For full submission instructions, visit the SPCE 2019 website: https://2019.ieee-spce.org

Program for 2019 IEEE Symposium on Product Compliance Engineering (SPCE Austin)

Time Sabrio Shoal Creek Trinity Session

Monday, November 11

08:30 am-09:00 am Breakfast      
09:00 am-10:00 am   Compliance 101 The Basics of Product Safety And Regulatory Compliance India Certification Overview- BIS Safety and WPC Wireless  
10:00 am-10:30 am Morning Break, Exhibits and Networking      
10:30 am-11:30 am   Compliance 201 The basic Certification requirements for any Product International Standards used for EV Supply Equipment for Charging Electric Road Vehicles  
11:30 am-11:40 am       Transistion/Networking
11:40 am-12:40 pm   "Global Market Access" Worldwide market access for electrical products Global Regulatory Compliance Process and Navigation  
12:40 pm-02:10 pm Keynote: Grant Schmidbauer      
02:10 pm-03:10 pm   Risk Management Objectives for Distributed Development of Interoperable Medical Products Safety and EMC compliance with fabrication equipment in semiconductor industry: challenges and solutions  
03:10 pm-03:20 pm       Transistion/Networking
03:20 pm-04:20 pm   India TEC Certification Thermal Considerations for Information Technology Equipment from Product Safety Perspective  
04:20 pm-04:50 pm Afternoon Break, Exhibits and Networking      
04:50 pm-05:50 pm   Electric Shock, Compliance101 Standards for the Introduction of Accessible DC Power in Buildings  
05:50 pm-06:00 pm       Transistion/Networking
06:00 pm-07:00 pm   Chapter Meeting Modular Radio Approvals- Using transmitter modules  
07:00 pm-08:30 pm Monday Reception      

Tuesday, November 12

08:00 am-08:30 am Breakfast      
08:30 am-08:40 am       Transistion/Networking
08:40 am-09:40 am   A Hazard-Based Approach to Product Safety Assessment Certification Management Service  
09:40 am-09:50 am       Transistion/Networking
09:50 am-10:50 am   Why Products Fail Safety Testing Hazards of Human Exposure to Electromagnetic Fields  
10:50 am-11:20 am Morning Break, Exhibits and Networking      
11:20 am-12:20 pm   Arcing Persistency Measurement for IEC62606 Arc-Fault Detection Device Certification Wireless goes Global  
12:20 pm-01:20 pm Lunch, Exhibits and Networking      
01:20 pm-02:20 pm   Harmonization of IEC and EN 62368-series of standards Fifth Generation Wireless Technology  
02:20 pm-02:30 pm       Transistion/Networking
02:30 pm-03:30 pm   Regulatory changes in Saudi Arabia and South Africa Risk Analysis for the Radio Equipment Directive  
03:30 pm-04:00 pm Afternoon Break, Exhibits and Networking      
04:00 pm-05:00 pm   New changes to the Mexico/NOM process Global Certification of Devices with a Radio Interface  

Monday, November 11 8:30 - 9:00

Breakfast

Room: Sabrio

Monday, November 11 9:00 - 10:00

Compliance 101 The Basics of Product Safety And Regulatory Compliance

Room: Shoal Creek
Compliance 101 The Basics of Product Safety And Regulatory Compliance
John R Allen (Product Safety Consulting, Inc., USA)

India Certification Overview- BIS Safety and WPC Wireless

Room: Trinity
India Certification Overview- BIS Safety and WPC Wireless
Thomas Ha (G&M Compliance, Inc., USA)
General Overview of Product Certifications for India. Topics includes India BIS Safety and Wireless WPC Test Requirement and Certification Processes.

Monday, November 11 10:00 - 10:30

Morning Break, Exhibits and Networking

Room: Sabrio

Monday, November 11 10:30 - 11:30

Compliance 201 The basic Certification requirements for any Product

Room: Shoal Creek
Compliance 201 The basic Certification requirements for any Product
John R Allen (Product Safety Consulting, Inc., USA)

International Standards used for EV Supply Equipment for Charging Electric Road Vehicles

Room: Trinity
International Standards used for EV Supply Equipment for Charging Electric Road Vehicles
Tina Ding (TUV SUD, Canada)
This presentation gives an overview on the standards used for EV charging system in IEC, Europe, North America as well as other key countries such as China, Korea, Japan, Australia etc. It also includes country regulatory requirements for EV charging system need to comply before marketing in those countries.

