UK Seeks Overhaul of AI, Software as a Medical Device

In the wake of its exit from the European Union, the United Kingdom is working to update regulations applicable to medical devices that use software based on artificial intelligence (AI).

The UK’s Medicines and Healthcare products Regulatory Agency detailed its plans in a recently released Guidance, “Software and AI as a Medical Device Change Programme.” The Guidance maps out 11 different “work packages” that would implement changes across the entire medical device lifecycle, from initial product qualification to post-market surveillance…

DILBERT © 2021 Scott Adams. Used By permission of ANDREWS MCMEEL SYNDICATION. All rights reserved.

Assessing Advanced Driver Assistance Systems (ADAS) in Vehicles

Testing Can Help to Ensure Effectiveness and Safety

By Ralph Buckingham

he National Highway Traffic Safety Administration (NHTSA) estimates that 94% of traffic accidents are caused by driver error and the leading cause of these is recognition mistakes.¹ Advanced driver-assistance systems (ADAS) can help decrease accidents, injuries, and fatalities by reducing these errors using electronic technologies. In fact, ADAS is one of the fastest-growing sectors in the automotive industry, with expectations that the ADAS market will see a compound annual growth rate (CAGR) of 11.6% by 2027.²

ADAS are designed to increase the safety of vehicles by assisting motorists with driving and parking functions. They use automated technology, such as sensors, cameras, software, lighting, and audio components to detect obstacles and errors, then respond accordingly. ADAS technologies can range from passive to active, alerting drivers to problems, implementing safeguards, and/or taking control of the vehicle.

Passive systems simply give an alert but require the driver to act. Examples might be systems that make noises or vibrate when an object, such as another vehicle or pedestrian, is sensed in a blind spot or as the car drifts into another lane without a turn signal activated. With the warning, the driver needs to take corrective action. On the other hand, active ADAS not only sense the danger, but also automatically activate the required corrective action, such as emergency braking when an obstruction is sensed.

Simulation-Based Testing for Early Safety Validation of Robot Systems

By Tom P. Huck, Christoph Ledermann, and Torsten Kröger

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.

ndustrial human-robot collaboration (HRC) promises a more flexible production and more direct support for human workers [1]. In HRC applications, human and robot work in close vicinity or even in direct collaboration. Safety fences, which have traditionally been used to ensure the safety of human workers, are (at least partially) absent. Instead, sensor- and software-based safety measures, such as laser scanners, light curtains, velocity limitation, and collision detection, are used to ensure that the robot system does not pose any hazard to human workers. Safety flaws in the configuration of these safety measures can lead to hazards. Thus, a thorough safety validation is required. Furthermore, ISO 10218‑2, the safety standard for industrial robot systems, specifically states that prior to commissioning, a risk assessment must be conducted to identify and assess potential hazards [2].

Expected Service Life of Medical Electrical Equipment

Clarifying Confusion Around “Life” Definitions

By Steli Loznen

he main purpose of mandatory regulations is to obtain marketing authorization to enter global markets. Consequently, a manufacturer must demonstrate that all safety-related aspects, including compliance with relevant standards for basic safety, essential performance, risk management, usability, etc., have been reviewed, that all applicable requirements have been met, and that a quality system mechanism has been implemented.

With regard to medical devices included within the field of the medical electrical equipment (MEE), it is striking to observe how the clauses describing these specific concepts vary among applicable EU Directives, guidelines, regulations, IEC, ISO standards, and other requirements applicable to design, regulatory compliance, marketing, and health professionals.

Moreover, the concept of “expected service life” (ESL) for MEE comes on top of the already existing standards. Thus, due to an incomplete definition of ESL, there is a long chain of misunderstandings regarding the analysis and assessment required to determine compliance with MEE requirements.

Foreseeability: A Critical Analysis in Minimizing Pre-Sale and Post‑Sale Liability

When Is Misuse Reasonably Foreseeable?

By Kenneth Ross

he law requires manufacturers to anticipate foreseeable uses and risks when designing products and providing warnings and instructions. In addition to foreseeable uses, manufacturers must also predict future conduct by users and consider what conduct constitutes foreseeable misuse.

But how far must a manufacturer go to anticipate unintended but foreseeable misuses of a product? How does a manufacturer make this determination while designing the product? What do courts regard as a foreseeable misuse, and what must a manufacturer do about it? Does an unforeseeable misuse become a foreseeable misuse if, after a product’s sale, it comes to light that some people have actually misused the product?

These questions go to the core of a manufacturer’s quest to provide a reasonably safe product before and after a sale. Unfortunately, the answers are unclear and, in most situations, are provided by a judge and jury after a trial.

PRODUCT Showcase

Evaluation of EMC Emissions and Ground Techniques on 1- and 2-layer PCBs with Power Converters

Part 6: PCB Layout Considerations

By Bogdan Adamczyk, Scott Mee, and Nick Koeller

n this article, we discuss the PCB layout considerations and the design of the reference return paths for the one- and two-layer boards.

1. Introduction

The PCB layout and the design of reference return connections (may also be referred to as grounding) play a critical role in the EMC performance of any circuit. This is especially critical for power converters, which are the focus of this series of articles. In circuit design, it can be easy to focus on power and signal trace connections while overlooking or not focusing enough attention on how circuit current returns. Proper reference return design can especially be challenging in single- and two-layer designs where best practices can’t always be applied. It is important to understand and visualize the path of the return current so its entire loop area can be controlled by design. The complete loop area of each circuit tends to be the dominant factor when compared with other parasitic inductances associated with the components or vias. This inductance has a detrimental effect on the EMC performance.

Understanding Footwear and Flooring in ESD Control

By Dr. Jeremy Smallwood for EOS/ESD Association, Inc.

I have a floor that complies with IEC 61340-5-1 and ANSI/ESD S20.20, and buy footwear that also complies, so that’s sorted then?

Well, not really. It’s a good starting point, but you need to know that the flooring and footwear work together. Unfortunately, I’ve seen cases where they don’t. If that happens, you’re fooling yourself if you think you’ve got human body ESD risk under control. I’ve seen a person wearing footwear that measures about 10 MΩ, standing on a floor that measures about 10 MΩ, but their resistance from body to ground was over 1 GΩ, and a body voltage test while walking showed well over 100 V.

Hang on – how can that be? If the footwear and flooring were both about 10 MΩ, surely the resistance from body to ground should have been about 20 MΩ?

In an ideal world, you might think so – but there’s another factor – contact resistance between the footwear and the floor.

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