The International Electrotechnical Commission, Geneva, Switzerland, introduced the fourth edition of IEC 60601-1-2:2014, the standard specifying electromagnetic compatibility (EMC) requirements and tests for medical equipment and systems. TÜV Rheinland, a leading global certification organization, strongly encourages medical device makers to determine how they will transition to the newest revision, which introduces significant technical changes, including new immunity and risk analysis requirements.

The revision mandates compliance of new products by April 2017 in the USA and all products by August 2017 in the European Union. In the USA, existing products will need to comply if changes are made. Moreover, the US FDA already accepts the fourth edition.

The new revision imposes significantly higher EMC test levels; for example, the ESD test levels are increased to 15KV air and 8KV contact, almost double the current specifications. In addition, there is a new wireless proximity test that increases the radiated immunity test levels to 28V/m at some frequencies, a significant change from the existing requirements. Therefore, manufacturers are advised to review the design of their products now to determine if any changes will be required to ensure timely compliance. Advance planning is critical for compliance, especially if a manufacturer has multiple products, all of which will eventually need to be re-tested to the new requirements.

The fourth edition changes the basic EMC compliance philosophy to define tests and limits according to risk and intended use instead of a device type.

Medical Design Briefs Magazine

This article first appeared in the February, 2015 issue of Medical Design Briefs Magazine.

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