Canon CR-2 AF Digital Non-Mydriatic Retinal Camera Manuel

7

The following sections list the classifications applicable to the CR-2 AF and the directives and 
standards that the CR-2 AF complies with.

Protection against electric shock

Class I equipment

Degree of protection against electric shock

Type B applied parts (Chin 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

Not suitable

Mode of operation

Continuous operation

ANSI/AAMI ES 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

IEC 60601-1-2: 2001+A1: 2004
IEC 60601-1-2: 2007

Medical electrical equipment – Part 1-2: General 
requirements for safety – Collateral standard: 
Electromagnetic compatibility – Requirements and tests

IEC 60601-1-6: 2010
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

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

ISO 10993-1: 2009/Cor 1: 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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