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IEC 60601-1-2 Ed.41 En:2020: Medical Electrical Equipment Standard Overview

IEC 60601-1-2 Ed. 4.1 En:2020 is a pivotal standard in the medical device industry, ensuring electromagnetic compatibility (EMC) of devices. This latest iteration, 4.1, introduces substantial improvements to enhance device safety and performance, while amendments in 2020 further refine testing protocols and criteria.

Main Changes and Amendments:

  1. Immunity Test Levels: Tailored according to various usage environments, now aligned with IEC 60601-1-11 standards.

  2. Safety Enhancement with RF Communications Equipment: Specific tests and levels to bolster safety in proximity to portable RF communications devices.

  3. Port-specific Immunity Tests: Customized immunity tests based on the ports of medical electrical equipment.

  4. Foreseeable Maximum Disturbance Levels: Adjusted immunity tests based on anticipated disturbance levels in different environments.

  5. Harmonization with Risk Concepts: Removal of the "life-supporting" term to better align with safety concepts.

Additionally, the amendments introduced in 2020 brought significant changes to the standard:

  • Testing now includes both minimum and maximum input voltage levels for conducted emissions, voltage dips, and short interruptions.

  • A requirement for power frequency magnetic field matching equipment frequency has been introduced.

  • Shorter Conducted Immunity I/O cables are mandated.

  • A new test for Enclosure Port Immunity to Proximity Magnetic Fields has been added, utilizing IEC 61000-4-39 test and measurement techniques, including Magnetic field testing in 3 spot frequencies (30KHz, 134.2KHz, and 13.56MHz).

Given a three-year transition period from version 4.0, organizations must be currently compliant with IEC 60601-1-2 4.1.

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