Radio Shack 2200245 - Applicable Standards

15
14. Applicable Standards
The manufacturer declares that this device complies with the following
applicable standards.
EN 980
Symbols for use in the labeling of medical devices
EN 1041
Information supplied by the mfg. with medical devices
EN 60601-1
Medical electrical equipment, Part 1: General
requirements for basic safety and essential performance
EN 60601-1-2
Medical electrical equipment, Part 1-2: General
requirements for basic safety and essential performance
Collateral standard: Electromagnetic compatibility -
Requirements and tests
EN 60601-1-6
Medical electrical equipment, Part 1-6: General
requirements for basic safety and essential performance
Collateral standard: Usability
EN 60601-1-11
Medical electrical equipment, Part 1-11: General
requirements for basic safety and essential performance
Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in a
home healthcare environment
EN 12470-5
Clinical thermometers ‒ Part 5: Performance of infra-red
ear thermometers (with maximum device)
ISO 80601-2-56
Medical electrical equipment, Part 2-56: particular
requirements for basic safety and essential performance
of clinical thermometers for body temperature
measurement
EN 62304
Medical device software - Software life-cycle processes
EN 62366
Medical devices - Application of usability engineering to
medical devices
EN ISO 10993-1
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
ATSM E 1965-98
Standard specication for infrared thermometers for
intermittent determination of patient temperature