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2 Safety
European Union
93/42/EEC Medical Device Directive
EN 60601-1 Ed. 3.0: 2006 Medical electrical equipment – Part 1: General requirements
for safety
EN 60601-1-2: 2007 Medical electrical equipment – Part 1-2: Collateral standard:
Electromagnetic compatibility – Requirements and tests
EN 60601-1-6: 2004 Medical electrical equipment – Part 1-6: General
requirements for safety – Collateral standard: Usability
IEC 62304: 2006 Medical device software – Software life-cycle processes
EN 62366: 2008 Medical device – Application of usability engineering to
medical devices
EN ISO 14971: 2007 Medical device – Application of risk management to
medical devices
EN ISO 15004-1: 2006 Ophthalmic instruments – Part 1: General requirements
applicable to all ophthalmic instruments
EN ISO 15004-2: 2007 Ophthalmic instruments – Part 2: Light hazard protection
EN ISO 10993-1: 2003
EN ISO 10993-5: 1999
EN ISO 10993-10: 2002/A1: 2006
Biological evaluation of medical devices – Evaluation and
testing
Deutschland
Während des Betriebs liegt der Schalldruckpegel dieses Instruments bei 70 dB(A) oder weniger
gemäß EN ISO 7779.
