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

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LINKS

 

Regulatory Affairs

European Union - Medical Devices Directive

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

 

Standards

CBScheme

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 SUD

TUV SUD - UK

TUV Rheinland

TUV Rheinland of North America

Underwriters Laboratories

 

Consultants

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

 

Other

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

 

Disclaimer

  Powerful Connections  2001-2017. 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 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.