60601-1-11 (home healthcare equipment) maintaining basic safety

The 60601-1-11 standard puts some stricter requirements on medical electrical equipment used in the home than 60601-1. There are three requirements in particular: mechanical strength, environmental conditions and ingress of water or particulate matter, that share a requirement to verify that "basic safety and essential performance" is maintained after the associated stress test is applied.

The problem I have is in the definition of "basic safety". Bearing in mind that verifying the basic safety has to be repeated after each of these categories of testing (multiple times in the case of environmental conditions) it is important to minimise the amount of testing required and its considerable cost.
One testing company that I contacted wants to conduct a vast list of tests and assessments (see below).

Is it really the case that all of these have to be repeated over and over?


· Evaluation of the user & service instructions

· Schematic diagrams and insulation diagram

· Wiring routing

· Markings and Warning labels

· Creepage and clearance

· Review of critical components datasheets and certificates

· Protective Earth Continuity

· Power measurements

· Insulation Tests- dielectric strength, we test if the insulation withstands high voltage

· Leakage currents and patient auxiliary currents

· Protection against excessive temperatures- heat runs, we make sure equipment does not get too hot

· Impedance and current-carrying capability

· Mechanical tests (drop test, over the threshold, ball pressure

· mechanical tests on labels, accessible parts

· Review of Risk Management Plan and File, FMEAS according to the requirements of 60601-1 and 14971

 

I'm not clear about your statement regarding tests being run over and over. My experience has been that the tests are run once. It wouldn't make sense to execute basic safety tests after reviews of labels or the review of the risk management file, for example. The tests you do list are standard, from my experience, for product safety testing and, yes, the test requirements for home-use devices are stronger since it's essentially an uncontrolled environment. Your risk file should address the lack of control in the home environment; e.g., jumping into a pool while wearing the device, etc.

 

Thanks for sharing your experience. You say that [basic safety verification] tests are run once. Does that mean that you would perform the IP, environmental, shock, vibration etc testing first and only afterwards run the basic safety specific testing?
I take your point that label review need only be done once, but some of the basic safety stuff is in grey areas. I could imagine that after shock + vibration tests it is possible that creepage/clearance could be altered. After environmental testing maybe leakage currents may be affected. I cannot find any guidance in the standards for making these judgements.

 

That's a great info. I am a medical device sales professional in USA. Then I really got some useful stuff out of this post. Thanks for this.