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CERTIFICATIONS AND STANDARDS
This product bears CE mark in accordance with the provisions of Council
Directive 93/42/ EC of June 14, 1993 on medical devices as amended by Directive
2007/47/EC of September 5, 2007.
The Intraoral Dental Digital Imaging Sensor, along with the components of his
system, have been evaluated and are conformed to the international EMC, safety and
quality standards listed below, among others:
EMC / Security
EN 60601-1: 2006 / A1: 2013 - Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance.
EN 60601-1-2: 2015 - Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests.
Usability
EN 60601-1-6: 2010 - Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral standard:
Usability
EN 62366: 2008 - Medical devices - Application of usability engineering to
medical devices.
Software
EN 62304: 2006 / AC: 2008 - Medical device software - Software life-cycle
processes.
Quality
EN ISO 13485: 2016 - Medical devices - Quality management systems -
Requirements for regulatory purposes
EN ISO 14971: 2012 - Medical devices - Application of risk management to
medical devices.
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