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

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Isolation transformer

An isolation transformer is frequently used as a means of complying with several of the electrical requirements of IEC 60601-1. It has the following advantages:

A 1:1 isolation transformer allows the use of equipment which otherwise would not comply with IEC 60601-1, e.g. PC's.

In systems with separately powered components, e.g. PC, screen, printer, it permits a much simpler and cost effective solution, rather than each component having an IEC 60601-1 compliant power supply.

It isolates the neutral line from earth, simplifying product design in many situations.

It can be simply set up to handle switching between 110V and 230V power systems.

The main disadvantage of an isolation transformer is its size and weight.

Check the information on components approvals for details of what paperwork you will need from the manufacturer of the isolation transformer when you submit your product to a laboratory for testing to IEC 60601-1.

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

Earthing

Mechanical Requirements

Markings

 

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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.