important to know before shipping any products. This presentation will include information on the various international laws, treaties or other dangerous substance regulations or conventions currently adopted throughout the world.

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Security Risk Management for IoT Devices - Standards, Methods, and Insights Laura Elan (CSA, USA

Abstract: Risk Management is a core process for the identification, evaluation, control, and management of risks affecting product safety. Many industries have adopted risk management activities, including Failure Mode and Effect Analysis (FMEA), Hazard and Operability assessment (HAZOP), Fault Tree Analysis (FTA) and the like as a part of their product development lifecycle. However, new technologies and architectures such as networking technologies, e.g. IoT enabled devices, pose new risks to be considered including exposure of sensitive data, malware, and unauthorized access to networks and assets. Manufacturers must have the know-how to address cybersecurity threats but the thinking and processes are different than traditional risk assessment. Our presentation will provide an overview of the differences between traditional safety-based risk management and Security Risk Management, also called Threat Modeling. We will examine several standards and methodologies that have been adopted across specific industries, including Medical Devices, Consumer Devices, IT, and IoT. To conclude, we will present a set of best practices and resources that manufacturers may use to assure IoT and/or network connected products and systems include risk controls that improve resiliency against security risks.


The Heated Needle Penetration Method for Li-ion Thermal Runaway Initiation Dustin Summy (Exponent, Inc., USA) Matthew Horowitz (Exponent, Inc., USA)

Abstract: Many lithium-ion battery thermal runaway initiation methods show poor reliability or poor authenticity (i.e., the method is not representative of a spontaneous self-initiation). With the increased prevalence of wearable devices, improved methods of initiating thermal runaway can be helpful in assessing product safety. We introduce a new method for achieving thermal runaway in lithium-ion batteries and cells wherein one or more needles penetrate the battery and are heated by the application of DC current from an external power supply. The intended method of thermal runaway initiation is by heating of the needle tip(s) to temperatures sufficient to create a small seed-zone where conditions for thermal runaway are met; the cell then progresses through the thermal runaway process as it would naturally after a spontaneous internal event. This method represents a combination of the simplicity and authenticity of the standard nail penetration method with the reliability of forced global heating of the cell. We show results from exemplar testing of small-capacity Li-ion cells which demonstrate the advantages of heated needle penetration over selected traditional methods in such applications.

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Time: 9:10 - 10:10 AM Room: San Carlos Ballroom (Im)Perfectly Safe

Dan Roman (Colgate-Palmolive Company, USA) Craig Harvey (Colgate, USA) Jason Magby (Colgate-Palmolive Company, USA) Daniella Urbach Ross (Colgate-Palmolive Company, USA)

Abstract: Paper will discuss chemical substances sometimes found in electronic products that get bad press, but for which there is no sound toxicological science that should require bans at levels used.


Telecom Regulatory Updates Affecting 2019 Approvals in Latin America Elizabeth Perrier (Product Regulatory Compliance- Latin America & Orbis Compliance LLC, USA)

Abstract: This presentation addresses regulations affecting telecommunication approvals in Argentina, Mexico, Brazil and Chile for 2019. The regulatory agencies for these countries, and the testing and certification processes required, are also discussed.


The Overlooked Critical Factor - 5 questions to ask when designing your battery-operated product

Rodney Grimes (SGS North America, USA)

Abstract: In a world of technology, the number of items powered by a battery is surprising. From toys and wearable technology, to common household appliances and cell phones, batteries have taken over the landscape. Even though batteries are prevalent across the consumer products industry, it is still considered one of the most overlooked, yet critical factors in a product. Consumer products exploding due to battery malfunctions have sprinkled the news in the past few years, causing large scale recalls and shaking consumer confidence in brands they used to trust. Don't let this be your story. There are five key questions that you need to consider when designing your battery-operated product. These questions will help you determine which battery will best suit your product's needs and help you clarify the kind of safety testing you need to do to get your product into your chosen market. The landscape for batteries is constantly shifting as consumer demands change and technology improves. The continual improvement that is transforming the battery industry is also transforming the changing the regulations as well. Be prepared for the new wave of consumer products, fueled by the batteries of the future.

