Monnal T60 Advanced - User manual
9.4 Regulatory requirements
Directives
Directive 93/42/EEC
Directive 2012/19/EU of the European Parliament and Council Directive concerning Waste Electrical
and Electronic Equipment (WEEE).
Date of CE marking for
Monnal T60 Advanced
: 2020.
Life time of the
Monnal T60 Advanced
ventilator: 10 years.
Standards
The compliance of
Monnal T60 Advanced
with the essential requirements of Directive 93/42 is based
on the following standards:
EN ISO 14971 Application of risk management to medical devices
IEC 60601-1 and its amendments | Electromedical devices – Part One: General requirements for safety
IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and es-
sential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safety and es-
sential performance - Collateral Standard: Usability
ISO 80601-2-12 | Medical electrical equipment - Part 2-12: Specific requirements for basic safety and
essential performance for pulmonary ventilators for use in intensive care
EN 794-3 + A2 | Pulmonary ventilators - Part 3: Specific recommendations for emergency and trans-
port ventilators
EN 1789 + A1 | Medical vehicles and their equipment - Road ambulances
EN 13718-1 | Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for med-
ical devices used in air ambulances
RTCA-DO160F – Environmental conditions and test procedures for airborne equipment. Sections 7, 8,
20 and 21
EN 62304 + A1 - Medical device software – Software life cycle processes
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