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Does your company develop electrical medical devices?
The standard IEC 60601 is different from other regulatory compliance processes, so it can be challenging for medical device developers who play in this space.
You’ll find that you need to take different requirements into account, depending on the intended end-use of your device. Let's dive into some key insights about the 60601 approval process and our recommended tips for success when implementing these processes:
60601 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 standard is a heavy document, covering about 4500 pages.
One thing that tends to drive medical device developers crazy about it is that it jumps around - you won’t find all of the requirements in one spot because it refers you to different areas, and other standards. The series of standards includes things like usability, EMC, home use and usage in other places.
The environment where your device will be used is a big variable. One consideration could be that your device is intended to be used by patients in their home environment. Another consideration might be if your device is used in the ambulatory environment out in the field. There is a new standard specific to this environment which is more stringent than that for the home environment.
This is part of the reason why 60601 is such a large standard and seen as being so complicated by medical device developers - it has to account for the many different environments in which a medical device may be intended for use.
The testing process for 60601 can be long and difficult. How can you prepare yourself for success when it comes to formal testing and regulatory submissions? Here are a few recommended steps you should take:
A critical consideration is the various types of test labs that exist. Without a firm understanding of the options out there, you could be looking at further expenses and time needed for retesting. It’s important to understand the differences between the different types of labs so that you can choose wisely.
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 basic standard, so not being prepared can add a lot of extra time to your project timeline.
Consider "pre-testing" your device at the test lab using a prototype, especially for EMC testing. This will give you more time to make changes to your product to ensure the safety of your device before submitting it for certification testing.
Even the most experienced engineers have to make adjustments after testing their device for the first time. Many test labs offer pre-testing at a lower cost since less documentation is required. This can save you from very expensive design changes and timeline changes late in the project.
An important part to understand early on is the essential clinical function and essential performance of your device. Where does the product fall in the range of those clinical functions? What are the essential performance characteristics of your device? You need to know this as it impacts your risk assessment and test plan.
Comprehensive, structured documentation including design controls, design reviews, and risk management file will need to be included in the documentation that you send to the certification lab. Your risk management file can take one person over a month of time to put together, and this is after completing 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!
If you find yourself agonizing over 60601, it's important to remind yourself that this standard has evolved over time with the purpose of ensuring that your product is safe for the patients and operators who use it. This is something that we can all agree is essential for medical devices.
As products evolve, safety will have to evolve as well. 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 cyber security. At the moment there is very serious discussion about how hacking can affect patient safety.
As a matter of fact, the home use market has been exploding with devices containing software. Proper risk management is an absolute key to nailing down the safety of your device from the very beginning and the FDA will want to see meticulous records of your risk documentation.
IEC 60601 is a complex standard that trips up many medical device developers. For my part, I’d encourage manufacturers to work with trusted partners who are familiar and have experience with the 60601 standard, and to do so early on. It could save you a lot of additional time and money just by ensuring you’re on the right path early.
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Wade Schroeder is a Medical Device Guru at Greenlight Guru with a noticeable enjoyment of medical device product development processes. As an electrical engineer by trade, he began his career developing medical exam procedure chairs and later designing IVD devices. He has been a risk management enthusiast since the...