19
LifeTemp
®
Non-Contact Thermometer
Device Certifications
0197
This 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:
ISO 80601-2-56:2017 Medical electrical equipment
– Part 2-56: Particular requirements for basic safety and
essential performance of clinical thermometers for body
temperature measurement.
EN12470-5:2003
Medical
electrical
equipment
– Part 2-56: Particular requirements for basic safety and
essential performance of clinical thermometers for body
temperature measurement.
IEC 60601-1:2005+A1:2012 Medical electrical equipment
– Part 1: general requirements for basic safety and
essential performance
IEC 60601-1-2:2014 (EMC) Medical electrical equipment
– Part 1 – 2: general requirements for basic safety
and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests.
