Canon TX-20 Full Auto Tonometer 手册
2Safety
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ISO 10993-1: 2009
ISO 10993-5: 2009
ISO 10993-10: 2010
ISO 10993-5: 2009
ISO 10993-10: 2010
Biological evaluation of medical devices – Evaluation and
testing
testing
ISO 8612: 2001
ANSI Z80.10-2003
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
for basic safety and essential performance
EN 60601-1-2: 2007
Medical electrical equipment – Part 1-2: Collateral standard:
Electromagnetic compatibility – Requirements and tests
Electromagnetic compatibility – Requirements and tests
EN 60601-1-6: 2010
Medical electrical equipment – Part 1-6: Collateral standard:
Usability
Usability
EN 62304: 2006
Medical device software – Software life-cycle processes
EN 62366: 2008
Medical device – Application of usability engineering to
medical devices
medical devices
EN ISO 14971: 2009
Medical device – 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
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
EN ISO 10993-5: 2009
EN ISO 10993-10: 2010
Biological evaluation of medical devices
ISO 8612: 2001
Ophthalmic instruments – Tonometers
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