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Developing the Dynamic Hazard-Based Safety Engineering by Introducing the Control-Oriented Model

This article will illustrate why it is necessary to introduce the control-oriented model to hazard-based safety engineering (HBSE), based on a typical large core switching fan-tray architecture design and related failure model. The authors also provide detailed design and evaluation guidelines, which can ensure the control of random hardware failure and avoid systematic failure (both hardware and software), then achieve the safety target (i.e., safety integrity level).

ANSI Z535.7 – Product Safety Information in Electronic Media in Focus

This article introduces ANSI Z535.7, a new standard released in late 2024 addressing product safety information in electronic media. It complements existing ANSI standards by providing guidelines for digital formats, helping manufacturers create consistent safety messaging across both physical and electronic platforms.

FDA Classifies Radiofrequency Toothbrush as Medical Device

The FDA has classified a radiofrequency-based electric toothbrush as a medical device, establishing regulations to ensure the safety and effectiveness of this emerging dental technology.

Implementing “Wordless” Safety Labels

This column discusses "wordless" safety labels, which use symbols and hazard severity panels without text. It explores their benefits, limitations, and implementation considerations, emphasizing the importance of balancing complete information with clear communication in product safety warnings.

Functional Safety: Overview and Methods

Functional safety encompasses various standards and requirements for ensuring safe product operation. Functional safety evaluations are necessary whenever controls are employed to ensure safe product operation, with the process generally similar across projects despite differing nuances in standards and applications.
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Thermal Runaway Energy Release as a Function of the State of Charge

Designing safe products powered by lithium-ion batteries requires an understanding of how the battery pack will behave while undergoing thermal runaway. In this work, fractional thermal runaway calorimetry is used to estimate the energy release from cells at different states of charge when undergoing a thermal runaway.

FDA Releases Reports on Medical Device Safety Initiatives

The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) has released its latest reports on the agency’s activities in support of the safety and innovation of medical devices.

Creating an Effective and Defensible Product Recall

Recalls can create huge problems for manufacturers and product sellers. They can generate new product liability lawsuits that are harder to defend, involve a significant financial cost to implement, and create reputational problems with consumers and retailers. Manufacturers must carefully design a recall or other corrective action that is as effective as possible and adequate under the circumstances. Various government entities are issuing new requirements that can help with these efforts.

ANSI Z535.4 – Safety Labels in Focus

ANSI Z535.4 is a standard developed by ANSI that relates specifically to product safety signs and labels.

The Duty to Warn

Even though warnings and instructions are not followed by all product users, they are important for product safety and product liability defensibility. Manufacturers must decide how safe to design their products and when they can also rely on warnings and instructions to make the product safe.
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