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Topological Vocabulary for Supporting Conformity Assessment of Interoperable Medical Products

John Hatcliff (Kansas State University, USA) Eugene Y. Vasserman (Kansas State University, USA)

Abstract: Health care delivery is increasing relying on interoperable components and medical systems built from those components. Describing the abstract topology of such products and their interactions with their contexts is a key step in risk management and conformity assessment. Abstract topological descriptions are used in preliminary risk analysis, planning for quality management system coordination, planning for detailed architecture descriptions, organizing development activities, and scoping assurance and conformity obligations. In this paper, we present high-level goals for a topological vocabulary for interoperable medical components and systems as needed to support conformity assessment. We indicate how the topological vocabulary occurring in existing medical standards is insufficient for dealing with the complexities of interoperable medical systems. We then propose topological terms and definitions, explain their use in development of systems in which regulatory oversight or third-party certification is required, and we illustrate the terms with a series of increasingly complex interoperable products.


Alternate Low Power Modes Ted Eckert (Microsoft Corporation, USA)

Abstract: Smart phones have become ubiquitous, and users have grown accustomed to the instant-on experience. They expect their phone to update messages and apps when it is in sleep mode, and they expect it to wake quickly. Operating systems are evolving to provide new sleep modes that can provide a similar experience on more traditional computers. Many operating systems now have Alternate Low-Power Modes (ALPMs) that reduce power consumption to levels comparable to older sleep modes while maintaining a level of activity that can keep mail, messages and apps up to date. These new alternate low-power modes also allow for fast resumption of operation that is close to an instant-on experience. Implementing these modes allows the OS to go into ALPM after very short periods of inactivity, thereby reducing energy consumption. This reduction in power consumption can be used to help computers meet new and strict energy limits. This presentation discusses the new power modes, shows how they save energy and discusses some of the issues with testing.

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Room: San Juan

Application of Blockchain Technology to Laboratory Operations Leslie Bai (Bureau Veritas)

Abstract: The application of Blockchain technology to laboratory operations will certainly ensure protection of data security, measurement traceability, and un-revertible test records, but also improves the operation process, increases the productivity and lab efficiency. This paper introduces the application of the Blockchain technology on the laboratories operations and shows how to increase the efficiency and productivity. This paper will not address the data security and traceability but focus on the value of the application of Blockchain technology on lab productivity. A typical EMC test lab was taken as an example to show how the blockchain technology is applied. The result of the productivity and efficiency is derived from the application of the blockchain technology.


Current Trends in Electromedical Equipment Standards Naysahn Saeed (CSA Group, USA)

Abstract: Major advances in medical technologies over the last few decades have contributed to early diagnosis of diseases, more efficient delivery of treatment, and longer healthier lives. From switches to swipes, from hardware to apps or from the hospital to the home environment, healthcare devices continue to undergo a paradigm shift. To keep up with these advances, and to compete in a highly competitive and complex market, healthcare systems and medical devices must evolve to support and reflect this rapid pace of innovation. Ensuring that these systems and devices are safe for usage by both trained medical professionals as well as inexperienced home users is critical to business success and public safety. As a result, manufacturers find themselves in a constantly changing environment of safety, conformity and market access requirements - an environment in which they cannot afford to fall behind. This presentation will provide an overview of the current trends in electromedical equipment standards, as it relates to IEC/ISO 60601 series of standards, including an introduction of the history of the medical robot and future considerations medical robotic applications. Upon completion, participants will enhance their knowledge in the following key areas: Basic safety and essential performance requirements for electromedical equipment Medical robotic definitions and applications

Time: 10:30 - 11:30 AM

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Keith Beers (Exponent, Inc., USA) Rachel Licht (Exponent, Inc., USA)

