ispce

Peter Shearstone, VP of Global Quality and Regulatory Affairs at Thermo Fisher Scientific, will be the Keynote Speaker at the 2024 IEEE International Symposium on Product Compliance Engineering (ISPCE). 

Tin whiskers are small, hair-like structures that can form naturally from the surface of tin components. This article explores 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.

This article identifies the burn injury threshold conditions associated with finite thermal mass objects and presents a model for predicting the degree of burn injury.

This article provides an overview of lifecycle issues for interoperable medical products that are not sufficiently addressed in existing medical device standards and identifies lifecycle concepts from other domains that may be adapted for interoperable medical systems.

This article outlines the instrumentation and calculations performed to evaluate the severity of the exposure risk to unfiltered artificial light.

The use of chemical substances and their potential impacts on human health and the environment is a concern world-wide. This paper looks at substances and substance restrictions, why they are restricted, and how they affect the safe use and disposal of electrical, toy, and medical products.

This article 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.

Direct Current (DC) applications have become more prevalent in recent years, primarily due to the increased usage of renewable energy and energy storage systems. A review of the existing safety standards and other literature shows that there is limited experimental data on DC human body resistance. In particular, no information was found by the authors describing the repeatability of DC body impedance and the effect of contact material and other variables.

ISO 26262 defines the probabilistic metric for random hardware failures (PMHF) as the average probability of a violation of a safety goal associated with a failure over a vehicle’s lifetime and architecture metrics. In this article, we propose a method to calculate the PMHF and expand the application to redundant subsystems that are not adequately described in the standard.

ISO 26262 requires a variety of processes and frameworks for safety management, safety concept development, requirements flow-down, and verification & validation activities.