IEC 62368-1

This article discusses the IEC 60601 Amendments Project, for Medical Electrical Safety, some of the changes to the General and Collateral Standards of the Project, and their impact on manufacturers. The future of the 60601 series of standards is also discussed.

Product standards, such as IEC 62368‑1 for ITC equipment, struggle to keep up with technology changes, even when they are designed to be adaptable – such as this hazard-based standard. Unexpected consequences can develop with the introduction of disruptive technology that takes advantage of a seeming loophole in a standard and move forward without getting a full evaluation under the standard. Fault managed power systems, such as PoE, push the standard in getting proper evaluation. This paper is a case study including a detailed proposal as to how to address an issue such as this within the standard.

This article discusses the legislation that applies when placing radio equipment on the Saudi market. For product manufacturers intent on exporting radio equipment to Saudi Arabia, the fact that the relevant legislation was adopted at the national level is significant. The article gives an overview of the Saudi legal framework, including obligations falling upon radio equipment manufacturers and importers.

This paper provides an overview on the importance of ethical obligations to help ensure end-product safety and its certifications effectively address and satisfy component level application considerations. These are known as “Conditions of Acceptability” for most North American certification reports and “Application Considerations” for most European Union certification authority reports.

This article discusses additional requirements that designers and safety professionals may want to consider beyond the base standard for their product based on the environment and user exposure.