FAQ’s for Mallory’s IEC 60601-1-8 Medical Alarms

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What is IEC 60601-1-8?

IEC 60601-1-8 is a specification that covers the prerequisites for audible & visual alarm use in medical equipment. This specification is a subsection of IEC 60601 which covers all requirements for medical equipment. “IEC” spec.’s are controlled by committees in Europe.

Is IEC 60601-1-8 compliance required in the U.S?

Yes- for new medical equipment in the U.S, and it’s also required for Europe and Canada.

What does IEC 60601-1-8 specifically cover for audible alarms?

There are many detailed and complicated requirements for audible alarms in IEC 60601-1-8:

  • Up to 3 medical priority tones (low, medium, & high) may be used.
  • For each medical priority tone, all required aspects of the sound profile are listed.
  • For each medical tone, there are different melodies available depending on the medical application, and there is a “general” melody which can be used for any medical application.
  • Requirements are listed for any non-medical sound that the equipment uses such as a beep when a button on the medical equipment is pressed.

Do I need to be worried about all the detailed requirements in IEC 60601-1-8?

Only if you are on the medical equipment design team, or if you are a Mallory engineer tasked with making audible alarms which meet all requirements of IEC 60601-1-8.

Are their different versions of IEC 60601-1-8?

Of course. The committees in Europe can’t stand to leave a good spec. alone. The most current revision is IEC 60601-1-8 AM2 (2020) which was issued in 2020 as the name indicates. The previous revision was IEC 60601-1-8 AM1. A new version is scheduled to be released in 2024.

Are medical companies aware of new version IEC 60601-1-8 AM2 (2020)?

There will be people at the medical companies aware of this new version. That being said, if the current medical equipment design team is tasked with meeting previous version IEC 60601-1-8 AM1, they may not be aware of the new AM2 (2020) version, and they may not currently care that there’s a new version.

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