Canon TX-20 Full Auto Tonometer - Manual (Page 8)

8
2
Safety
Regulatory Information
The following sections list the classifications applicable to the TX-20 and the directives and standards
that the TX-20 complies with.
Device Classification
Type of protection against electric shock Class I equipment
Degree of protection against electric shock Type B applied parts
(Chin rest, forehead rest)
Degree of protection against ingress of water IPX0
Degree of safety of application in the presence of a
flammable anaesthetic mixture with air or with oxygen or
nitrous oxide Not suitable
Mode of operation Continuous operation
Directives and Standards
USA and Canada
UL 60601-1:2003
CAN/CSA C22.2 No.601.1-M90
IEC 60601-1: 1988/A1: 1991/A2: 1995 Medical electrical equipment – Part 1: General requirements
for safety
IEC 60601-1:2005 Medical electrical equipment - Part1: General requirements
for basic safety and essential performance
IEC 60601-1-1: 2000 Medical electrical equipment – Part 1-1: General
requirements for safety – Collateral standard: Safety
requirements for medical electrical systems
IEC 60601-1-2: 2001/A1:2004
IEC 60601-1-2:2007 Medical electrical equipment – Part 1-2: Collateral standard:
Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4: 1996/A1: 1999 Medical electrical equipment – Part 1-4: Collateral standard:
Programmable electrical medical systems
IEC 62304: 2006 Medical device software – Software life-cycle processes
IEC 62366: 2007 Medical device – Application of usability engineering to
medical devices
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
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