What the FDA Moving to IEC 60601-1 3.2 Means for Manufacturers

The FDA has listed IEC 60601-1 3.2 as a recognized standard 

In August 2020, the International Electrotechnical Commission (IEC) published Amendment 2 to 60601-1, and as of May 30, 2022, the FDA has listed 60601-1 3.2 as a recognized standard. By December 17, 2023, the changes set forth in this amendment will replace version 3.1. For medical device manufacturers in production, this update can impact the rollout of a new product. 

Here’s what you need to know about the update, the state of standard recognition internationally, and what this means for devices currently in development. 

What is IEC 60601? 

IEC 60601 encompasses a series of standards for medical electrical systems and equipment that ensure basic safety and essential performance measures are in place. The standard applies to medical electrical equipment where an applied part either transfers energy or detects an energy transfer to or from the patient and provides up to one connection to supply mains – where the main power is supplied from the wall or at a greater level than what is supplied from the wall (110V, 220V, etc.). 

The device being certified should be used in either diagnosis, monitoring, or treatment of a patient, or in alleviation or compensation of an injury, disease, or disability. These standards don’t extend to in vitro diagnostic equipment or implantable devices. 

Before a manufacturer puts their device in the market, it needs to be compliant to 60601 standards. Once a new standard is published, it may take different lengths of time, depending on the country, to “harmonize” the standards – find middle ground between the standards so a U.S. manufacturer can sell in the EU, for example. 

When IEC 60601-1 was published, it was seen as one of the “costliest” standards to be published, with older versions running manufacturers anywhere from $10,000 to $20,000 to get their low-risk products certified. In newer additions, costs have risen higher.

The IEC 60601-1 guidelines represent the general standards for all devices that fall under the category mentioned above, but there are also more specific standards, clauses, and subclauses that need to be met depending on the type and characteristics of the device. For example, if the medical device includes X-ray, it would need to meet horizontal standards for collaterals under 60601-1-3. Hearing instruments would need to follow 60601-2-66. 

What is IEC standard 60601-1 3.2? 

The newest edition, IEC 60601-1 version 3.2, is concerned with potential electrical, thermal, mechanical, and functional hazards that may happen to patients or operators in normal conditions and fault conditions. The amendment was added to fill gaps and ensure that no unacceptable risks for patients or operators occur. You may also see this standard referred to as Amendment 2 to IEC 60601-1, IEC 60601-1 A2:2019, or Version 3.2 of IEC 60601-1. 

Because medical device companies can take anywhere from a year to 3 years to get their product to market, if you’re currently producing a device and plan to apply for clearance after December 17, 2023,  you should ensure that you are meeting 60601-1 3.2 standards. Only 2 amendments are able to be added to standard versions, so the next updates will come when version 4 of the standard is published, which IEC has said won’t happen until after 2024. The current additions address matters that were determined to be too urgent to wait for a new version of the standard to come out. 

In addition to new products on the market, the change in standards will also affect anything being updated or obsolete components. If you’re making updates to your medical device and resubmitting it after December 17, 2023, your device needs to meet the new standard. 

For obsolete components, when you replace it with a new component, that component does need to meet current requirements and get recertified. At that point, you can decide whether it makes sense to make a production change to a new component, or you could end the life of the product and not make it anymore. 

Where has 60601-1 3.2 been approved or recognized?  

While the FDA is transitioning to the new standard on December 17, 2023, here is the status of other organizations and regions: 

  • OSHA / NRTL (U.S.): 2.0, 3.0, 3.1, and 3.2 are all deemed acceptable with no end date yet announced on prior versions 
  • Health Canada: The transition hasn’t been announced yet, but a CSA amendment has been published 
  • EU – NB: This is currently pending 
  • Brazil: 3.2 has been deemed acceptable but no transition has been announced 
  • Singapore: 3.2 has been deemed acceptable but no transition has been announced 
  • India: No transition has been announced, but generally, whatever version is the latest is acceptable 

What are the differences between version 3.1 and 3.2? 

While the first amendment of 60601-1 Version 3 brought about the most changes, Amendment 2 provided substantial updates that were determined to be too urgent to wait for version 4. The items that were considered for inclusion needed a 2/3 majority – 78 out of 109 items presented to National Committees for inclusion ended up in consideration. 

The most major changes were added in:

  • Clause 2 – Normative references 
  • Clause 3 – Terminology and definitions 
  • Clause 7 – Identification and marking 
  • Clause 8 – Protection against electrical hazards 
  • Clause 11 – Protection against excessive temperatures and other hazards 
  • Clause 13 – Hazardous situations and fault conditions 
  • Clause 14 – Programmable electrical medical systems (PEMS) 

Updates were made to definitions, terminology, out-of-date references to other standards, clarifying figures and tables, and several layout and design additions and modifications, including specification for lights and indicators, opto-coupler selection. Also, many references incorporated in the guide come from IEC 60950 or were derived and modified from the standard. 

What do manufacturers need to know as this change comes into effect? 

Manufacturers who currently have medical devices in development need to be mindful about when they will be applying for clearance. For anything currently on the market, you don’t have to meet this new standard unless they have to make a change that requires review by the FDA. For new devices, make sure you are using parts that are compliant to the new standard, including power supplies. 

RAM PSUs meet 3.2 requirements 

If you’re looking for PC-based power supplies for your medical devices in production, you’ll be set for the new standard with RAM Technologies power supplies. Our PSUs meet 3.2 requirements and we are currently undergoing the certification process. Your road to approval should be as smooth as possible, and we want to be an easy step in your journey.

If you have any questions about our PSUs or want to place an order, reach out to us today!

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RAM Technologies’ power supplies are 60601-1 certified and meet 60601-1-2 EMC standards.  Contact us for details.

More Resources:

4 Tips for Choosing a Medical-Grade Power Supply

5 Questions to Ask Before Buying a Medical Power Supply

Why Buy a Medical PSU from RAM Technologies? 

60601-1 and Medical Device Manufacturing Tips

 

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