Canon CR-2 - Manual (Page 8)

8
2 Safety
European Union
93/42/EEC Medical Device Directive
EN 60601-1: 1990+A1: 1993+A2: 1995
EN 60601-1: 2006
Medical electrical equipment – Part 1: General
requirements for safety
IEC 60601-1-1: 2001 Medical electrical equipment – Part 1-1: General
requirements for safety – Collateral standard: Safety
requirements for medical electrical systems
EN 60601-1-2: 2007 Medical electrical equipment – Part 1-2: Collateral
standard: Electromagnetic compatibility – Requirements
and tests
IEC60601-1-4: 1996+A1: 1999 Medical electrical equipment – Part 1-4: General
requirements for safety – Collateral standard:
Programmable electrical medical systems
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: 2009 Medical device – Application of risk management to
medical devices
EN ISO 15004-1: 2009 Ophthalmic instruments – Part 1: General requirements
applicable to all ophthalmic instruments
ISO 15004-2: 2007 Ophthalmic instruments – Part 2: Light hazard protection
EN ISO 10993-1: 2009
EN ISO 10993-5: 2009
EN ISO 10993-10: 2009
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.