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7
2
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 Class I equipment
Degree of protection against electric shock Type B applied parts
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
CAN/CSA C22.2 No.601.1
IEC 60601-1: 1988+A1: 1991+A2: 1995
IEC 60601-1: 2005
Medical electrical equipment – Part 1: General
requirements for safety
IEC 60601-1-1: 2000 Medical electrical equipment – Part 1-1: General
requirements for safety – Collateral standard: Safety
requirements for medical electrical systems
IEC60601-1-2: 2001+A1: 2004 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
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
ISO 10993-5: 2009
ISO 10993-10: 2009
Biological evaluation of medical devices – Evaluation and
testing