Canon CR-2 PLUS AF - Manual (Page 9)

2 Safety
9
EN 60601-1-6: 2010 Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential performance
– Collateral standard: Usability
EN 62304: 2006 Medical device software – Software life-cycle processes
EN 62366: 2008 Medical device – Application of usability engineering to
medical devices
EN ISO 14971: 2012 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
EN 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: 2010
Biological evaluation of medical devices – Evaluation and
testing