Interesting article sent out by Digikey just now:
4th Edition Medical Equipment Standards Impact Power Supply Selection and More
By Jeff Schnabel VP of Marketing, CUI Inc.
The IEC 60601-1 technical standards for medical electrical equipment are about to change, as new usage modes and expectations place more stringent demands on safety and effectiveness. The first territories to adopt the latest version of the standard – known as the 4th Edition – are North America and the EU. Products entering these markets must be compliant by January 2019, and other territories are expected to follow their lead.
For producers of medical equipment, the best response to this move is to understand the new standards straight away, and design new products accordingly. The 4th Edition introduces several changes, including stricter limits on electromagnetic compatibility (EMC), made necessary by generally increasing use of wireless equipment such as smartphones and wearables, and new contexts for the use of medical equipment – such as in the home. Overall, the amendments affect the product design process and documentation, as well as features and performance.