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18. Legal requirements and guidelines
Thermoval baby complies with the European regulations which are based on the
93/42/EEC Medical Device Directive (MDD) and bears the CE mark.
The device is compliant, among others, with the guidelines of the European
Standard for Medical Thermometers DIN EN ISO 80601-2-56 and the relevant
requirements of DIN EN 12470-5.
Thermoval baby is compliant with:
DIN EN IEC 60601-1: "Medical electrical equipment - General requirements for
basic safety and essential performance" and DIN EN IEC 60601-1-2: "Collateral
Standard: Electromagnetic compatibility - requirements and tests".
ELECTRICAL MEDICAL DEVICES require special precautionary measures with re-
gard to electromagnetic compatibility (EMC). The use of this device in the vicinity
of portable mobile high-frequency communication devices or other devices with
strong electromagnetic fields can adversely affect its operation. In compliance
with European Standard DIN EN IEC 60601-1-2 further information can be
supplied by HARTMANN on request.
Thermoval baby is compliant with the European Directive 2011/65/EU on the
restriction of the use of certain hazardous substances in electrical and electronic
equipment.
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