Monday, November 11 11:30 - 11:40

Transistion/Networking

Monday, November 11 11:40 - 12:40

"Global Market Access" Worldwide market access for electrical products

Room: Shoal Creek
"Global Market Access" Worldwide market access for electrical products
Grant Schmidbauer (Nemko USA, Inc., USA)

Global Regulatory Compliance Process and Navigation

Room: Trinity
Global Regulatory Compliance Process and Navigation
Catherine Wong (SGS North America, USA)
With the continuous growth of worldwide trading, regions and countries have set up their own product conformity assessment systems to protect the public from unsafe products. Due to varying systems, 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 the product into its chosen market without significant delays. To make this process seamless, there are some key points that we need to know to prevent avoidable delays and costs.

Monday, November 11 12:40 - 2:10

Keynote: Grant Schmidbauer

Room: Sabrio
Digital transformation in the testing, inspection, and certification (TIC) industry
Grant Schmidbauer (Nemko USA, Inc., USA)
The world is currently undergoing a digital transformation with "industrial revolution 4.0". And with this, comes major changes to the testing, inspection and certification (TIC) industry. Such developments will affect how, where and when TIC services are provided. Digital transformation, and the specific technology trends driving the change in the TIC industry include smart sensors, cyber security, big data, connectivity, blockchain, automation, and virtual/augmented reality. Although the evolution of digital technologies has only just begun, it's clear that they will exert an enormous impact on the TIC industry as we know it today.

Monday, November 11 2:10 - 3:10

Risk Management Objectives for Distributed Development of Interoperable Medical Products

Room: Shoal Creek
Risk Management Objectives for Distributed Development of Interoperable Medical Products
John Hatcliff (Kansas State University, USA); Yi Zhang and Julian Goldman (Massachusetts General Hospital, USA)
Medical devices are increasingly being built using interoperability and platform approaches that enable devices and service components from different manufacturers to be combined flexibly into ``systems of systems'' to achieve integrated care-giving solutions that typically exceed the capabilities of stand-alone devices with reduced likelihood of medical errors. In these situations, the primary medical device domain tasks such as risk management are distributed across the organization boundaries of stakeholder organizations, each of who contributes components as well as development and assurance artifacts to establish the interoperable medical system and produce system assurance arguements. However, ISO 14971 -- the primary medical device risk management standard -- focuses on single-manufacturer monolithic device and hence cannot, without necessary auguments, effectively guide distributed risk management activities across stakeholders. In this paper, we provide a set of risk management objectives for distributed development and assurance of interoperable medical systems and components of such systems. These objectives can be seen as augmenting the requirements of ISO 14971 to be provide additional criteria for achieving safety and security in the presence of interoperability features and integration of components from multiple vendors. These objectives may be used as claims in assurance cases for interoperable medical products or may form the basis of requirements in emerging standards for safe and secure interoperability.

Safety and EMC compliance with fabrication equipment in semiconductor industry: challenges and solutions

Room: Trinity
Safety and EMC compliance with fabrication equipment in semiconductor industry: challenges and solutions
Shu-lun Mak (The Open University of Hong Kong, Hong Kong)
Every technical country is discussing the internet of thing technology (IoT). The IoT's major significant trend in recent years is the explosive growth of devices connected and controlled by the internet. Many technical news journalists like, Amy Nordrum, even say forecast of 50 billion devices by 2020 is outdated. The IoT involves extending internet connectivity beyond standards devices, such as desktops, laptops, smart phones and tablets, to any range of traditionally dumb or non-internet-enable physical devices and everyday objects. All these electronics devices are manufactured by semiconductor fabrication equipment. We should clearly understand the regulatory (safety and Electromagnetic compatibility (EMC)) requirement of advanced technological countries like European countries to this fabrication equipment. This fabrication equipment involves numerous high speed, high temperature, and high precision technology. This paper discusses the challenges of the newest European Union (EU) compliance requirement and propose a solid approaches that can be taken to bring a fabrication equipment to market successfully from a compliance perspective.

Monday, November 11 3:10 - 3:20

Transistion/Networking

Monday, November 11 3:20 - 4:20

India TEC Certification

Room: Shoal Creek
India TEC Certification
Monrad L Monsen (Oracle, USA)
India Telecommunications Electronics Centre (TEC) mandates TEC certification for six categories of telecommunications products starting 1 October 2019 ... and many more categories products will be regulated soon after. This presentation will give the latest information about TEC approvals, the test requirements, and the categories of products that will be impacted.

