Canon CR-2 AF Digital Non-Mydriatic Retinal Camera Manual
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2 Safety
IEC 62366: 2007
CAN/CSA-IEC 62366: 14
CAN/CSA-IEC 62366: 14
Medical devices - Application of usability engineering to
medical devices
medical devices
ISO 14971: 2007
Medical devices – Application of risk management to
medical devices
medical devices
ISO 10940: 2009
Ophthalmic instruments – Fundus cameras
European Union
93/42/EEC
Medical Device Directive
EN 60601-1: 2006+A11: 2011
Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
requirements for basic safety and essential performance
EN 60601-1-2: 2007
EN 60601-1-2: 2001+A1: 2006
EN 60601-1-2: 2001+A1: 2006
Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance
– Collateral standard: Electromagnetic compatibility –
Requirements and tests
requirements for basic safety and essential performance
– Collateral standard: Electromagnetic compatibility –
Requirements and tests
EN 60601-1-6: 2010
Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential performance
– Collateral standard: Usability
requirements for basic safety and essential performance
– Collateral standard: Usability
EN 62304: 2006
Medical device software – Software life cycle processes
EN 62366: 2008
Medical devices – Application of usability engineering to
medical devices
medical devices
EN ISO 14971: 2012
Medical devices – Application of risk management to
medical devices
medical devices
EN ISO 15004-1: 2009
Ophthalmic instruments – Part 1: General requirements
applicable to all ophthalmic instruments
applicable to all ophthalmic instruments
EN ISO 15004-2: 2007
Ophthalmic instruments – Part 2: Light hazard protection
EN ISO 10993-1: 2009/AC: 2010
EN ISO 10993-5: 2009
EN ISO 10993-10: 2010
EN ISO 10993-5: 2009
EN ISO 10993-10: 2010
Biological evaluation of medical devices
EN ISO 10940: 2009
Ophthalmic instruments – Fundus cameras
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