Canon CR-2 Manuale operativo - Pagina 7
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Safety
Regulatory Information
The following sections list the classifications applicable to the CR-2 and the directives and standards
that the CR-2 complies with.
Device Classification
Protection against electric shock
Degree of protection against electric shock
Degree of protection against ingress of water
Degree of safety of application in the presence of a
flammable anaesthetic mixture with air or with oxygen or
nitrous oxide
Mode of operation
Directives and Standards
USA and Canada
UL 60601-1
CAN/CSA C22.2 No.601.1
IEC 60601-1: 1988/A1: 1991/A2: 1995
IEC 60601-1-1 Ed. 2.0: 2000
IEC 60601-1-2: Ed. 2.1: 2004
IEC 60601-1-4: Ed. 1.1: 2000
ISO 15004-1: 2006
ISO 15004-2: 2007
ISO 10993-1: 2003
ISO 10993-5: 1999
ISO 10993-10: 2002/A1: 2006
Class I equipment
Type B applied parts
IPX0
Not suitable
Continuous operation
Medical electrical equipment – Part 1: General requirements
for safety
Medical electrical equipment – Part 1-1: General
requirements for safety – Collateral standard: Safety
requirements for medical electrical systems
Medical electrical equipment – Part 1-2: Collateral standard:
Electromagnetic compatibility – Requirements and tests
Medical electrical equipment – Part 1-4: Collateral standard:
Programmable electrical medical systems
Ophthalmic instruments – Part 1: General requirements
applicable to all ophthalmic instruments
Ophthalmic instruments – Part 2: Light hazard protection
Biological evaluation of medical devices – Evaluation and
testing
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