Thermal Considerations for Information Technology Equipment from Product Safety Perspective

Room: Trinity
Thermal Considerations for Information Technology Equipment from Product Safety Perspective
Shun Zhang (Cisco Systems, Inc., China); Yingchun Shu (CISCO, China); Daniel Barsotti and Gary Gray (Cisco Systems, Inc., USA)
Thermal consideration as one of the most significant factors from product safety discipline, it is related to cooling methods, ambient temperature, airflow, touch temperature for accessible parts, module power dissipation, and so on. This paper provides comprehensive perspectives to explores the thermal considerations which should be focused on the product safety compliance of information technology equipment, from theory analysis to practical implementations, from the design techniques to testing strategy. Some of the design techniques for thermal management are proposed, including DC fan and heatsink selections, some PCB design tips, and the design considerations for a fan-less system. Regarding test strategy, this paper demonstrates that the maximum loading for a system at maximum ambient temperature maybe not be as the worst case to represent the test result for some safety-critical components, especially for temperature-dependent equipment with smart fan, since the fan speed will be variable with the monitor or sensing temperature or loading condition. Therefore, test engineers need to understand these related designs, including the key components to be monitored, the over-temperature protection mechanism, the algorithm of fan speed and so on. This paper also discusses the requirements from existing product safety standards, including IEC 60950-1 and IEC 62368-1. At the end of this paper, liquid cooling solutions for information technology equipment has also been discussed from a product safety perspective; the considerations should be different for liquid filled heat-sink system and insulating liquid immersion cooling system.

Monday, November 11 4:20 - 4:50

Afternoon Break, Exhibits and Networking

Room: Sabrio

Monday, November 11 4:50 - 5:50

Electric Shock, Compliance101

Room: Shoal Creek
Electric Shock, Compliance101
Peter Perkins (P. E. Perkins PE, USA)
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.

Standards for the Introduction of Accessible DC Power in Buildings

Room: Trinity
Standards for the Introduction of Accessible DC Power in Buildings
Jake Staples (Carleton University & ESAFE Product Approval Service, Canada); Jacques Martin (Electrical Safety Authority, Canada); Sreeraman Rajan (Carleton University, Canada)
With the increasing need for the local generation of renewable energy that use DC sources, along with load demands changing to low wattage DC electronics, LED lights and DC motors in appliances, the ongoing suitability of the AC distribution grid must be challenged. Furthermore, alternatives to the unnecessarily hazardous in-home AC voltages must be considered. Establishing DC micro-grids can make the world a safer, more sustainable place to live and provide a framework for further advances to be made toward a more efficient and renewably compatible world. Currently, a lack of standards exists relating to the configurations of DC plugs, receptacles and nominal voltage levels, preventing manufacturers and consumers from being able to plug DC electronics and appliances directly into a DC source like a renewable energy system or a micro-grid. Standards to regulate the configurations and power output of DC plugs and receptacles would introduce a compatibility between these DC sources and the expanding prevalence of DC loads. The reception of these standards could influence the locally generated renewable energy market, which could lead to the development of more sustainable DC micro-grids able to power all DC loads from cell phones to electric vehicles.

Monday, November 11 5:50 - 6:00

Transistion/Networking

Monday, November 11 6:00 - 7:00

Chapter Meeting

Room: Shoal Creek

Modular Radio Approvals- Using transmitter modules

Room: Trinity
Modular Radio Approvals- Using transmitter modules
Michelle Furrow (Nemko USA, Inc., USA)

Monday, November 11 7:00 - 8:30

Monday Reception

Room: Sabrio

Tuesday, November 12 8:00 - 8:30

Breakfast

Room: Sabrio

Tuesday, November 12 8:30 - 8:40

Transistion/Networking

Tuesday, November 12 8:40 - 9:40

A Hazard-Based Approach to Product Safety Assessment

Room: Shoal Creek
A Hazard-Based Approach to Product Safety Assessment
Sneha Lele and Michelle L Kuykendal (Exponent, Inc., USA)
The principle of safety standards is to protect users from injury or death caused by electrical shock, chemical exposure, fire, and radiation, to name a few. There are numerous national and international standards that include safety specifications to guide the design and manufacture of safe products. In this paper, we discuss a new standard IEC 62368-1 that keeps pace with new products and emerging technology while accommodating legacy components. The intent of this standard is to identify potential safety hazards during the design stage to enable better control and mitigation of foreseeable risks. Although this standard is practical in the way that it addresses hazard-based safety design, it does not preclude a complete durability and performance testing to evaluate a product.

Certification Management Service

Room: Trinity
Certification Management Service
Thomas Ha (G&M Compliance, Inc., USA)
Product Compliance does not start with a prototype, nor does it end with a certificate. Rather compliance is a continuous process that begins in the early stages of the product design, peaks during certification, and continues to be maintained through the life of a product. This presentation will focus on the best practices used to manage product certification of products.

Tuesday, November 12 9:40 - 9:50

Transistion/Networking

Tuesday, November 12 9:50 - 10:50

Why Products Fail Safety Testing

Room: Shoal Creek
Why Products Fail Safety Testing
Richard K Covell (Bureau Veritas, USA)
Nearly every product that goes to a test lab fails on the first attempt. This can add expense and delays to a product launch cycle. This presentation identifies some of the most common errors that are found during a product evaluation. Key concepts that are universal among all electrical product safety standards are discussed. This presentation will provide a technical overview regarding product design, testing and documentation requirements.

