To make testing mandatory under legislation, i.e. meaningful in law, a period between tests would have to be specified, explicitly (as well as the use of a testing standard, e.g. 62353), for devices based on the risk presented by devices, their likelihood of failure and the environment that they're used in.
In any case, given the diversity of devices and the risks presented, if testing were not performed at "regular intervals" that're considered acceptable under law, enforcing "reasonable testing intervals based upon risk" for a particular devices would be difficult. The problem is that individuals' idea of reasonable test interval varies in practice - usually heavily influenced by the resources that're available for testing.
To make the requirements of legislation easier to implement hence enforce, perhaps, there would have to be a mandatory test on all devices at an interval that's fixed and, ultimately for many devices and applications, the interval between testing would not be realistic given the number of devices in a typical general hospital and the complexity of tests associated with a significant proportion of the high-risk devices.
Visual inspection, basic functional checks and electrical safety checks would be necessary whatever the medical application or electrical device involved. The basic testing methods indicated in 62353 are, in fact, almost identical to those indicated in 60601-1 under normal conditions except that IR tests are now specified, explicitly, lower earth bond currents appear to be encouraged, plus there are some other relatively minor changes in allowable earth-bond figures, etc.
The tests now formally specified in 62353 but not 60601-1 consist of stuff that most individuals have considered good practice for years when performing 60601-1 tests, anyway; most of which have already been included in many electrical safety testing products already on the market.
One thing that 62353 is very useful for, even if its use is not mandatory, is that manufacturers and service agents can use it as a benchmark for stating, more explicitly than 60601-1 does, good practice in routine safety testing in much the same way as manufacturing standards are used by manufacturers to illustrate to notified bodies/competent authorities, etc, that good or "state of the art" engineering/design practices, essential safety aspects and performance considerations are being applied.
Therefore they have a good argument when specifying the requirements of servicing/testing, including safety testing which was previously out of their "control" and the domain of EBME/Medical Physics, etc, based upon selection of tests that were not previously specified in writing - hence somewhat open to interpretation.
I must admit that I do have concerns that it is possible that tests indicated in 62353 could "pass" medical devices with a single fault condition present (that have actually been designed under 60601-1 to protect the patient under a single fault condition) and that some leakage limits (especially compared to those in the in the 3rd edition 60601-1) may not be fully compatible with 60601-1.
Potentially, over the life of the device or system, lowering the "safety margin" designed into new products that're manufactured by companies adhering to the essential safety requirements of 60601-1. However, saying this, I've not had an opportunity to fully study the "ins and outs" of both the standards and compare them properly, yet, plus failures are few and far between so the risk of a scenario where 62353 misses an SFC in a medical device and a second fault occurs is probably very low thus an acceptable one.
Perhaps anyone who disagrees would care to comment?
