Airssential Home LifeTemp Radient AI-RADTH Instrukcja obsługi - Strona 12
Przeglądaj online lub pobierz pdf Instrukcja obsługi dla Termometr Airssential Home LifeTemp Radient AI-RADTH. Airssential Home LifeTemp Radient AI-RADTH 20 stron. Non-contact thermometer
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Device Certifications
The LifeTemp Radient Thermometer is a Class IIa Medical Device. In compliance
0120
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
IS0 9001
ISO 14971
EN 60601-1
EN 60601-1-2
EN 60601-1-4
EN 12470-5
EN 980
EN 1041
ASTM E 1965 - 98 2003
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.
12
2003
Medical devices - Quality management system
– Requirements for Regulatory Purposes
2008
Quality systems - Model for quality assurance In
Design, Development, Production, Installation
and Servicing.
2007
Medical Devices - Application of Risk
Management to Medical Devices
1990/A13:1996 Medical electrical equipment
– Part 1: general Requirements for Safety
2007
Medical electrical equipment
– Part 1-2: general Requirements for Safety
– Collateral Standard: Electromagnetic
Compatibility
– Requirements and Tests
1996/A1:19M
Medical electrical equipment
– Part 1-4: general Requirements for Safety
– Collateral Standard: Programmable Electrical
Medical Systems
2003
Clinical Thermometers
– Part 5: Performance of Infrared ear
thermometers
2008
graphical Symbols for use in the
Labelling of Medical Devices.
2008
Information supplied by the manufacturer
of medical devices.
Standard Specification for Infrared
Thermometers for Intermittent Determination
of Patient Temperature