Does long-term body worn medical monitoring device need to meet IEC 60601-1-11?

[Roland chung]

Hi all,

There is a long-term body worn monitoring device (48 hours at least). Since the patient can go everywhere including home while wearing, the auditor said IEC 60601-1-11 should be considered. Is that true?

Thanks,
Roland

 

[isoalchemist]

Something similar was in a previous discussion. Hope this works and helps

http://elsmar.com/Forums/showthread.php?t=40890

 

[Roland chung]

I am afraid the link you shown is not relevant to this topic.

 

[Peter Selvey]

Yes, the standard indicates that it is applicable if the equipment can be used in the home, even if the device is for example owned by a hospital, set up by the hospital, and only given to the patient for temporary use.

The standard is new and there are some parts which I think are controversial, such as the IP and Class II ratings. There are also some expensive tests for performance under various stress tests like vibration and temperature.

These expensive tests are controversial for two points: 1) why just home use? They should apply to all equipment. 2) in the real world, a degree of engineering judgment is necessary i.e. look at the individual design what tests are important. Some equipment is sensitive to temperature and humidity so careful tests over the full normal environment is reasonable, other types are sensitive to vibration. To keep the costs down, the manufacturer should be able to select the tests as appropriate for the device (I hesitate to say risk management, since it is really an engineering judgement).

 

[Roland chung]

Thank you. You already mentioned my concerns (IP test and mechanical strength test).

When I checked Holter's standard (60601-2-47:2012), such strict requirements cannot be found. I think Holters available on the market are hard to fully meet the 60601-1-11. Are we aware of any incidents happened with 2nd edition approved Holters outside the clinical setting?