Canon TX-20 Full Auto Tonometer 手册

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The following sections list the classifications applicable to the TX-20 and the directives and standards 
that the TX-20 complies with.

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

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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