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The Medical Device Developer's Guide to IEC 60601-1

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EMC for MEDICAL DEVICES

Unlike for other types of equipment, EMC is considered a safety issue for medical equipment. Clause 36 of IEC 60601-1 covers EMC, and simply refers to IEC 60601-1-2.

IEC 60601-1-2 is a 'pointer' standard, referring to CISPR 11 for emissions, and various IEC 61000-4-X standards for immunity. These standards are basically test methods for various categories of immunity. IEC 60601-1-2 supplies the test levels and defines the pass/fail criteria.

Differing or additional EMC requirements for specific types of medical devices are found in Clause 36 of the appropriate IEC 60601-2-X standards for particular types of medical equipment. See the IEC 60601 family of standards.

 

European Union

The EU's EMC requirements are covered by the EN versions of the standards given above.

United States

In the United States, the FDA regulates medical devices. The following link gives information on the FDA's approach to EMC:

http://www.fda.gov/cdrh/emc/

Although IEC 60601-1-2 is a 'concensus standard', FDA investigators sometimes have differing or additional requirements. The FDA writes the following concerning IEC 60601-1-2::

"This standard should serve as a baseline for all of the appropriate device areas. However, where there are existing CDRH guidance documents with additional EMC specifications then these will supersede the basic IEC requirements."

Also note that, in the US, medical equipment which intentionally uses EM radiation (e.g. microwave therapy devices), as well as ultrasound equipment, is required to comply with FCC Part 18, for ISM equipment.

 

The IEC 60601 family of standards

UL 60601-1

Type B, Type BF, or Type CF?

The PC as a medical device

Isolation Transformer

EMC for medical devices

Components and Approvals

Submitting a Product for Testing

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The author thanks the International Electrotechnical Commission (IEC) for permission to use material from the IEC 60601-1 international standard . All extracts are copyright IEC, Geneva, Switzerland. All rights reserved. Further information on the IEC, its publications and its role is available from www.iec.ch. IEC takes no responsibility for and will not assume liability for damages resulting from the reader's misinterpretation of the referenced material referenced due to its placement and context in this publication.  The material is reproduced or rewritten with their permission.