Standards and Compliance

Stay informed with standards updates, explore standards insights by topic, understand the importance of product liability, and learn international compliance best practices to ensure your products meet global regulatory requirements effectively.

EU Harmonized EN EMC Standards

No new harmonized EN EMC standard has cleared the OJEU since 2022 — and the backlog is only getting more tangled. Between a landmark court ruling, a copyright fight with ISO/IEC, and the EU's pivot toward Common Specifications, the rules for proving compliance are shifting under manufacturers' feet.

Global Power Cordset Compliance Requirements for Device Manufacturers

A power cord might look like a commodity part, but it's one of the most heavily regulated subsystems in any globally distributed device. Five-country certification rules — covering plugs, cables, connectors, and cord sets — can quietly stall shipments if engineering teams get the documentation wrong.

Global Market Access for Bluetooth Devices

Getting a Bluetooth device to market in one country is a project — getting it to market in 30 is a whole other challenge. Grace Lin maps the regulatory landscape across major economies, from FCC certification to RF exposure rules and labeling requirements worldwide.

Top 10 Barriers Manufacturers Face with Medical Standards

Medical electrical equipment standards are complex—and noncompliance is costly. This article breaks down the top 10 barriers manufacturers face when navigating IEC 60601 and related standards, from EMC testing and isolation diagrams to risk management and software documentation, with practical guidance to streamline certification and avoid delays.

The IEC 60601 Family of Standards and the 4th Edition of IEC 60601‑1

The IEC 60601 family of standards is undergoing its most significant update in decades. This article explains how the 4th Edition of IEC 60601‑1 restructures safety, performance, terminology, and collateral requirements—and what these changes mean for medical electrical equipment development, conformity assessment, and future regulatory pathways.
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A Combat Scenario-Based Model for Quantifying Ethical Decision‑Making in Military AI

Can military AI make ethical decisions in combat? Researchers developed a mathematical model integrating national ethics, international law, and battlefield variables. Testing across 38 scenarios revealed which situations need human oversight—and which don't.

ISO 17025 Accreditation from a Test Lab’s Perspective

Third-party test labs undergo rigorous ISO 17025 accreditation audits lasting days or weeks. Learn what auditors scrutinize—from equipment calibration to facility layouts—and why accredited labs provide manufacturers with the highest-quality compliance testing and reliable results.

Global Efforts to Make a Safer and Better Internet for Children

With the increase in online transactions, use of social media, and digital connectivity, ensuring the safety and well-being of minors has become a high priority for parents, digital service providers, policy makers, and regulators across the globe. The advancement of age-appropriate design and age verification standards by the IEEE Standards Association (IEEE SA) is helping stakeholders, including digital services providers, policy makers, and regulators, to address requirements from various jurisdictions around the world. 

Failure to Follow Warnings and Instructions

Warnings and instructions are a necessary part of any safe product. Rarely is a design so safe that there are no warnings and instructions that need to be followed. On the other hand, failure to follow warnings and instructions can turn an otherwise safe product into one that is hazardous. Is it foreseeable that users will not read or follow this information? And if so, what effect does that have on the manufacturer’s potential legal liability for injuries suffered while using this product?

CISPR 11: A Historical and Evolutionary Review

CISPR 11 is the International Standard for electromagnetic emissions (disturbances) from Industrial, Scientific and Medical (ISM) Equipment. The official title of the standard is “Industrial, Scientific, and Medical Equipment – Radio-Frequency Disturbance Characteristics – Limits and Methods of Measurement.” The premiere edition of the standard was released in 1975 and the latest edition (Edition 5.0) was released in 2009. The standard includes both limits and methods of measurement for conducted phenomena and radiated phenomena. This article traces the history and development of the content of the standard over the last 35 years.

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