IEC 60601-1-2 Testing

Below is a summary of the most important changes to this standard. As with other standard changes, failure to complete these new requirements on time can result in costly delays in placing your device on the market.

While version 60601 of IEC 1-2-3 is still in use, it is often difficult to determine which version of IEC 60601-1-2 should be used. EUROLAB can assist with your FDA medical test and medical device testing and certification.

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

• Determination of immunity test levels according to the intended use environments, categorized according to IEC 60601-1-11: professional healthcare facility environment, home healthcare environment and private settings
• Determination of tests and test levels to increase the safety of medical electrical equipment and medical electrical systems when using portable RF communications equipment closer to the recommended levels of immunity testing specified in the third edition to medical electrical equipment
• Determination of immunity tests and immunity test levels according to the ports of medical electrical devices or medical electrical system
• Determination of immune test levels depending on the reasonably foreseeable maximum electromagnetic distortion level in the intended use environments
• Better compliance with key safety and key performance risk concepts, including deleting the term "life supporting".

This new version also includes the following guidelines in the following areas:

• Determination of immune test levels for special environments
• For the adjustment of immune test levels considering special mitigation measures or intended use
• Risk management for basic safety and basic performance related to electromagnetic disturbances
• Defining immune pass / fail criteria.

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

However, while the U.S. FDA is submitting new applications, it now chooses products that will be considered for the 4th edition. This is especially true for medical devices used in the home care environment.

The FDA does not require compliance with 4th edition for older devices unless the product is modified.

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