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Eurofins Product Service GmbH has updated its scope for medical devices

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The Certification Body scope for the National Certification Body and Certification Body Testing Laboratory Eurofins Product Service GmbH was updated. Following Medical electrical Device standards for Safety were added to the scope.

Medical Devices

Reference

Title

IEC 60601-1-9:2007

IEC 60601-1-9:2007/AMD1:2013

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design.

IEC 60601-1-10:2007

IEC 60601-1-10:2007/AMD1:2013

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers.

IEC 60601-1-12:2014

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.

IEC 80601-2-60:2012

Medical electrical equipment - Part 2-60: Particular requirements for basic safety and essential performance of dental equipment.