SPECIFICATIONS
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EN 980
Symbols for use in the labeling of medical devices.
EN 1041
Information supplied by the manufacturer with
medical devices.
EN 12470-5
Clinical thermometers – Part 5: Performance of
infra-red ear thermometers (with maximum device)
ASTM E1965
Standard Specification for Infrared Thermometer for
Intermittent Determination of Patient Temperature.
EN 60601-1
EN 60601-1-2
Medical electrical equipment Part 1: General
requirements for basic safety and essential
performance.
Medical electrical equipment – Part1-6: General
requirements for basic safety and essential
performance – Collateral standard: Usability
Medical electrical equipment -- Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests.
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 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 home healthcare environment.
EN 60601-1-6