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AN INTRODUCTION TO CERTIFICATION AND REGULATORY REQUIREMENTS

This sections is being updated provide information on the IEC 60601-1, Third Edition.

'60601 and '80601 Medical Standards List, including those harmonized to the 3rd Edition of IEC 60601-1:
IEC 60601-1-XX, -2-XX Standards and Work in Progress
IEC 80601-2-XX Standards and Work in Progress
ISO 80601-2-XX Standards and Work in Progress
All three above links must be used to find all the applicable required '60601 and '80601 Standards (Base, Collaterals, and Particulars).
Be sure to check the "Standards under development" box in the ISO Standards list to get the standards not yet published.


The information remaining below covers the IEC 60601-1, Second Edition, which is is only valid for the US until June, 2013, and Europe and Canada until June, 2012. The rest of the nations have longer transition times. 


Designing Medical Electrical Equipment to Meet Safety Certification and Regulatory Requirements
(Covers the 2nd Ed. of IEC 60601-1 and UL 60601-1)

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