Hazards of Human Exposure to Electromagnetic Fields

Room: Trinity
Hazards of Human Exposure to Electromagnetic Fields
Tom Tidwell (Nemko USA, Canada)
This presentation will define and examine the risks of exposure to electromagnetic fields for humans and domestic animals. The short and long-term effects will be discussed as well as accepted techniques for quantifying and mitigating exposure.

Tuesday, November 12 10:50 - 11:20

Morning Break, Exhibits and Networking

Room: Sabrio

Tuesday, November 12 11:20 - 12:20

Arcing Persistency Measurement for IEC62606 Arc-Fault Detection Device Certification

Room: Shoal Creek
Arcing Persistency Measurement for IEC62606 Arc-Fault Detection Device Certification
Arc Fault Detection Devices (AFDD's) or Arc Fault Circuit Interrupters (AFCI's) are mandatory electrical protection devices in panel boards all over the world, to mitigate the risk of fire due to hazardous electrical arc faults. By its nature, the arc fault is an erratic phenomenon, with variable temporal persistency and variable ability to ignite a fire. The two main standards for AFDD certification are UL1699 & IEC62606, which require similar arcing tests. However, there is no current requirement for a minimal arcing persistency during a standard series arc test, neither a clear guideline on how to measure the arcing temporal persistency and confirm the test yielded a successful series arc fault. This work aims to enhance the standards, by proposing a simple method to precisely determine the arcing persistency during a series arc fault test. Using only the arc current and arc voltage as inputs, a standard series arc signal can be accepted or rejected, based on the measured level of temporal arcing persistency.

Wireless goes Global

Room: Trinity
Wireless goes Global
Theresa Glenna (TUV SUD America Inc., USA)
In this presentation we will discuss several options for integrating wireless into a product and the pros and cons of using preapproved modules. Attendees will gain valuable insight on choosing a wireless module and how to prepare for testing. We will take a closer look at the wireless regulatory requirements in 30 of the most common countries across the globe.

Tuesday, November 12 12:20 - 1:20

Lunch, Exhibits and Networking

Room: Sabrio

Tuesday, November 12 1:20 - 2:20

Harmonization of IEC and EN 62368-series of standards

Room: Shoal Creek
Harmonization of IEC and EN 62368-series of standards
Grant Schmidbauer (Nemko USA, Inc., USA)
This presentation will discuss the current market situation in Europe related to the latest edition of the standard EN 62368-1. With the introduction of the European Commission HAS (Harmonized standard) consultant, the publication of harmonized EN standards with the hope of eventual citing of the harmonized standard in the Official Journal of the LVD has seen significant delays. This presentation will untangle, as best as possible, the current situation related to the latest edition of EN 62368-1, and include time for Q&A.

Fifth Generation Wireless Technology

Room: Trinity
Fifth Generation Wireless Technology
Tom Tidwell (Nemko USA, Canada)
This presentation will explore the next generation of wireless network technology. As the demand for faster, more robust, and higher capacity networks has grown, 5G standards have been developed to meet the demand. We will discuss the rollout of new networks and the details of new wireless technologies. Further wee will examine the impacts of these advancements on test and certification procedures.

Tuesday, November 12 2:20 - 2:30

Transistion/Networking

Tuesday, November 12 2:30 - 3:30

Regulatory changes in Saudi Arabia and South Africa

Room: Shoal Creek
Regulatory changes in Saudi Arabia and South Africa
Theresa Glenna (TUV SUD America Inc., USA)
A closer look at the new SALEEM/SABER scheme in Saudi Arabia and the SABS requirements for EMC testing in South Africa

Risk Analysis for the Radio Equipment Directive

Room: Trinity
Risk Analysis for the Radio Equipment Directive
Tom Tidwell (Nemko USA, Canada)
This presentation presents practical advice on performing a risk analysis to satisfy the requirements of the EU Radio Equipment Directive.

Tuesday, November 12 3:30 - 4:00

Afternoon Break, Exhibits and Networking

Room: Sabrio

Tuesday, November 12 4:00 - 5:00

New changes to the Mexico/NOM process

Room: Shoal Creek
New changes to the Mexico/NOM process
Grant Schmidbauer (Nemko USA, Inc., USA)
Effective June 2019, there has been significant changes to the market access conditions for products going into Mexico. This presentation will debug the process and present the new requirements. The presentation time slot will also have time for Q&A as required.

Global Certification of Devices with a Radio Interface

Room: Trinity
Global Certification of Devices with a Radio Interface
Michelle Furrow (Nemko USA, Inc., USA)