Since its adoption in March, many of medical device manufacturers, industry consultants, and other interested parties have inquired about how to incorporate the medical electrical equipment standard into their business, AAMI said.

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The standard is based on ANSI/AAMI/ISO 14971, but is not yet at the mandatory implementation phase. To this end, AAMI said most device makers reviewing the new standard appear to be in the information-gathering stage, although some are already developing the appropriate infrastructure to simplify its application.

The revised standard focuses on risk management and the concept of essential performance, which AAMI defined as a measure of a device's effect on user and patient safety.

While some companies expressed concern over the addition of risk management to the standard, the original motivation for incorporating a risk management component, according to Mike Schmidt, co-chair of the AAMI Electrical Safety Committee, was "to provide a structured method for manufacturers to demonstrate equivalent safety of alternate means of compliance - as permitted by the previous edition of the standard."

The AAMI/American National Standard edition is identical to IEC 60601-1:2005 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance from the International Electrotechnical Commission (IEC), with the exception that a few requirements were modified to comply with the U.S. National Electrical Code (NEC) and relevant standards of the National Fire Protection Association (NFPA). Where deviations do occur, the IEC text is included for users' reference.

Source: Association for the Advancement of Medical Instrumentation (AAMI).