In Compliance: The Compliance Information Resource for Electrical Engineers logo
Product Regulatory Compliance:
Definition, Scope, Importance, and Impact
PLUS
High-Integrity Components in
Electrical Equipment, Part 1

Safety Programs and
CPSC Mandates

Contact Burn Injuries:
The Influence of Object Shape, Size, Contact Resistance, and Applied Heat Flux

digital connect the dots blue check mark
PLUS
High-Integrity Components in
Electrical Equipment, Part 1

Safety Programs and
CPSC Mandates

Contact Burn Injuries:
The Influence of Object Shape, Size, Contact Resistance, and Applied Heat Flux

May 2022
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May 2022
Volume 14 l Number 5
Contents
By Thomas Killam and Cyril Mecwan
Product regulatory compliance is a formal discipline that addresses every aspect of the product lifecycle, helping to ensure global acceptance of new and innovative technologies that are environmentally sound and safe to use.
By Steli Loznen
While the selection of components in electrical equipment plays a crucial role, a sound understanding of the characteristics of safety-critical and high-integrity components can provide valuable information about the ways to advance and achieve the safety goals.
By Kenneth Ross
Safety management programs are necessary to help a company make safe products and monitor safety for products in use. The CPSC has provided lots of guidances and mandates over the years on what constitutes an adequate program. These guidances are potentially useful to those companies seeking to establish a CPSC-compliant safety program and should be considered as part of the program development process.
The Influence of Object Shape, Size, Contact Resistance, and Applied Heat Flux
By May Yen, Francesco Colella, Harri Kytomaa, Boyd Allin, and Alex Ockfen
This is the second of a two-part series that discusses a numerical methodology that relies on the concept of cumulative equivalent exposure to evaluate contact burn injury thresholds.
man drawing a white chart with arrows on a clear board
digital illustration of inside electrical equipment
hands writing on a clipboard
hazard sign for a burn
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columns contributors
EMC Concepts Explained
Bogdan Adamczyk
adamczyb@gvsu.edu

Hot Topics in ESD
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compliance news
FCC Expands List of Communications Equipment That Pose Security Threat
The U.S. Federal Communications Commission (FCC) has added additional products to its list of communications equipment and services that are deemed to pose a risk to U.S. national security or U.S. citizens.

According to a Public Notice, the Commission’s Public Safety and Homeland Security Bureau has added the following equipment or services to its “Covered List” under the Secure and Trusted Communications Networks Act of 2019:…

EU Commission Initiates Public Consultation on RoHS
The Commission of the European Union (EU) has launched a public consultation on the EU’s Directive on the use of certain hazardous substances in electrical and electronic equipment to solicit input on potential changes to improve this landmark legislation.

The consultation seeks input on Directive 2011/65/EU (also known as the RoHS Directive) specific to…

DILBERT Comic strip
DILBERT © 2022 Scott Adams. Used By permission of ANDREWS MCMEEL SYNDICATION. All rights reserved.
Feature Article
Product Regulatory Compliance:
Definition, Scope, Importance, and Impact
A Rigorous Process to Achieve Core and Global Market Access
By Thomas Killam and Cyril Mecwan
man with marker looking at chart
A

ccording to the U.S. Consumer Product Safety Commission (CPSC), at least 41 Americans were killed and about 133,000 injured between 2017 and 2019 in incidents tied to e-scooters, e-bikes, and hoverboards.1 Ten companies were forced to recall approximately 500,000 hoverboards after the CPSC received about 100 reports of the lithium-ion battery packs that power hoverboards overheating, sparking, smoking, catching fire, or exploding.2

While these examples may represent a small segment of concern, their occurrence highlights the importance of product regulatory compliance and the consequences of failing to integrate compliance considerations into the design, development, production, and distribution of a wide range of products.

Background and Definitions
The world is full of regulations. Local, state, national, and international jurisdictions have in place a variety of regulations and regulatory compliance requirements addressing user safety and health, energy use, environmental issues, and other product-related considerations.
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Feature Article
High-Integrity Components in Electrical Equipment, Part 1
Achieving Safety Integrity Through the Selection of Components
By Steli Loznen
digital illustration of inside electrical equipment
I

n today’s increasingly complex and competitive world, the compliance and safety of electrical equipment have become a top management challenge for fulfilling all of the demanding regulations.

The safety of electrical equipment raises an important question, who is responsible for prioritizing safety above all when equipment is designed, implemented in production, installed, operated, and maintained? Manufacturing “safe” equipment has come to be a catchphrase, affecting and influencing the minds of many designers and manufacturers. But this is no longer enough. Instead, building a safety culture at the organizational and professional levels has become a must.

The present article (Part 1 of a two-part series), is intended to make a small contribution toward this goal of building a safety culture around electrical equipment.

Feature Article
Safety Programs and CPSC Mandates
Some Best Practices for Product Safety Management
By Kenneth Ross
Writing on paper clipboard
S

ince its inception in the early 1970s, the U.S. Consumer Product Safety Commission (CPSC) has encouraged companies to implement active product safety management programs. This article will examine the CPSC’s previous guidances on safety programs, describe the requirements imposed on companies, and discuss what they might mean.

These guidances and mandates are important since they can help a company determine if its safety program would be deemed sufficient by the CPSC or even by a jury in a product liability case and help identify areas where its program could be improved.

