Canon CR-2 PLUS AF - Manual (Page 7)

7
2
Safety
Regulatory Information
The following sections list the classifications applicable to the CR-2 Plus AF and the directives and
standards that the CR-2 Plus 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)
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: 2003
CAN/CSA C22.2 No.601.1-M90
IEC 60601-1: 1988+A1: 1991+A2: 1995
Medical electrical equipment – Part 1: General
requirements for safety
ANSI/AAMI ES 60601-1:2005
CAN/CSA-C22.2 No.60601-1-08
Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance
IEC 60601-1: 2005
IEC 60601-1-1: 2000 Medical electrical equipment – Part 1-1: General
requirements for safety – Collateral standard: Safety
requirements for medical electrical systems
IEC 60601-1-2: 2001+A1: 2004 Medical electrical equipment – Part 1-2: General
requirements for safety – Collateral standard:
Electromagnetic compatibility – Requirements and tests
IEC 60601-1-2: 2007 Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance
– Collateral standard: Electromagnetic compatibility –
Requirements and tests
IEC 60601-1-4: 1996+A1: 1999 Medical electrical equipment – Part 1-4: General
requirements for safety – Collateral standard:
Programmable electrical medical systems