New Medical Equipment Standards Impact Power Supply Selection and More

In summary, the new medical equipment standards are going to have a big impact on power supply selection.
  • #1
Interesting article sent out by Digikey just now:

4th Edition Medical Equipment Standards Impact Power Supply Selection and More
By Jeff Schnabel VP of Marketing, CUI Inc.


The IEC 60601-1 technical standards for medical electrical equipment are about to change, as new usage modes and expectations place more stringent demands on safety and effectiveness. The first territories to adopt the latest version of the standard – known as the 4th Edition – are North America and the EU. Products entering these markets must be compliant by January 2019, and other territories are expected to follow their lead.

For producers of medical equipment, the best response to this move is to understand the new standards straight away, and design new products accordingly. The 4th Edition introduces several changes, including stricter limits on electromagnetic compatibility (EMC), made necessary by generally increasing use of wireless equipment such as smartphones and wearables, and new contexts for the use of medical equipment – such as in the home. Overall, the amendments affect the product design process and documentation, as well as features and performance.
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Does this mean that older equipment will have to be retired? If so, what will become of it? Just curious.
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Ah yes, things do change and changes have unforeseen consequences. The FCC puts limits on max levels of EMI allowed. But some percentage of the devices in people's pockets must be presumed to be malfunctioning and in violation of the limits. That is one of the arguments used against use of passenger electronics on airplanes; it is the malfunctioning ones that count.

Whereas the 3rd Edition immunity specifications anticipated professional users’ ability to enforce a “quiet” electromagnetic environment in the vicinity of medical equipment, the new 4th Edition classes acknowledge that this is no longer feasible given the sheer ubiquity of wireless equipment, including consumer smartphones, wearables, and other devices, acting in any environment at any given time.
dlgoff said:
Does this mean that older equipment will have to be retired? If so, what will become of it? Just curious.
They discuss that:
The US and EU have harmonized the timeframe for mandatory compliance with the 4thEdition 60601-1 standard. After December 31, 2018, all new products submitted to the US Food & Drug Administration (FDA) must comply with the new standard, and the EU has set the same Date of Withdrawal (DoW) for its current 3.1-based EN 60601-1-2:2007 standard. However, while the US will continue to allow legacy equipment to be marketed in the US, the EU will make no such concession: all medical devices imported after the DoW must be compliant with the 4th Edition.
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anorlunda said:
They discuss that:
Guess I missed that. Thanks.

1. How will the new medical equipment standards impact power supply selection?

The new medical equipment standards will require power supplies to meet certain safety and performance requirements, such as low leakage current and high reliability. This may result in the need for specific power supply configurations or certifications, and may also increase the cost and complexity of power supply selection.

2. Will the new standards affect existing medical equipment?

Yes, the new standards may affect existing medical equipment if it does not meet the new requirements. In this case, the equipment may need to be updated or replaced in order to comply with the standards.

3. What are the potential benefits of the new medical equipment standards?

The new medical equipment standards aim to improve the safety and performance of medical equipment, which can ultimately benefit both patients and healthcare professionals. These standards may also promote innovation and advancements in medical technology.

4. How can manufacturers ensure compliance with the new standards?

Manufacturers can ensure compliance with the new standards by thoroughly understanding the requirements and testing their equipment accordingly. They may also seek certification from regulatory bodies to demonstrate compliance.

5. Will the new standards impact the cost of medical equipment?

The new standards may impact the cost of medical equipment, as manufacturers may need to invest in new technologies or components to meet the requirements. However, the overall cost may be offset by the potential benefits of these standards in terms of safety and performance.

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