SSSD 2019 Program

Grant Schmidbauer

Grant Schmidbauer is Sr. Vice President, Region North America, in the Nemko Group, and the President of Nemko North America, Inc., and Nemko USA, Inc.  

Grant has more than 35 years of experience in the field of International Product Compliance and Global Market Access. 
Grant has served on the Board of Directors of the IEEE/PSES, participating as BoD member-at-large

Topic: Digital transformation in the testing, inspection, and certification (TIC) industry

Keynote

Kevin Tang is a staff engineer and has been with UL for 30 years. He has served in various roles ranging from project handler, reviewer, technical advisor, primary designated engineer for several categories and course development for UL University. Among the standards that Tang has worked on are batteries, cells, ITE, audio/video equipment, modular data centers, medical equipment and telecom. He was part of the task force that developed training courses for small and medium format batterie and IEC/UL 62368-1 Annex M (ITE Equipment using batteries). He is the West Coast small format battery subject matter expert for UL

Medical Track & Other

Title: Medical Devices, the Need for Better Biosensors and Bio-tools

‚ÄčA vision of improving medical care by performing reliability analysis and identifying and using biochemical (predictive and diagnostic), biomechanical, sensor information and imaging data for patient care - including molecular pathology, laboratory diagnostics (clinical chemistry - DNA) and medical diagnostic imaging:  Including 1. Implementation/Integration of Electronic Health Records and personalized Health Records 2. Standards harmonization, conformance testing, and certification of operators for the complex medical equipment, and 3. Detailed mathematical modeling and computational analysis. 

Author: Richard (Dick) Doyle, Past President of the IEEE Reliability Society

Richard Doyle has over 40 years of experience in the theoretical analysis and design of electrical and mechanical systems including: Consulting for the past 30 years in Aerospace, in Commercial Electronics, and Nuclear Power Industries. Mr. Doyle is a former president of the IEEE Reliability Society. Mr. Doyle wrote in Chapters 18, 19 and 20 for Handbook of Reliability Engineering and Management By: Doyle, Richard L, Published in 1996. He also wrote in Chapters 3.1 and 3.3 through 3.5 of the Standard Handbook of Electronic Engineering, Fifth Ed, Published in 2005. He also has written hundreds of reports and studies associated with the seismic qualification of nuclear instruments in nuclear power plants

Title: Emergency Medical Services - IEC 60601-1-12

This presentation will identify key elements covered for ME equipment to comply with IEC 60601-1-12 standard. 

Author: Shripal Pandya, CSA Group

Shripal Pandya has more than 10 years of experience working with Medical Devices – IEC 60601-1 standards and Lab/Measurement products – IEC 61010-1 standards. He has worked several on certification projects throughout in his career including product such as Infusion pumps, Lung ventilators, Oxygen Concentrators. He is currently working as a Technical Specialist at CSA Group in Irvine, CA. Shripal has Master’s degree in Engineering from San Jose state University.

Title: Safe, Effective & Secure Service-oriented Device Connectivity for High-Acuity Healthcare Environments

Author: Todd Cooper, Trusted Solutions Foundry, Inc.

Todd Cooper is an international expert in the area of medical device informatics and healthcare data exchange. A key focus of Todd’s efforts has been to establish “interoperability trust” – a high level of confidence that interoperable technologies will perform as expected, safely and securely. Todd has spent over 30 years focused on the challenges of medical device interoperability, especially infusion pumps, ventilators and physiologic monitors and has also been actively involved in advancing standards-based solutions for healthcare exchange, playing key leadership roles within numerous standards development and advocacy groups, including ISO/TC 215 (Head of the U.S. Delegation), IEEE EMBS/11073, Health Level Seven (HL7) and Integrating the Healthcare Enterprise (IHE).  He is a member of the American College of Clinical Engineers and a recipient of awards such as the 2014 IEEE Standards Association Lifetime Achievement award, the 2009 ACCE-HIMSS Excellence in Clinical Engineering and Information Technology Synergies Award.  Todd launched the HL7 Devices on FHIR initiative in 2016 and serves on the FHIR Foundation Board.  As convener of ISO/IEC JWG7, he helped lead the development of the IEC/ISO 80001 standards and related projects such as 62304 2nd edition and 82304-1 for health software quality.

Title: Current Trends in Electromedical Equipment Standards

Major advances in medical technologies over the last few decades have contributed to early diagnosis of disease, more efficient delivery of treatment and longer, healthier lives. From switches to swipes, from hardware to apps, or from the hospital home environment, healthcare device has continued to undergo a paradigm shift. To keep up with these advances, and to compete in a highly competitive and complex market, healthcare system 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 personnel 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 electronic medical equipment standards as it relates to EC slash ISO 6061 series of standard including an introduction to the history of medical robot and future continuation medical robotic applications. Upon completion, participants will enhance their knowledge in following curious basics 15 essential performance requirements for electromagnetic equipment, medical robotic definitions and applications. 