Abstract: Consumers and industry leaders are becoming increasingly concerned about the safety of their lithium-ion battery powered products. While lithium-ion technology is relatively mature at this point, achieving a safe product still relies on consistently well-manufactured cells, a proper battery design, and appropriate qualification of the battery for its intended application. For many vendors of lithium-ion-battery-containing products, qualification is an ill-defined process that typically involves testing according to required standards and, in some cases, to additional voluntary standards. These standards focus on generic abuse and potential misuse scenarios. Few vendors go beyond this rudimentary testing, and thus many potential failure modes particular to the use case of the specific device go undetected. In this talk, we will discuss tools and methodologies that can be used to characterize batteries during qualification to learn more about a battery and gain added understanding about the possibility of performance or safety issues that could appear in the broader population once released in a product. Case studies utilizing non-destructive and destructive techniques to characterize batteries that pass the common qualification protocols (i.e., abuse standards and room temperature cycle life testing) to assess for the possibility of latent issues will be presented. These tools and this discussion will be broadly applicable to lithium-ion batteries of varying form factors (e.g., 18650s and pouch cells), chemistries (e.g., lithium cobalt dioxide and lithium nickel manganese cobalt dioxide), and applications (e.g., consumer electronics, medical devices, and automotive).


Applying Functional Safety in the Battery System for Electric and Autonomous Vehicles

Yike Hu (Exponent, USA) Ken Ferguson (Exponent, USA) Bala Pinnangudi (Exponent, USA)

Abstract: Functional safety is a key issue of future automotive development. Integration of the increasing technological complexities across a variety of new functionalities in electric and autonomous vehicles demand the implementation of the safety system and validation that all reasonable system safety objectives are met. ISO 26262 provides a framework and process to avoid risks from systematic failures and random hardware failures. With more electric vehicles deployed on roads equipped with high capacity batteries, the need to safely manage large format batteries in foreseeable hazardous conditions against malfunction becomes imminent. In this presentation we will adopt the methodology of ISO 26262 to assess whether a battery system achieves the state of a fail-safe system, which consists of subsystems that work together to detect a hazardous situation through sensors, react to that situation in a pre-determined way through logic, and get the system to an appropriate safe state through actuation. We will present case studies on how to assign an automotive safety integrity level via risk analysis and evaluate the safety function devices based on the safety goal and its application environment.

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Testing Tools and Methodologies for Lithium-ion Cell Qualification


Product Markings and Labels Richard Nute (IEEE Product Safety Engineering Society & Richard Nute Product Safety Consultant, USA)

Abstract: Product markings and labels provide information about the product, installation, and use. The markings and labels can also provide warnings to avoid hazardous energy transfer to a body part. The product safety aspects of markings for identification, ratings, functions, connections, and warnings are described.


EU REACH Update Michael Kirschner (Design Chain Associates, LLC, USA)

Abstract: While the continuous addition of declarable substances of very high concern (SVHCs) are expected to stop next year, the addition of lead in 2018 means that now just about every manufacturer of electronic finished goods must disclose per Article 33. The list of substances being restricted continues to grow and must be monitored for restrictions that will have an impact. And in 2021 manufacturers will have to disclose the presence of SVHCs to the European Chemicals Agency (ECHA). This presentation will cover REACH requirements for manufacturers and importers of electrical and electronic finished goods (and components), the relationship to RoHS, what to expect in the coming years and how to comply.


IEC 60601-1-12 Emergency Medical Services Standard (EMS) and Essential Performance



Risk Assessment for LVD and EMC Directives Patty Knudsen (Teradata Corporation, USA)

Abstract: The presentation is a basic overview of how to do a risk assessment for the LVD and EMC Directives.

