IEC 60601-1-2 Testing

IEC 60601-1-2 4th Edition Standard

IEC 60601-1-2 – 4th edition – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

NOTICE – IEC 60601-1-2 4th EDITION HAS MANY TECHNICAL AND DOCUMENTATION CHANGES..

Below is an overview of the most significant changes. As with any other standard change, failure to complete these new requirements in a timely manner could cause costly delays in getting your device to market. With the 3rd edition of IEC 60601-1-2 still in use, it is often hard to determine which version of IEC 60601-1-2 should be used. F2 Labs can help with your FDA medical testing and medical device testing and certification. Please give us a call.

The most significant changes from IEC 60601-1-2 3rd edition to IEC 60601-1-2 4th edition are as follows:

Specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments

Specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition

Specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system

Specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition

Better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term “life-supporting”.

This new edition also includes the following guidance in the following areas:

  • Determination of immunity test levels for special environments
  • For adjustment of immunity test levels when special considerations of mitigations or intended use are applicable
  • Risk management for basic safety and essential performance with regard to electromagnetic disturbances
  • Identification of immunity pass/fail criteria.

Your medical device must comply with the 4th edition of IEC 60601-1-2 by December 31, 2018, for Europe, United States (FDA) and Canada.

However, the United States FDA prefers products to be evaluated to the 4th edition now, when submitting new applications. This is especially true for medical devices that are used in a home healthcare environment.

The FDA does not require compliance to the 4th edition for legacy devices, unless changes have been made to the product.

In the European Union (that accepts the CE Mark), medical devices must comply with the 4th edition of EN 60601-1-2. There is no allowance for legacy devices, as is allowed by the FDA.

Legacy Device Definition: A legacy device refers to a computing device or equipment that is outdated, obsolete or no longer in production. This includes all devices that are unsupported or no longer commonly used by most devices and software applications.

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