Author: Shripal Pandya, CSA Group

Shripal Pandya has more than 10 years of experience working with Medical Devices – IEC 60601-1 standards and Lab/Measurement products – IEC 61010-1 standards. He has worked several on certification projects throughout in his career including product such as Infusion pumps, Lung ventilators, Oxygen Concentrators. He is currently working as a Technical Specialist at CSA Group in Irvine, CA. Shripal has Master’s degree in Engineering from San Jose state University

Title: Mexico Market Access and Regulations

This presentation will discuss the Regulatory requirements in Mexico, Trade, Standards and Conformity Assessment Bodies, Standards (NOM and NMX) and will provide an overview of Mexico Safety Scheme, Safety Approval Schemes and Approval Procedures and Processes. 

Author: Grant Schmidbauer, Nemko USA

Grant has more than 35 years of experience in the field of International Product Compliance and Global Market Access. 
Employment includes CSA (11 years), TUV Product Service (2 years) and Nemko (23+ years).
Graduate from the British Columbia Institute of Technology (BCIT), Vancouver BC, in Power Electronics, then started his career in the field of International Product Compliance soon after. 
Grant is the Sr. Vice President, Region North America, in the Nemko Group, and the President of Nemko North America, Inc., and Nemko USA, Inc.  
Grant has also served on the Board of Directors of the PSES, participating as BoD member-at-large

Title: An alternative to certification (kind of), Field Evaluation (USA) and Special Inspection (Canada) 

Author: Phil Meadow, Nemko USA

Phil Meadow has more than twenty years of experience in the NRTL and FEB arena.  Experience began with AGA Laboratories, and continued with CSA Group, eti Conformity Services, and is presently employed as the Field Evaluation Program Manager for Nemko USA.  Educational background includes a bachelor’s degree from the University of Illinois in Urbana/Champaign, and MBA from Pepperdine University

ITE Track

Title: Compliance 101

The intent of this presentation is to provide a basic knowledge of Product Safety and Regulatory Compliance for products sold worldwide.

  • The presentation covers the requirements for those involved in new and existing products and those who need to address global safety requirements.

  • This training will provide the fundamental guidance for product safety which can support geographic sales for import and export around the world.

Author: John Allen, Product Safety Consulting

John Allen is the Founder and President of Product Safety Consulting. Over the last 33 years John has obtained worldwide Certifications on a diverse list of product categories including lighting, consumer electronics, small and large electrics, medical, industrial controls, machinery, gas appliances, Robotics, ITE and many more. John also has been doing Hazard Analysis and Risk Assessments for over 15 years and serves as a senior advisor on product safety to a number of global companies.  John is also deeply involved in the Institute of Electrical and Electronic Engineers (IEEE) Product Safety Engineering Society (PSES) since 1985. He is Past Chair of the PSES Chicago Chapter, Chairman of the PSES Risk Assessment Technical Committee, past Chair for the PSES’s flagship Symposium ISPCE 2015, has held various positions on the Board of Governors and is now President of the IEEE Product Safety Engineering Society. The Mission of the IEEE’s PSES is to transfer knowledge to Designers and Compliance Engineers and make it easy to understand.  John often speaks on product Safety and Certifications to various Trade Associations and Chamber of Commerce and various IEEE Conferences

Title: Compliance 201

This presentation is a continuation of presentation #1 (covering Product Safety and Regulatory Compliance for products sold worldwide), looking into the requirements in more detail.

  • We will review requirements in product safety standards and the impact to new designs.

  • Understanding the level of product safety testing in accordance with safety standards will also be covered.

  • We will discuss product safety risks (Electrical, Mechanical, Lasers, Radiation, etc.) and methods to mitigate risk and ensure compliance.

  • ‘Design For Compliance’ techniques will be discussed as they pertain to complying with global product safety standards (UL, CSA, IEC).

  • Maintaining compliance through product modifications will be included.

  • Challenges and best practices will be shared that will help product designers get a new product to market quickly and efficiently.

Author: John Allen, Product Safety Consulting

John Allen is the Founder and President of Product Safety Consulting.

President of the IEEE Product Safety Engineering Society. The Mission of the IEEE’s PSES is to transfer knowledge to Designers and Compliance Engineers and make it easy to understand.  John often speaks on product Safety and Certifications to various Trade Associations and Chamber of Commerce and various IEEE Conferences

Title: Global Market Access

Once your product complies with (all) the regulatory requirements for the different countries you plan to market the product, you must then obtain the necessary country approvals.

  • This presentation will provide an overview of global market access requirements, and then give more specific requirements for North America, European Union, and some of the other Asian and South American countries.

