Canon CR-2 PLUS AF - Manual (Page 8)

8
2 Safety
IEC 60601-1-6: 2010 Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential performance
– Collateral Standard: Usability
ISO 15004-1: 2006 Ophthalmic instruments – Part 1: General requirements
applicable to all ophthalmic instruments
ISO 15004-2: 2007 Ophthalmic instruments – Part 2: Light hazard protection
ISO 10993-1: 2009
ISO 10993-5: 2009
ISO 10993-10: 2010
Biological evaluation of medical devices – Evaluation and
testing
IEC 62304: 2006 Medical device software - Software life cycle processes
IEC 62366: 2007 Medical device - Application of usability engineering to
medical devices
European Union
93/42/EEC Medical Device Directive
EN 60601-1: 2006 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
EN 60601-1: 1990+A1: 1993+A2:1995 Medical electrical equipment – Part 1: General
requirements for safety
EN 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: 2001+A1: 2006 Medical electrical equipment – Part 1-2: General
requirements for safety – Collateral standard:
Electromagnetic compatibility – Requirements and tests
EN 60601-1-2: 2007 Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance
– Collateral standard: Electromagnetic compatibility –
Requirements and tests
EN 60601-1-4: 1996+A1: 1999 Medical electrical equipment – Part 1-4: General
requirements for safety – Collateral standard:
Programmable electrical medical systems