Under the medical safety standard IEC 60601-1-2:2014 manufacturers must create EMC test plans - but EMC test labs should be careful not help them on matters of Essential Performance
28 May 2019
Under the medical safety standard IEC 60601-1-2:2014 manufacturers must create EMC test plans – but EMC test labs should be careful not help them on matters of Essential Performance
It is a requirement of 60601-1-2:2014 (in subclause 6.2, copied below in BOLD font) that a medical device manufacturer does all his risk management homework and creates an EMC test plan, so that the test lab knows exactly what to do.
6.2 Test plan
Prior to the start of formal testing, a detailed test plan shall be provided to the test laboratory. Deviations from the test plan shall be documented in the test report. See Annex G for guidance on the recommended content of a test plan.
Smaller manufacturers often need help in their EMC test plans for 60601-1-2:2014, but helping a manufacturer deal with anything to do with Essential Performance is really a job for a safety risk management expert. An EMC test lab will almost certainly not have the required expertise.
‘Essential Performance’ is defined in IEC 60601-1 Ed.3.1 as: “Performance necessary to achieve freedom from unacceptable risk”.
There is a significant legal danger for the EMC lab: if some patients or medical practitioners are injured/killed by a medical device that malfunctions due to EMI, the EMC test lab that helped the manufacturer devise their EMC test plan could be held jointly liable, and they would not be able to put up an effective defence because they would have to admit that they did not have expertise in safety risk management, only in EMC testing!
I think it is perfectly OK for the EMC test lab to get involved with how the measurements are done (e.g. how to measure flow rates of millilitres per hour, or rotational speed, with sufficient accuracy and low-enough measurement uncertainty during immunity testing in a chamber where people cannot be present).
But an EMC test lab would be taking on huge uncontrolled financial risks if they helped a manufacturer decide what functions of their products should be tested, what functional tolerances should be permitted, what should be the product’s safety reaction in the case of a fault, how long such safety reactions should take to occur, etc., because these are all issues associated with Essential Performance, and the EMC test lab would most likely not be able to prove they had established competency in such matters.
I have spent a lot of time helping manufacturers understand how to plan EMC tests, but that was in the EMC world, where Product Liability issues are restricted to loss of the service provided by the product, replacement of faulty products, etc.
With 60601-1-2:2014 we are talking about human safety issues and the stakes are very much higher! If the EMC test lab was not very careful to limit the advice they give manufacturers to EMC testing issues alone, a few grand's income from testing could land them in the middle of a Product Liability lawsuit costing many millions.
A Product Liability Trial Lawyer I have worked with said in 2010 that it cost US$250,000 just to set foot in a courthouse on the first day of a trial, and I expect we should probably double that for 2019. And these trials can go on for years, with appeals and counter-appeals and all the rest. For example, I have been peripherally involved in 2010 with one that had been running for 25 years (i.e. since 1985), with no end in sight! Just imagine the legal bills.
To summarise – when a medical device manufacturer approaches an EMC test lab for testing to 60601-1-2:2014, and they don't already have an acceptable EMC Test Plan according to its subclause 6.2 and Annex G, the EMC test lab should think very carefully before providing any assistance in creating that Test Plan!
If the manufacturer hasn't done his safety risk management homework, I would strongly suggest that the EMC test lab advises the manufacturer to sort out everything to do with Essential Performance with a safety risk management expert, before resubmitting their EMC Test Plan.
Of course, many of the larger Approvals Bodies will have in-house medical safety risk management experts, so their EMC test labs can recommend their own in-house resources without stepping outside their own area of established competency.
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