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EU MDR Hazardous Substances in Medical Devices Geoffrey Bock (TUV Rheinland of North America, Inc., USA)

Abstract: EU/MDR 2017/745 Annex 1, Chapter II, Section 10.4.1 is the driving legislation behind restricting certain hazardous substances in materials for Medical Devices. Since this is a new requirement (demanding that materials do not contain more than 0.1% of the substances listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 that are classified as 'CMR' of category 1A or 1B), OEMs are having difficulty with their supply chain. Most suppliers do not have this information ready available. This presentation will discuss the requirement, the challenges in the supply chain and how to risk assess and test for the restrictive substances. In addition, RoHS II adding phthalates to the restrictive list and the new 192 SVHCs under REACH will be discussed.


International Standards - used for EV supply equipment for charging electric road vehicles

Tina Ding (TUV SUD)

Abstract: This presentation will provide a general overview of IEC standards been used for Evaluating AC/DC EV charging system, under this condition, it further Lists the standards used in Europe and North America; Lastly, this presentation will provide some other countries have adopted or drafted national standards for EV charging system and what those countries regulatory regulation are. In this presentation, it will also introduce the electrical code for some countries where electrical installation is required.


UN 38.3 Lithium Battery Transport Testing - Overview & Updates John Copeland (Energy Assurance LLC, USA)

Abstract: This presentation provides an overview of lithium battery transportation testing found in the UN Manual of Tests and Criteria, Section 38.3. Specifics will include some background on the test standard itself, a view of the individual test steps from the test lab perspective, and finally a look at the changes found in Amendment 1 to the Sixth Edition which became effective on January 1, 2019.


Global Regulatory Updates for Small Format Lithium-Ion Batteries and Power Banks

John Copeland (Energy Assurance LLC, USA)

Abstract: This presentation provides an overview of global regulatory compliance requirements for small format lithium-ion batteries and power banks updated for 2019 requirements.

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Middle East Countries Electronic Product Compliance Mark W. Maynard (American Certification Body, Inc. & Washington Laboratories, Ltd., USA)

Abstract: The Middle East area is an important market country for manufacturers seeking to expand globally. The majority are resource-rich in petroleum products, and the more affluent countries have extensive finance and banking companies. Many are upgrading their telecom and wireless infrastructure, and there is a large demand for ITE, wireless, and other modern electronic devices. This presentation provides an overview of the requirements for electronic product compliance for sixteen of these countries, including the product testing and submittal requirements, along with recommendations for a successful product certification project in each country.


My experience of Product Compliance - Motivation to change IEC standards Hiroshi Sasaki (IS-INOTEK, Japan)

Abstract: The products have to comply with the regulations and standards. The product compliance is sometime defensive and sometime offensive. I would like to explain how I have changed IEC standards in my experience. For the compliance management the human resources are most important. The product compliance on safety is always defensive. When the product does not comply, try to change the safety standard. In 2001 at IEC TC61 Kagoshima meeting, we asked to change the IEC safety standard for spin extractors. We achieved to change the standard allowing the opening distance from 10 mm to 50 mm. it took 7 years. This old style twin tub washing machines are widely used in Asian countries. In 2000 at Singapore, it was announced that this washing machine did not comply with IEC standard and not allowed to sell. Apparently this is defensive action. The activity on performance of refrigerator was offensive. EU made ISO standard and stopped modification to keep the energy labeling scheme unchanged. We changed standard in 2015 and US and all ASEAN countries will adopt the standard. It took 8 years to issue 2nd edition in IEC. Once in Japan ISO was adopted as JIS, the annual energy consumption was too low to the real energy consumption at home. This was claimed by the user of refrigerator. The new JIS introduced door open and close and load input during the energy consumption measurement. ISO standard specified full load of test load in the refrigerator but keep door closed. When the door opened and load input, the compressor worked hard to keep the inside at the low temperature, then the energy consumption would be increased. During 2006 and 2009, Japan made approach for the world, such as Asia Pacific Partnership refrigerator project, IEA meeting and workshop. My nickname became Mr. Open The Door. I always spoke the annual consumption of refrigerator while sleeting is always lower value that the value when the door of the refrigerator open and closed. During 2009 and 2015, Japan participated IEC SC59M and made approach for Asia. Almost all Japanese CEO and engineers believe that the regulations and standards to be given by the governors. I always believe that at least standards should be decided by engineers of the manufacturers. I believe the top runner manufacturer shall lead the industry by making the international standards. In order to realize this human resources are very important. The applicants to iNARTE PS engineer examinations are year by year increased. These engineers contribute to keep the products in compliance with the regulations and standards. These certified engineers take the key role in the management of product compliance. I would like to support the manufacturers to make the international standards to enhance the product compliance in the offensive activity. 55


