12
Device Certifications
The LifeTemp Radient Thermometer is a Class IIa Medical Device. In compliance
with the European standard, this device bears the CE conformity mark of the
Medical Devices Directive and complies with the following reference standards:
IS0 13485
2003
Medical devices - Quality management system
– Requirements for Regulatory Purposes
IS0 9001
2008
Quality systems - Model for quality assurance In
Design, Development, Production, Installation
and Servicing.
ISO 14971
2007
Medical Devices - Application of Risk
Management to Medical Devices
EN 60601-1
1990/A13:1996 Medical electrical equipment
– Part 1: general Requirements for Safety
EN 60601-1-2
2007
Medical electrical equipment
– Part 1-2: general Requirements for Safety
– Collateral Standard: Electromagnetic
Compatibility
– Requirements and Tests
EN 60601-1-4
1996/A1:19M
Medical electrical equipment
– Part 1-4: general Requirements for Safety
– Collateral Standard: Programmable Electrical
Medical Systems
EN 12470-5
2003
Clinical Thermometers
– Part 5: Performance of Infrared ear
thermometers
EN 980
2008
graphical Symbols for use in the
Labelling of Medical Devices.
EN 1041
2008
Information supplied by the manufacturer
of medical devices.
ASTM E 1965 - 98 2003
Standard Specification for Infrared
Thermometers for Intermittent Determination
of Patient Temperature
This thermometer complies with the RoHS (Restriction of the use of certain
Hazardous Substances) Directives 2002/95/EC and 2002/96/EC of the European
Parliament, 2003. These directives restrict the marketing of electronic equipment
containing heavy metals or compounds and set standards for the disposal of
Waste Electrical and Electronic Equipment (WEEE) to lessen the impact on our
health and the environment.
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