Braun ThermoScan PRO 6000 Directions For Use Manual page 29

EN 12470-5: 2003 Clinical thermometers – Part 5: Performance of infra-red ear thermometers
(with maximum device)
Meets CB Scheme
EN 60601-1-2 :2007, IEC 60601-1-2:2007 General requirements for basic safety and essential
performance—Collateral Standard: Electromagnetic Compatibility–Requirement & Tests
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic compatibility - Requirements and test
IEC 62304 :2006 Medical device software- Software life cycle processes
IEC 62366 :2007 (IEC60601-1-6) Medical devices -Application of usability engineering to
medical devices
EN980 :2008 Symbols for use in the labelling of medical devices
ISO14971 :2007 Medical devices -Application of risk management to medical devices
ISO 80601-2-56 :2009 Medical electrical equipment - Part 2-56: Particular requirements for basic
safety and essential performance of clinical thermometers for body temperature measurement
ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (includes
US FDA Blue book memo G95-1-100 Title)
GBT 21417.1:2008
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC. For detailed
description of EMC requirements please contact an authorized local Service Centre.
Portable and mobile RF communications equipment can affect MEDICAL
ELECTRICAL EQUIPMENT
Internally powered ME equipment.
Continuous operation.
Not protected against ingress of water.
IPX00
Symbol definitions:
BF APPLIED PART
Caution
This product contains batteries and
recyclable electronic waste. To protect
the environment, do not dispose of it
in the trash, but take it to appropriate
local collection points according to
national or local regulations.
Consult instructions
for use.
Measure icon
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