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IEC 60601-1 3rd Edition adoption - I cant find this standard on the ISO page - Page 2


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iec 60601 - medical electrical equipment, iso 14971 - medical device risk management
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  Post Number #9  
Old 5th December 2011, 06:01 PM
didsy

 
 
Total Posts: 4
Re: IEC 60601-1 3rd Edition adoption - I cant find this standard on the ISO page

Hi Bassman84,

I think the 60601-1 refers out to EN61326-1:2006 (Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements), with specific requirements for in-vitro diagnostic equipment contained in EN61326-2-6, and transducers with integrated or remote signal conditioning covered by EN 61326-2-3.

I will look what we did last time for a client with a centrifuge and get back to you tomorrow.

PS Sargans is well positioned for Flumserberg - nice place.

Last edited by didsy; 5th December 2011 at 06:25 PM.

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  Post Number #10  
Old 9th July 2012, 01:33 PM
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Watchwait

 
 
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Re: IEC 60601-1 3rd Edition adoption - I cant find this standard on the ISO page

How does the fact that Switzerland is not in the EU impact 3rd Ed. requirements? Should they be considered that same as other EU countries, or not? I need some specific regulatory reference about Switzerland & 3rd Ed deadlines (or not!) to move forward with our comformance program... Thanks!
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