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New Edition of Basic Standard for Electromedical Equipment

IEC press release

Geneva, Dec 13, 2005

Now available from the IEC, the latest edition of the basic standard covering electrical equipment used in medicine is designed to satisfy for at least 10 years manufacturers’ and users’ needs as they relate to safety and essential performance. It is designed to give manufacturers an approach that is simultaneously efficient and comprehensive while also meeting regulatory authorities’ requirements for thoroughness, testability and safety. For the other requirements not covered in the basic standard, the IEC intends to develop specific product standards.

According to Charles Sidebottom, Director Corporate Standards for Medtronic, Inc. in the USA, and also secretary of IEC Subcommittee 62A (Common aspects of electrical equipment used in medical practice), many of today's devices either incorporate computers as parts of the equipment – known as Programmable Electronic Subsystems (PES) – or integrate IT equipment in a medical electrical system. In addition, manufacturers would like to use components and subassemblies (such as power supplies) developed for the IT industry in their equipment because these are available in quantity at low cost.

Risk management and essential performance One of the biggest changes in the basic standard is the inclusion of a formal risk management system (RMS). A formal RMS that meets ISO 14971 is now required for compliance with IEC 60601-1. Sidebottom says that many may see this as the change with the biggest impact on manufacturers.

Another major change concerns requirements for essential performance. Earlier editions of IEC 60601-1 tacitly recognized that a patient is sometimes at risk if a piece of medical electrical equipment fails to perform properly. “It is fundamentally different than something like a toaster,” Sidebottom says. “If the toaster fails, as long as it does not shock you or set your house on fire, it’s alright. You may not get your morning toast, you may be unhappy, but you are not at risk of harm because the toaster didn't work. A medical device may be different. If it fails to perform in a critical situation, you can definitely be harmed.”

This, Sidebottom points out, is the heart of the issue: performance, the absence of which results in unacceptable risk. This does not mean no risk, and the IEC clearly identifies this in the title and scope of the standard. He adds that the basic standard doesn't have many general "essential performance" requirements because that is largely an issue related to particular equipment. IEC 60601-1 clearly establishes that identifying the essential performance of a particular piece of equipment is a task placed on the writers of Part 2 standards in the IEC 60601-1 family.

IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance will be available soon from ANSI's eStandards Store (