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IEC 60601, iec 60601 - medical electrical equipment
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  #1  
Old 29th October 2008, 04:07 PM
MIREGMGR MIREGMGR is offline
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IEC 60601-1-3 2nd Edition (X-ray Radiation Protection)

Does anyone know of a certified lab that can certify conformity to this standard ?

Also possibly IEC 60601-1-6 Usability.

We are working with an OEM customer on development of one of their products, and a hospital where we want to do a test installation wants as many certifications of conformance as possible in order to feel comfortable letting this experimental Class I device be installed to the ceiling, over patients' and clinical staffs' heads, in a working OR.

Last edited by MIREGMGR; 29th October 2008 at 04:13 PM.

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Old 30th October 2008, 11:09 AM
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Coury Ferguson Coury Ferguson is offline
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Re: IEC 60601-1-3 2nd Edition (X-ray Radiation Protection)

Does anyone have a suggestion?

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Old 3rd February 2009, 01:20 AM
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Re: IEC 60601-1-3 2nd Edition (X-ray Radiation Protection)

Radiation shields are large barriers that are designed to block harmful x-ray radiation exposure. Despite many medical benefits that x-ray imaging provides, it is also a potentially dangerous process that can cause cancer or other medical complications unless the proper protection is utilized. Lead barriers are a useful tool in accomplishing radiation protection for many x-ray applications.

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Old 3rd February 2009, 02:10 AM
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Re: IEC 60601-1-3 2nd Edition (X-ray Radiation Protection)

Thanks, but I don't see the relevance of Thermo Fisher Electric's X-ray fluorescence identification of materials composition to the problem we're working on.

Among other things, our shielding isn't lead-based.

Other companies do make handheld X-ray flux measurement instrumentation, but we and our clinical-investigative site already have that capability.

What I'm seeking is a certified third party lab.
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Old 27th November 2009, 09:46 AM
mark walker mark walker is offline
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Re: IEC 60601-1-3 2nd Edition (X-ray Radiation Protection)

We are at present investigating 60601-1-3 issues but as far as 60601-1-6 is concerned you should be using 62366 concensus standard which replaces 60601-1-6
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