Author: Grant Schmidbauer, Nemko USA

Grant Schmidbaueris the Sr. Vice President, Region North America, in the Nemko Group, and the President of Nemko North America, Inc., and Nemko USA, Inc.  
Grant has also served on the Board of Directors of the PSES, participating as BoD member-at-large

Title: IEC 62368-1:2018 (3rd Ed.) Key Considerations and Challenges

The IEC 62368-1 is a totally new standard based on Hazard Based Safety Engineering principals thus, this presentation will provide an overview of major differences between IEC 60950-1 and IEC 62368-1 and discuss key considerations and challenges of IEC 62368-1.

Author: Leszek Langiewicz, HP Inc.

Leszek Langiewicz has over 35 years of experience in Power Supply Design, Regulatory Compliance, Product Safety, EMC, Telecom, Low Power Management for consumer, commercial and telecom products.  
Since 2005 with HP Inc. as Regulatory Program Manager responsible for products worldwide compliance.  
Member of USTAG for IEC/TC108, ANSI, UL THC 62368-1.  
IEEE Senior member and ISPCE Technical Program Committee (TPC) Co-Chair.
Co-founder and co-chair of IEEE PSES San Diego Chapter

Title: IEC TR 62368-2: How the ‘Rationale Document’ for IEC 62368-1 Assists in the Timely Understanding & Application of the Hazard-Based Standard

One of the key objectives of IEC TC108 when their efforts began to develop a new hazard-based standard in the early 2000’s was that a record be kept of the origin, basis for, and rationale for the requirements in the new standard, IEC 62368-1, Audio/video, information and communication technology equipment - Part 1: Safety requirements.  This was considered important since history has demonstrated that over time, as standards continue to be used, and original committee members no longer are involved, the rationale behind why requirements are in a Standard often are lost, which makes understanding and refining the requirements more difficult over the long term.  Therefore, IEC TC108 documented the rationale behind the adopted requirements in IEC 62368-1, which eventually resulted in the publication of a Technical Report, IEC TR 62368-2, Audio/video, information and communication technology equipment - Part 2: Explanatory information related to IEC 62368-1.  Although the TR is a critical accompaniment to IEC 62368-1, often users of the 62368-1 standard don’t realize this ‘rationale document’ exists, or don’t use it to their advantage, both from a knowledge and learning perspective, and as a source to drive practical application.  This presentation will review the origin of the TR, its structure, some interesting key areas that users should be aware of, and how this document can be used to understand and apply the IEC 62368-1 Standard

Author: Jerry Dikun, UL LLC

Jerry Dikun, Engineering Project Lead, UL Fremont, CA, CTECH Division
Jerry has been with UL for 31 years. He has served in various roles including product evaluations to IEC 62368 Audio / Video, Information and Communications Technology Equipment, IEC 60950 Information Technology Equipment, IEC 60065 Audio Video Equipment, UL22 / CSA 60335 Part 2-82 Amusement and Gaming Machines.  Jerry is a Seminar Instructor for the UL Course: Designing for Compliance to IEC 62368-1, Third Edition

Title: EN 62368-1 harmonization in EU

This presentation will talk about recent position of EU HAS consultants on CENELEC standards and its impact on standards harmonization.

Author: Grant Schmidbauer, Nemko USA

Grant Schmidbauer is the Sr. Vice President, Region North America, in the Nemko Group, and the President of Nemko North America, Inc., and Nemko USA, Inc.  
Grant has also served on the Board of Directors of the PSES, participating as BoD member-at-large

 


Battery Track & Other

Title: Principles of Safety for Battery Operated Products

With battery technologies enabling devices that promote mobility, convenience, and innovation for consumers, there has been a rapid and steady emergence of products where battery and its end device design elements have become critical for defining safe use and operation. UL has pursued to look at these devices, and with their public safety mission in mind, have developed industry standards that promote safer design practices. This presentation will cover a few of those examples

Author: Kevin Tang, UL LLC

Title: Battery requirements according to 62368-1 annex M 

As IEC 62368-1 moves closer to full implementation globally, there still remain misunderstandings on component battery and BMS (Battery Management System) requirements.  Many ITE and AV devices have replaced battery “packs” with integrated batteries(cells directly connected to the device), or have adopted a system level approach to protecting cells and batteries, especially for Lithium Ion types.  Due to these changes in design and the standard itself, from IEC 60950-1, it is critical to understand the limitations of component battery certifications to UL or IEC battery standards, as well as how to apply these requirements when evaluating the battery and protection circuits as part of the overall device.  In this presentation, we discuss the battery and BMS requirements of 62368-1, Annex M, as well as comparing, contrasting, and interpreting the component battery and cell certifications, to understand what is truly required to demonstrate compliance to the standard

