Canon CR-2 AF Digital Non-Mydriatic Retinal Camera 매뉴얼
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Safety
Regulatory Information
The following sections list the classifications applicable to the CR-2 AF and the directives and
standards that the CR-2 AF complies with.
standards that the CR-2 AF complies with.
Device Classification
Protection against electric shock
Class I equipment
Degree of protection against electric shock
Type B applied parts (Chin rest
and forehead rest)
and 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
flammable anaesthetic mixture with air or with oxygen or
nitrous oxide
Not suitable
Mode of operation
Continuous operation
Directives and Standards
USA and Canada
ANSI/AAMI ES 60601-1: 2005
CAN/CSA-C22.2 No.60601-1: 08
IEC 60601-1: 2005
CAN/CSA-C22.2 No.60601-1: 08
IEC 60601-1: 2005
Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance
requirements for basic safety and essential performance
IEC 60601-1-2: 2001+A1: 2004
IEC 60601-1-2: 2007
IEC 60601-1-2: 2007
Medical electrical equipment – Part 1-2: General
requirements for safety – Collateral standard:
Electromagnetic compatibility – Requirements and tests
requirements for safety – Collateral standard:
Electromagnetic compatibility – Requirements and tests
IEC 60601-1-6: 2010
CAN/CSA-C22.2 No.60601-1-6: 11
CAN/CSA-C22.2 No.60601-1-6: 11
Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential performance
– Collateral Standard: Usability
requirements for basic safety and essential performance
– Collateral Standard: Usability
ISO 15004-1: 2006
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
ISO 10993-1: 2009/Cor 1: 2010
ISO 10993-5: 2009
ISO 10993-10: 2010
ISO 10993-5: 2009
ISO 10993-10: 2010
Biological evaluation of medical devices
IEC 62304: 2006
Medical device software - Software life cycle processes
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