Professional LED Light System for All of Surgery Application
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1. Standard
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Certification of DENTIS
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ISO 9001:2008
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EN ISO 13485:2012
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Relevant EC Directives: 93/42/EEC Medical Device Directive as amended by
2007/47/EC, Annex I and Annex VII.
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Applied Standards:
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EN ISO 15223-1:2012, Medical devices – Symbols to be used with medical device
labels, labelling and information to be supplied
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EN 1041:2008, Information supplied by the manufacturer with medical devices
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EN ISO 13485:2012, Medical devices – Quality management systems – Requirements
for regulatory purpose
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EN ISO 14971:2012, Medical devices – Application of risk management to medical
devices
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IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General
requirements for safety
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EN 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements
for safety - Collateral standard: Electromagnetic compatibility – Requirements and
tests
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EN 60601-1-6:2010, Medical electrical equipment-Part 1-6: General requirements for
safety – Collateral Standard: Usability
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EN ISO 7010:2012, Graphical symbols – Safety colors and safety signs-Registered
safety signs
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EN 62471:2008, Photo biological safety of lamps and lamps systems
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EN 62366:2008, Medical devices – Application of usability engineering to medical
devices
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IEC 60601-2-41:2009, Medical electrical equipment – Part 2-41: Particular
requirements for the basic safety and essential performance of surgical luminaires
and luminaires for diagnosis
•
IEC 62133:2012, Secondary cells and batteries containing alkaline or other non-acid
electrolytes – Safety requirements for portable sealed secondary cells, and for
batteries made from them, for use in portable applications
•
IEC 62304:2006, Medical device software, Software life-cycle processes