Author: Rich Byczek, Intertek

Rich Byczek is the Global Technical Director for Transportation Technologies at Intertek. He has over 20 years of experience in product development and validation testing, 15 of which have been spent at Intertek. Rich is experienced in the areas of energy storage, audio equipment and EMC testing. Rich sits on several SAE, IEC, UL and ANSI standards panels, focusing on Energy Storage and Electric Vehicle Technologies.  He holds a Bachelor of Science in Electrical Engineering from Lawrence Technological University in Southfield, Michigan, and is based at the Intertek facility located in Plymouth, Michigan

Title: Presentation on Li-ion Battery Safety

This presentation will highlight the fire safety problems with large-scale stationary Li-ion battery deployments, the Codes and Standards that have been developed in response to these problems, and the steps the industry is taking to improve safety, including via alternative chemistries.

Author: Curtis Ashton, American Power Systems

Curtis Ashton has 27 years of experience in telecommunications powering and grounding, 4 years of experience in electric utility power generation, and recently moved to a DC services company that is part of a large battery manufacturer, as their Director of Training.  He is the present chair of the IEEE PES (Power and Energy Society) ESSB (Energy Storage and Stationary Battery Committee), and serves as chair of 2 of its working group, as well as a vice-chair or secretary of several other working groups.  He also served a term on the IEEE Standards Association RevCom (Standards Review Committee), and is active in his local (Denver) PES-IAS chapter.  He formerly served as the vice-president of IEEE PELS (Power Electronics Society) TC (Technical Committee) 7 (Intelec – International Telecommunications annual Energy Conference). He is also the chair of the Battcon (an annual Battery conference) Technical Committee. He has a BSEE degree summa cum laude from Arizona State University.  He previously served as the vice-chair of ATIS (Alliance for Telecom Industry Solutions) STEP (Sustainability in Telecom Energy and Protection) standards subcommittees.  Mr. Ashton has been published and has presented numerous times at various conferences around the world.

Title: LATEST UN 38.3 FAQS & INTERPRETATIONS, UPDATES FOR 2019-2020 

This presentation discusses FAQS & Interpretations of lithium battery transportation testing requirements of UN 38.3 including updates for 2019-2020.

Author: Rich Byczek, Intertek

Rich Byczek is the Global Technical Director for Transportation Technologies at Intertek. He has over 20 years of experience in product development and validation testing, 15 of which have been spent at Intertek. Rich is experienced in the areas of energy storage, audio equipment and EMC testing. Rich sits on several SAE, IEC, UL and ANSI standards panels, focusing on Energy Storage and Electric Vehicle Technologies.  He holds a Bachelor of Science in Electrical Engineering from Lawrence Technological University in Southfield, Michigan, and is based at the Intertek facility located in Plymouth, Michigan

Title: Risk assessment for LVD, EMCD, RED 

Author: Patty Knudsen, Teradata Corporation

Patty Knudsen has worked in the compliance industry for over 30 years, working with ITE, machinery, household, laboratory, telecommunications, and medical equipment.  In addition to industry work, she was at TUV Rheinland of North America for six years.

Title: IEEE PES ESSB Safety Activities

 Author: Curtis Ashton, American Power Systems

Curtis Ashton has 27 years of experience in telecommunications powering and grounding, 4 years of experience in electric utility power generation, and recently moved to a DC services company that is part of a large battery manufacturer, as their Director of Training.  He is the present chair of the IEEE PES (Power and Energy Society) ESSB (Energy Storage and Stationary Battery Committee), and serves as chair of 2 of its working group, as well as a vice-chair or secretary of several other working groups.  He also served a term on the IEEE Standards Association RevCom (Standards Review Committee), and is active in his local (Denver) PES-IAS chapter.  He formerly served as the vice-president of IEEE PELS (Power Electronics Society) TC (Technical Committee) 7 (Intelec – International Telecommunications annual Energy Conference). He is also the chair of the Battcon (an annual Battery conference) Technical Committee. He has a BSEE degree summa cum laude from Arizona State University.  He previously served as the vice-chair of ATIS (Alliance for Telecom Industry Solutions) STEP (Sustainability in Telecom Energy and Protection) standards subcommittees.  Mr. Ashton has been published and has presented numerous times at various conferences around the world.

SSSD Submittal Instructions

1.   Presentation Submittal Deadline: Sep 8, 2019 

      to be send via email directly to SSSD Track Chairs; 

      - ME Track Chair Fabio Furlan 

      - ITE/Battery Track Chair - Grant Schmidbauer  

2.   Acceptance Notification Deadline: Sep 15, 2019 

3.   Register on-line to SSSD: Note that all participants are required to register (and pay) for the SSSD event, including all presenters and volunteers.

4.   Final Presentation Submission Deadline: Sep 28, 2019

       Presentation on the SSSD template