Do you haveTechnical Questions on Medical Device Product Safety?

Click to try our 'Ask the Expert' service.

If you find 601help a useful resource, click here to see how you can support 601help.

The Information Store for Technical Professionals
  - 500,000 Titles
  - 10,000 Publishers

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

Home   Glossary   Regulatory Affairs   Links   Bookshop   Contact Us

Consulting Services - Click here to check out 601help's Regulatory Consulting Services



Regulatory Affairs

European Union - Medical Devices Directive

European Union - Medical Devices Regulations

European Union - Medical Devices Directive Guidelines

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

FCC - Federal Communications Commision

FDA - U.S. Food and Drug Administration

FDA - Center for Devices and Radiological Health

FDA - Medical Device Electromagnetic Compatibility

Medical Devices Agency - UK




CEN - European Standardization Committee

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



Eisner Safety Consultants  (ESC) is a network of experienced professionals assembled to provide support to the medical device, in-vitro diagnostic, and other high tech electronic device companies

Medical Equipment Compliance Associates LLC



Medical Design Technology (Journal)

Medical Equipment Dictionary

Safety Link - the web's most comprehensive collection of electrical product safety and standards resources

World Voltages and Plug Types



  Powerful Connections  2001-2018. All rights reserved

601help is a Trade Name of Powerful Connections Ltd.

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.