Canon TX-20 Full Auto Tonometer - Manual (Page 9)

2Safety
9
ISO 10993-1: 2009
ISO 10993-5: 2009
ISO 10993-10: 2010 Biological evaluation of medical devices – Evaluation and
testing
ISO 8612: 2001
ANSI Z80.10-2003 Ophthalmic instruments – Tonometers
European Union
93/42/EEC Medical Device Directive
EN 60601-1:2006 Medical electrical equipment - Part1:General requirements
for basic safety and essential performance
EN 60601-1-2: 2007 Medical electrical equipment – Part 1-2: Collateral standard:
Electromagnetic compatibility – Requirements and tests
EN 60601-1-6: 2010 Medical electrical equipment – Part 1-6: 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: 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: 2010 Biological evaluation of medical devices
ISO 8612: 2001 Ophthalmic instruments – Tonometers
L-IE-5191C_TX-20.indb 9 2013/07/18 13:10:10