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Regulatory updates for the medical device industry

It’s getting serious: IEC/EN 60601-1-2 will become mandatory in 2019!

The transition periods for IEC/EN 60601-1-2 will expire at the end of 2018. Companies now need to start their final sprint; this is their last chance to get ready for the new requirements.

New requirements for electrical medical equipment

Long announced, much expected and soon finally in force – the 4th edition of the IEC/EN 60601-1-2 standard for Europe and North America will become binding at the end of 2018. By this date at the latest, all electrical medical equipment must be in compliance with the new requirements for electromagnetic compatibility.

Why the new standard?

The environments in which medical equipment is used are more complex than ever; technologies have advanced dramatically. The new requirements take these changes into account, addressing aspects such as electromagnetic compatibility of medical devices in environments that include high-frequency signals from Wi-Fi or Bluetooth, and cellphone signals.

What are the main changes?

As one of the key changes of the IEC/EN 60601-1-2 standard, the 4th edition will place greater emphasis on the “intended environment of use.” In this context, it mainly describes the requirements for professional healthcare facilities, home use and “special environments.” Professional healthcare facilities include environments such as hospitals, which are facing high EMC challenges on the one hand, but have specially qualified medical professionals to handle equipment on the other. However, with respect to home use the standard addresses the requirements associated with non-professional users. The term “special environments” as used in the standard summarizes locations with high levels of electromagnetic interference, such as rooms used for radiation therapy.

Stricter test specifications in the 4th edition are designed to ensure electromagnetic immunity under these conditions. The new standard no longer uses categorizations referring solely to devices, such as “life-supporting.”

What other significant differences compared to the previous edition does the standard show?

Other differences between the 4th edition of the IEC/EN 60601-1-2 and the previous one, apart from consideration of the “environment of use,” include:

  • Risk analysis for determination of test levels now required
  • EMC now an integral part of risk analysis
  • Increased test levels for immunity requirements (contact and air discharges, etc.)
  • New immunity tests required
  • EMC test plan necessary as a result of risk analysis
  • New requirements for user information in operating instructions

 

Regulation for introduction of risk management system in line with ISO 14971 for basic safety and key performance indicators for electric interference complete the new standard.

Rouven Rosenheimer

Rouven Rosenheimer

Senior Account Manager Active Medical Devices

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