Filter
Top Products
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
Medical electrical equipment – Part 1: General requirements
for safety
IEC 60601-1-1 Ed. 2.0: 2000 Medical electrical equipment – Part 1-1: General
requirements for safety – Collateral standard: Safety
requirements for medical electrical systems
IEC 60601-1-2: Ed. 2.1: 2004 Medical electrical equipment – Part 1-2: Collateral standard:
Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4: Ed. 1.1: 2000 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: 2003
ISO 10993-5: 1999
ISO 10993-10: 2002/A1: 2006
Biological evaluation of medical devices – Evaluation and
testing