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

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601Help is a free resource for developers of electrical medical devices.

601Help provides a focal point for access to information about compliance with IEC 60601-1, the international product safety standard for electrical medical equipment, as well as the standard's national variants.

601Help gives explanations and interpretations of IEC 60601-1's requirements, links to other sites, and articles on related subjects.

601help offers information on how to get regulatory approvals for medical equipment in various countries, as well as tips on how to prepare your medical device for laboratory testing.

We are continually adding and updating information on the site and we recommend that you bookmark this page and frequently return here for the latest news on IEC 60601-1 related matters.

Do you have specific questions on medical device product safety? Try our 'Ask the Expert' service.

We issue a periodic newsletter to registered users. The newsletter includes new material added to the site, as well as news items of interest to medical device designers. Please subscribe to our newsletter and keep updated.


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

Electrical Requirements


Mechanical Requirements


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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 . 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.