The CISPR edition that is referenced in IEC 60601-1-2:2014 is "edition 5.1, including CISPR 11:2009 and its Amendment 1:2010". The CISPR referenced is a consolidated version of that standard.
This information about the CISPR 11 standard is located in the normative references - Clause 2 of the IEC 60601-1-2:2014 standard.
Hope this helps,
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email:
Leo@EisnerSafety.comWebsite:
www.EisnerSafety.com------------------------------
Original Message:
Sent: 15-Nov-2018 02:40
From: Mike Kilkelly
Subject: IEC 60601-1-2 (4th Edition) and CISPR11 versions
Hi
Can anyone help me understand which version of CISPR 11, FDA will require for compliance to IEC 60601-1-2 - 4th Edition.
IEC 60601-1-2 is an FDA recognized consensus standard and references CISPR 11 throughout, but CISPR 11 is not listed in the the recognized consensus standard database.
I believe the most recent edition is CISPR 11:2015+AMD1:2016 CSV
Grateful for any help with this.
regards
Mike
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Mike Kilkelly
Quality Manager
Galway
Ireland
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