The News Room

A new Technical Information Report (TIR) from the Association for the Advancement of Medical Instrumentation (AAMI) offers clarifications on a standard that regulates the use of medical electrical equipment.

ANSI/AAMI/IEC TIR62296, Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements includes clarifications on clauses and requirements within ANSI/AAMI/IEC 60601-1, Medical electrical equipment—Part 1:  General requirements for basic safety and essential performance.

“The standard 60601-1 is written to apply across the board to all medical electrical equipment. You have a situation where what makes sense in general terms may not necessarily make all that much sense when you look at a specific piece of equipment,” says Mike Schmidt, a medical device safety and standards consultant who is co-chair of AAMI’s Electrical Safety Committee, which published the report in the United States. Originally the report was developed by IEC Subcommittee 62A, Working Group 14.

Experts from test houses, which are testing laboratories that offer certification services to the medical industry, are members of Working Group 14. “Obviously they are far more familiar with standard ways of interpreting how a given requirement needs to be applied,” Schmidt says.

 “The TIR explains how to apply those requirements where there is flexibility within certain clauses and requirements,” Schmidt says. “Where a straight read of the requirement would suggest a more or less stringent interpretation, the technical report gives insight into how you might apply the requirement for a specific device or for a specific application. Essentially the 60601 series allows you to comply with any given requirement as long as you are providing an equivalent level of safety to that you would achieve by straightforward compliance with the requirement, the TIR gives insights on the intended level of safety for some specific requirements”

Some of the recommendations raised within the TIR are device-specific, but in many cases it talks about certain types of configurations of equipment,” Schmidt says. “If the equipment has no connection to the main power source because it is battery powered does the requirement apply and if so how,” he says as an example.

Schmidt says the TIR is a useful tool for both manufacturers and biomeds as well as test houses.

To order copies, call (877) 249-8226 or visit http://marketplace.aami.org.