Does your company develop electronic medical devices?
IEC 60601 is different from other regulatory compliance processes and can be challenging for medical device developers in this category. You’ll find that you need to take different requirements into account, depending on the intended end-use of your device.
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I recently had a chat with Leo Eisner, founder and principal consultant of Eisner Safety Consultants and a guy who knows 60601 inside and out. For two decades he has been working as a consultant and for over a decade heavily involved in the standards committees.
Here are some of the insights gleaned from the 60601 approval process:
What makes 60601 different?
The IEC 60601 standards series is one part of putting together a technical file or a 510(k) submission. It’s about more than electrical safety — it covers mechanical safety, labeling and risk management too. The IEC 60601-1 standard is a heavy document, covering about 450 pages.
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One thing that tends to drive medical device developers crazy about this series of standard is that it jumps around — you won’t find all of the requirements in one spot because it refers you to different areas. The series of standards include things like usability, EMC, particular standards such as infusion pumps and surgical robots (draft), home use and usage in other places.
Creating for the ER, home use or other facilities
The environment of the home is a big variable. Another consideration might be the ambulatory environment out in the field. There is a standard specific to the emergency medical services environment which is more stringent than that for the home environment.
This is part of the reason why 60601 is such a large series of standards and seen as being so complicated by device developers – it has to account for the many different environments in which a medical device may be intended for use.
Preparing a timeline for the 60601 process
How can you prepare yourself for success when it comes to formal testing and regulatory submissions? Leo and I touched on just a few of the steps to put in place:
- Put a project plan together. Who will be doing what? What resources will you use? What are your various testing times? All of this should be in your plan so you are able to give yourself some buffer time. Leo has never come through a project without a lab coming back with questions; he recommends at least a 2 to 4-week buffer.
- Know upfront which standards apply. If you go to a test lab without knowing this, they’ll probably tell you that you need to be prepared for testing of other standards that you aren’t prepared for, which will hold up your project. Look at the scope and definition within the scope, as this will tell you what applies to your product.
- Classify your product to the 60601 standard. (e.g. Applied Parts – Types B, BF, CF; IPXX rating per IEC 60529).
- Put an isolation diagram together early in the project. If you don’t match the diagram, you’ll have to redesign the product or the diagram. Usually, you can’t redo power supplies as they’re fixed. An important part is where your power supply is in relation to the patient.
- Determine your requirements for a test lab. For example, local lab vs. quick turnaround required where you don’t care where the lab is. (Leo helps clients to understand the strengths and weaknesses of various labs).
Differences between safety labs
Leo had several clients go to the wrong test labs, which is a critical consideration, prior to his engagement with them. This led to further expense and time needed for redesign, retesting, and redoing the technical file and DHF. It’s important to understand the differences between types of labs and choose wisely.
- Nationally Recognized Test Labs or NRTL are specifically for the U.S. and administered by OSHA. These have been approved through auditing to say they have the right equipment and knowledge to test under certain standards. They’re allowed to tests to 60601, issue a NRTL test mark to 2nd edition (UL 60601-1), edition 3.1 (AAMI ES 60601-1) but not third edition.
- CB Scheme Test Labs are accredited by IECEE (CB Scheme). It is a good idea to use labs that are both NRTL & CB Scheme accredited for IEC 60601-1. Leo doesn’t typically recommend to clients to pay for the additional expense of CB scheme reports & certificate. Typically, with this combination of safety test lab you will get a good test report but still may not satisfy the regulators. You may want to visit the FDA’s Accreditation Scheme for Conformity Assessment (ASCA) workshop webpage (Leo was one of the presenters for the 60601 Plenary on May 22, 2018) to get a perspective of what the regulators are looking for in these test reports.
- EMC Testing. Leo recommends to conduct EMC testing (60601-1-2) prior to safety testing as EMC issues tend to impact safety more than vice versa. The OSHA NRTL system doesn’t include EMC test labs. Some EMC labs know medical very well, but a lot don’t. Know this going in and ask the right questions to make sure you’ve chosen an appropriate test lab.
Tips for early product development
People often tend to think about IEC 60601 too late. Think about planning as early as alpha and beta design phases, not shortly before production. Unless you know the standard well, most people will run into issues with 60601. Testing can easily take 6-12 weeks for the 60601-1 standard, so not being prepared can add a lot of extra time to your project timeline.
An important part to understand is the essential performance (may include multiple clinical functions). Does the product fall out of range of those clinical functions? You need to know this as it impacts your test plan.
Your risk management file can take one person about a month of time to put together, and this is after your ISO 14971 risk management process. Compliance is determined by reviewing your risk management file against the particular issue (e.g. labeling, electric shock). This should be well defined before you do your test plan.
Risk management is of heavy emphasis across the standards and you’ll need to be familiar with all that apply. Do this early!
Why 60601 is vital to keep in mind
There is a very important point to keep in mind when you’re agonizing over the various standards you need to be compliant with – all of them have evolved over time with the purpose of ensuring that your product is safe.
For example, software has become a big deal and with the stories coming out talking about hackers, it’s important to meet standards for networking and cybersecurity. At the moment there is a very serious discussion about how hacking can affect patient safety. Home use products can potentially be impacted, a sinister thought for companies.
As a matter of fact, the home use market has been exploding, which is why Leo focuses on it as an area with clients. Risk management is an absolute key to nailing down from the very beginning and is something FDA will want to see meticulous records of.
An amendment to the third edition of 60601 has started in earnest and will come out in the next couple of years. Look out for this as there will be an impact for all manufacturers. The fourth edition should come out sometime after 2024 and will be a redesign. There is talk that it may be a database standard, which could be a huge expense.
