eove EO-150 - Standards Compliance

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Standards compliance
The EO-150 meets the following standards:
EN ISO 14971: Medical Device Risk Management
IEC 60601-1 Ed3 (&CSA22.2): Medical Electrical Equipment –Part 1: General Requirements for Safety
1: Collateral Standard: Safety Requirements for Medical Electrical Systems
The ventilator is classified according to Chapter 5 of the norm CEI 60601-1, as follows:
Class II Equipment
Internally Powered Equipment
Type BF Applied Parts
IP22 with respect to access to hazardous parts and ingress of moisture
Not suitable for use in the presence of flammable anaesthetic mixtures
Not suitable for sterilisation
Suitable for continuous operation
Detachable power supply cable
IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
IEC 60601-1-6: Medical Electrical Equipment – Part 1-6: General requirements for basic safety and
essential performance – Collateral Standard – Usability
IEC 60601-1-8: Medical Electrical Equipment -Part 1-8: General requirements for basic safety and
essential performance : Tests and guidance for alarm systems in medical electrical equipment and
medical electrical systems.
CEI 60601-1-11: General requirements for basic safety and essential performance -- Collateral
standard: Requirements for medical electrical equipment and medical electrical systems used in the
home healthcare environment.
EN ISO 10651-2: Lung ventilators for medical use -- Particular requirements for basic safety and
essential performance -- Part 2: Home care ventilators for ventilator-dependent patients
ISO 80601-2-72: Medical electrical equipment -- Part 2-72: Particular requirements for basic safety
and essential performance of home healthcare environment ventilators for ventilator-dependent
patients