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Standards compliance
The EO-70 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 device 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
Non continuous operation (50%)
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
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.
Cybersecurity contact
If you believe you have discovered a vulnerability or have a security incident to report, please
contact us at security@eove.fr .
Use this email for all information security incidents to ensure they are correctly captured and
handled in a timely manner. If you have discovered a security concern, we will work with you to
make sure that we understand the scope of the issue and that we address the exposure.
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