In the titles of these standards, except for the “6’s” it’s a bunch of “1’s” and “0’s”! Well like software code, the arrangement of the 1’s and 0’s and those pesky 6’s do make a difference. We will be using the numbers 60601-1 and 61010-1 a lot in this blog so hopefully they don’t get interpreted interchangeably – part of the point here!
60601-1 is the medical electrical equipment – Part 1 General Requirements for basic safety & essential performance while 61010-1 is the safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1 General Requirements.
Medical device (MD) vs. in vitro diagnostics (IVD) and hence 60601 vs. 61010 is at times very obvious but at other times not so much but Qserve can help in this area. In my career I've developed active devices for MD/IVD and now help others achieve global market compliance with their active MD and IVD equipment, throughout, there are times when one needs to decide which safety standard to comply with. I’ve encountered this while developing a cell therapy product that was used to isolate T-cells from whole blood. Was this a medical device or an in vitro diagnostic (or perhaps just general lab equipment)? What about some of these wearables that obtain samples and send them to a laboratory for analysis – are they a medical device or an in vitro diagnostic? As it turns out the answer to this question is it depends (another example of gray). Often the environment of use and interaction or proximity to the patient helps decide the answer.
A manual on borderline medical device vs in vitro diagnostic with examples is available (Borderline Manual). This is at the top-level of guidance as to whether something is a MD or IVD which may then drive the safety standard choice but may or may not coincide with criteria the 60601-1 standard uses. Per the regulations, if you have an active MD, then chances are 60601-1 is the safety standard. It is important to understand that 60601-1 defines a medical device and hence its applicability to the standard, so it is good to keep this in mind.
The 60601-1 MD definition is: If the equipment has an applied part or transfers energy to or from the patient or detects such energy transfer to or from the patient and which is compensation or alleviation of disease, injury, or disability it is a medical device and 60601-1 applies.
If your product is not a MD, is it an in vitro diagnostic or general laboratory equipment? 61010-1 applies to both IVD and general laboratory equipment but there are some differences in how it is applied in places and especially with respect to collateral support (horizontal) standards and particular support (vertical) standards. Here regulations often inform the full suite (collaterals & particulars) of safety standards necessary (figure 1). For the purpose of this blog, our interest will be IVD.