Prior Guidance on Safety Programs
The CPSC first published the Handbook for Manufacturing Safer Consumer Products in the 1970s, shortly after the CPSC was created. The last edition of this Handbook came out in 2006 and discusses product safety policies, organization, and training as well as all aspects of design, manufacturing, quality, corrective actions, etc. In other words, it discusses safety procedures that it believes are appropriate for any company making consumer products in all aspects of design, production, sales, and post-sale.
Feature Article
Contact Burn Injuries, Part II
The Influence of Object Shape, Size, Contact Resistance, and Applied Heat Flux
By May Yen, Francesco Colella, Harri Kytomaa, Boyd Allin, and Alex Ockfen
Contact burn warning sign illustration

Editor’s Note: The paper on which this article is based was originally presented at the 2020 IEEE International Symposium on Product Safety Engineering held virtually in November 2020. It is reprinted here with the gracious permission of the IEEE. Copyright 2020, IEEE.

Part I of this paper, “Contact Burn Injuries: Part I: The Influence of Object Thermal Mass,” was reprinted in the May 2021 issue of In Compliance Magazine and is available at https://incompliancemag.com/article/contact-burn-injuries-the-influence-of-object-thermal-mass.

Introduction

Part I of this series discussed the general aspects of the regulatory guidance for burn threshold surface temperature and contact duration limits [1,2,3]. Part 1 also outlined a number of important aspects associated with the regulatory framework. Specifically, the ISO 13732 standard assumes that the surface temperature of the object remains constant after contact with the tissue. The ASTM standard recognizes that there exists a difference between the object surface temperature, the object-skin interface temperature, and skin contact temperature, which is defined as the temperature at the epidermis-dermis interface. All the standards assume the surface temperature of the touched object remains constant and neglect the surface temperature reduction associated with the transfer of energy from the object to the tissues. Furthermore, only a limited number of contact parameters are considered in the standard. They include the thermal resistance between the heat source and surface of the device and the influence of the surface finish and material.

EMC concepts explained
Evaluation of PCB Design Options on Analog Signal RF Immunity using a Multilayer PCB
By Bogdan Adamczyk, Scott Mee, and Bilguun Baatar
T

his is the first of three articles devoted to the design, test, and electromagnetic compatibility (EMC) immunity evaluation of multilayer PCBs containing analog circuitry. In this study, there are seven design variants that all contain a similar schematic but implement different PCB layout techniques.

All variants were equipped with an analog voltage measurement along with a temperature measurement [1]. Non-conductive and metallic enclosures were evaluated for cases where the design options showed susceptibility issues. Testing was performed according to the ISO11452-11 Radiated Immunity Reverberation Method standard from 200MHz – 1GHz up to 100V/m and ISO11452-4 Bulk Current Injection from 1MHz – 400MHz up to severity level 4. The analog readings were monitored during RF immunity testing to determine the performance of the various design options.

In this introductory article, we present a top-level block diagram description of the design problem under research. The subsequent articles will be devoted to the RF immunity performance of the PCB assemblies.

hot topics in ESD
Low Voltage Charged Device Model (CDM) Testing at a Crossroads
By Robert Ashton for EOS/ESD Association, Inc.
Introduction
Charged Device Model (CDM) testing is at a crossroads. For the last decade, the Industry Council on ESD Target Levels has recommended that CDM levels of 250 V, as measured with the field-induced CDM test method JS-002[1], are sufficient for high yield manufacture in facilities with basic ESD control [2]. Until recently, integrated circuit manufacturers have routinely provided products meeting the 250 V level and above. This is changing. High-speed interfaces such as 100 Gb/s and above SerDes can no longer meet both the required speed and deliver 250 V CDM levels. ESD protection circuits for 250 V CDM have too much loading capacitance for such high-speed applications. For this reason, the Industry Council has modified its CDM recommendations in the latest update of its CDM white paper [3]. Most devices should continue to meet the 250 V CDM target level but acknowledge that ultra-high-speed pins will no longer be able to reach that level. The Council did not, however, recommend a target of 125 V CDM, the next lowest classification level in JS-002. The Council advised that CDM levels be as close to 250 V levels as practical while meeting performance goals. Dropping CDM levels all the way to 125 V could have severe implications for device yield in manufacture and assembly. This requires a CDM test method providing reliable measurements in the 125 V to 250 V range with an accuracy, repeatability, and reproducibility on the order of 20 V. This cannot be met by JS-002 below 250 V. [4]
378
Mobile phones can interfere with aircraft systems

Navigation and control instruments can be caused to malfunction. During the approach of an Alitalia aircraft at Turin airport on 31 December, 1995, one of the 160 passengers onboard switched on his mobile phone(picture), thus blocking the plane’s autopilot system. There was also interference with the pilot’s contact with the control tower…

379
TVs susceptible to the frequency and type of RF modulation

The annex to IEC 61000-4-3 explains that it was decided to use amplitude modulation (of the radiated RF test signal) and not pulse (digital) modulation as the differences were small. However, when testing televisions for immunity to GSM mobile services, the use of a 200Hz modulation was disastrous, and was only solved by using the correct 186Hz signal…

380
Hunting Radio Howlers – Government Vans on the Track (historical)

The wireless oscillators do not have it all their own way. Re-radiated howls which spoil reception for other listeners are to be tracked down by Government experts employing the latest methods. By the end of this month, the first of the new direction-finding motor-vans will, it is expected, be delivered to the Post Office engineers who are specially…

381
Airport transmissions interfere with some cars on nearby motorway (1)

While towing a caravan south between junctions 24 and 23 of the M1 recently, the turbo of my 29,000 mile Audi A4 TDI suddenly shut down. There were no warning lights or mechanical noises, simply a serious loss of power. I struggled off the motorway and a mobile technician from Audi Assist checked the car the following day. He ran a series of…

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