Regulatory Updates E-Waste and Take Back Laws in Latin America Elizabeth Perrier (Product Regulatory Compliance- Latin America & Orbis Compliance LLC, USA)

Abstract: By 2022, 80% of all Latin American countries will have implemented e-waste and battery collection programs. This presentation will describe and review current e-waste regulations in Argentina, Brazil, Chile, Columbia, Paraguay, Peru and Mexico. This is an important subject for manufacturers to consider as these regulations will have long-term impacts on product importation and development of stewardship programs.


Assessment of a product to determine safe Electromagnetic Field (EMF) Exposure levels

Tom Tidwell (Nemko USA, Canada)

Abstract: A discussion of the current standards, test methods, and mathematical evaluation of Radio Frequency Electromagnetic Fields. How to evaluate a product to determine safe EMF levels.


Safe Design of Laser Consumer Products Erwin K Lau (Exponent, Inc., USA)

Abstract: In recent years, consumer products containing lasers are becoming increasingly more prevalent. For example, lasers used for environmental depth sensing or eye tracking have entered into mainstream consumer culture. Risks involving such products are increased due to a combination of purposeful intrabeam viewing and large populations of products (estimated at over 100 million devices globally). In order to protect the general consumer population, it is imperative to develop a safety program that is fully integrated within the product development lifecycle and that incorporates industry best practices. In this paper we propose a design-for-safety approach to product development that follows a rigorous safety design philosophy that can allow for optimization of both performance and safety.

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Don't Let Global Regulatory Compliance Negatively Impact Your Product's Reach Catherine Wong (SGS North America, USA)

Abstract: With the continuous growth of worldwide trading, regions, and even countries, have set up their own product conformity assessment systems to protect the public from unsafe products Due to these varying standards, a single product entering the market might be subjected to multiple compulsory conformity assessments. These requirements can cause significant delays and unexpected costs to companies as they are trying to get their products into designated markets. To avoid these kinds of delays, it is crucial to know country/region specific requirements and understand the risk of non-compliance. This presentation will not only examine the specific requirements, but also look at broader global regulatory trends that can affect where a product can be sold. This will include key countries' regulatory scope of safety, electromagnetic compatibility and radio equipment compliance. The importance of international product compliance can be understood, but the prospect of complying to a plethora of requirements can be a daunting task. Therefore, many product manufacturers choose a 3rd party testing and certification company to achieve global market access. Working with a qualified 3rd party lab can be a great solution to get your product into its chosen market without significant delays. To make this process seamless, there are some key points that you need to know to prevent avoidable delays and costs. Don't let global regulatory compliance negatively impact your product's reach.


EU RoHS 3: Are You Ready? Kenneth Stanvick (Intertek, USA)

Abstract: Background: Now that electronic manufacturers are getting comfortable with the EU RoHS Directive being under the CE Mark requirements, they will need to consider how four new phthalates will play into the mix. July 2019 officially marks the addition of new substances under this Directive and companies need to be prepared as it will offer an easy target for enforcement agencies. This presentation we will provide an overview of the EN50581 requirements (what you need in your CE file for RoHS) as well as what the addition of Phthalates means to manufacturers and where they should be concerned. We will also talk about some strategies that should be implemented to ensure you can meet your timeline for July 2019. Please note I presented last year in California.

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Documents

TABLE OF CONTENTS WELCOME MESSAGE 2 ISPCE 2019 … · Program and our Mentorship Program as well. interested in any of these technical activities? Please come. On Wednesday, we will