EN 60601-1:2006/A1:2013: (3rd edition) Medical electrical equipment – Part 1
General requirements for basic safety and essential performance
Type of Protection: Class 1
EN 60601-1-2:2007/AC2010: Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance – Collateral standard:
Electromagnetic compatibility – Requirements and tests
EN 60601-1-8:2007/AC 2010: Medical electrical equipment - Part 1-8:
General requirements for basic safety and essential performance - Collateral
Standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
EN ISO 14971:2012: Medical devices – Application of risk management to medical
devices
IEC 62304:2006 Medical device software – Software life cycle processes
EN 1041:2008: Information supplied by the manufacturer of medical device
EN ISO 80601-2-61:2011: Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance of pulse oximeter
equipment
ISO 10993-1:2009: Biological evaluation of medical d evices – Part 1:
Evaluation and testing within a risk management process
EN ISO 15223-1:2012: Medical devices – Symbols to be us ed with medical device
labels, labeling and information to be supplied – Part 1: General requirements
EN 980:2008: Symbols for use in the labelling of medical devices
2011/65/EU
2012/19/EU
Compliance
Electrical Safety
Electromagnetic Compatibility
Performance
RoHS
WEEE
Specications
Explanation of Symbols
This statement provides important
information or highlights information that
may be easily overlooked.
This statement is a warning. Not following
this statement could result in injury to the
patient or operator, or damage to the device.
Defribrillation-proof type BF
applied part.
2265
Do not disassemble the device unless you
are an MTTS trained technician or have been
Refer to the user manual before operating
this device.
Refer to the user manual before operating
this device.
This device contains electronic parts. Do not
dispose of it with normal waste. Dispose of
it according to local guidelines for disposal
of eletronics. Dispose according to the WEEE
directive in the European Union.
Name and address of European
Authorized Representative.
Device manufacturer.
Date of manufacture.
Serial number.
Type and full rating of fuse.
IPX1
Liquid ingress protection - level 1
(dripping water).
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