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

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Regulatory Affairs

European Union - Medical Devices Regulations

European Union - Medical Devices Regulations Guidelines

European Union - Medical Devices Regulations; Harmonised Standards in the Official Journal

FDA - U.S. Food and Drug Administration

FDA - Center for Devices and Radiological Health

FDA - Medical Device Electromagnetic Compatibility

Medical Devices Agency - UK

FCC - Federal Communications Commision



CENELEC - European Electrotechnical Standardization Committee

IEC - International Electrotechnical Commission

ISO - International Standards Organization

NIST - National Institute of Standards and Technology


Standards Institutes & Test Laboratories

AFNOR - French Standards Institute

Standards Australia

BSI - British Standards Institute

CSA - Canadian Standards Association

NEMKO - Nowegian Test Laboratory

SABS - South African Bureau of Standards

SEV - Swiss Standards Institute


TUV Rheinland

TUV Rheinland of North America

Underwriters Laboratories



World Voltages and Plug Types




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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.