Standards and Compliance

Mexico’s regulatory compliance process for electrical safety requires constant attention because of the number of safety standards potentially applicable, exemptions based on use, limited validity periods, provision of samples for local testing, comprehensive labeling and warranty requirements, and the need to coordinate the efforts of test labs, Certification Bodies, customs house brokers, and the importer/certificate holder. By better understanding the key players and documents that make up the regulatory system, manufacturers can more easily and successfully navigate compliance.

Foreign manufacturers sometimes intentionally or unintentionally cut corners on safety and quality because they are less likely to be held liable in the U.S. for problems created by their products. U.S. manufacturers who buy from foreign companies must alter their relationships with such manufacturers to account for this possibility and enhance the safety of their products to protect themselves better if problems do occur.

This article discusses the ongoing revision of IEEE Standard 1720, which provides recommended practices for near-field antenna measurements. It outlines the update process, key changes in various clauses, and new additions to the standard, including improved guidance on anechoic chamber design and non-regular scanning techniques. The revised standard is expected to be published in early 2025.

Mexico’s regulatory compliance process can be challenging due to continuous changes in NOM and other requirements. By better understanding the key players and documents that make up the regulatory system, manufacturers can more easily and successfully navigate compliance for radio and telecommunications devices in Mexico.

Each new version of Wi-Fi standards offers more capabilities but also more complicated regulatory testing requirements. Deciding which capabilities to include and planning for pre-compliance testing can save multiple trips to the test labs and reduce time to market.

This article explores the evolving landscape in the medical industry, focusing on key standards such as IEC 60601-1 and new guidelines implemented to address the next generation of medical devices.

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.

Manufacturers, retailers, and regulators have been working to improve product safety and make recalls more effective. This has been especially important for online retailers who have additional ways to directly contact their customers.

The Commission of the European Union (EU) has proposed providing manufacturers of certain medical...

The U.S. Food and Drug Administration (FDA) has recently authorized the use of vaporized hydrogen peroxide (H2O2) as an established sterilization method for medical devices.