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.
Figure 1: 61010 standard defines its scope but are refined by regulations whereas 60601 is more linear.
Whether MD or IVD, once you’ve landed in either 60601-1 or 61010-1 the testing within the standard is fairly straightforward. Both standards discuss normal and single fault conditions however, there are no essential performance implications in 61010-1. Both standards look at safety related to electrical, mechanical, thermal, fluids and radiation as well as labeling and instructions for use. Both standards rely on collateral standards for extending general safety assessment and rely on particular standards for product domain specific safety considerations where appropriate. A nuance I’d like to share about in this blog is how IVD interweaves 61010 with aspects of 60601. This can be seen with the collaterals related to risk, usability and software.
For context let’s start with the scope of each of these standards:
Table 1: Scope comparison between 60601-1 & 61010-1
Assume we have an active health care device but not a medical device per 60601-1 (i.e., no applied parts, no energy transfer etc.). Looking to 61010-1, we can see that it differs in scope from 60601-1 in a couple significant ways: 1) it is concerned with general safety with no mention of essential performance and 2) it applies in a general manner to a broad domain of electrical equipment of which some are laboratory equipment, and some are IVD. We discussed essential performance in the context of 60601-1 prior (see Essential Performance). 60601-1 considers essential performance a significant aspect to patient safety (its scope being patient and user safety). 61010-1 is geared towards a broad range of electrical equipment unrelated to health care in many cases or towards laboratory equipment with no patient contact. 61010-1 hence focuses on user (operator and environmental) safety.
The other potential nuance is that within 61010-1’s scope (Part C of Table 1 above) we need to further drill down and determine whether we are in the IVD or general laboratory equipment category. 61010-1 does not provide criteria as to deciding between IVD and general laboratory equipment and hence relies on the regulations. There is a bit of a circuitous path regarding application of collateral standards for IVD which we will briefly explore. Briefly, particular standards supplement details at the domain level and so get applied (like 60601) based on the product’s “particulars.” One example related to IVD is the particular standard 61010-2-101 (particular requirements for IVD equipment). This particular standard is meant to be used alongside 61010-1 and modifies it in places throughout the standard. Particular standards related to 61010-1 are more straightforward and hence not our concern in this blog.
For a bit more context (collaterals/particulars) you can look at the blog cited above or check out the early part of a (Free Webinar) on how general standards call on other standards to provide additional general considerations (EMC, Software, Usability etc.) and/or additional particular considerations (equipment domain specifics). Both 60601-1 and 61010-1 do this.
Back to our main interests which are key collateral standards (used in submissions). So, let’s look at how 60601-1 and 61010-1 compare with our interest being IVD.
Table 2: Key Collateral Safety Standards 60601 vs 61010 (IVD)
Note 1: The only place software is mentioned in 61010-1 is clause 16.1 where it is mentioned in the context of reasonably foreseeable misuse and assessing hazards that could be software-based.
The electromagnetic compatibility (EMC) collateral is straightforward in that 61010-1 explicitly cites 61326-1. (Too bad it isn’t numbered 61010-1-2 following the same pattern as 60601, keep that in mind as it can be hard to remember 61326-1). As a note, EMC, like collaterals below, can be influenced though by the planned environment for your IVD/lab equipment (i.e., if your IVD device can or needs to live alongside MD equipment it could behoove you to bump up the rigor by adopting 60601-1-2 the MD EMC collateral). EMC though is more straightforward, let’s look at the collaterals circled in red (Table 2 above) next.
At Qserve, we help many MD and IVD organizations and when it comes to risk analysis, software and usability they are treated in a very similar fashion. Why? The safety standard 61010-1 doesn’t drive it. Our IVD landed us in 61010-1 which provides options on risk analysis, only mentions software in one spot and bundles usability into its own risk Annex J. This is different from when we land in 60601-1 as these supporting collaterals are explicitly called out and align with medical device regulations (Table 3 below).
Table 3: Comparison of 60601 vs 61010 key collateral alignment with regulations
- Note 1: The FDA recognizes 62304 as a consensus standard for MD/IVD. The draft guidance soon to replace the 2005 version on content of premarket submissions for device software functions harmonizes terminology and recommendations with 62304 (Content SW Submissions).
- Note 2: 62366-1 is referenced and aligned with the FDA’s guidance on applying Human Factors and Usability Engineering to Medical Devices. (HF & UE) 62366-1 is also referred to in 14971 regarding user risks.
- SOTA = State of the art. It is utilized by notified bodies in assessing compliance. Although 62366-1 & 62304 are not yet harmonized they are recognized as SOTA.
The point of all this is to highlight how medical devices are required to comply with the safety standard 60601-1 that is non-ambiguous and aligns well with both EU and FDA regulations with respect to collateral standards. 61010-1 being a more general standard including non-health related products requires the IVD device developers to utilize the IVD regulations in order to pick the balance of the safety related collaterals. The EU In Vitro Diagnostic Regulation (IVDR) guides IVD collaterals in the EU and the FDA (which treats IVD like MD) guides IVD collaterals in the US.
The IVD safety/EMC suite can be a bit confusing as to how we end up doing a lot of MD collateral work. As a long time MD developer, 60601-1 was straightforward but 61010-1 not so much. It isn’t 61010-1 driving MD level collaterals in this case, it is the IVD regulations. Not so binary I suppose and definitely an area Qserve can help with should the need arise!
