Applicable Standards - Scaleo medical Horizon S5 Manual Del Usuario

Applicable standards

This device is designed to conform to the following standards:
•
IEC 60601-1：2012,
essential performance.
•
IEC 60601-1-2:2014, 2nd edition, Medical electrical equipment, part 1-2: General requirement for safety –
Collateral standard: Electromagnetic compatibility – Requirements and tests.
•
IEC 60601-1-8：2012, Medical electrical equipment - part 1-8: General requirements for basic safety and
essential performance - Collateral standard: General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems + Amendment 1:2012.
•
IEC 60601-1-11：2015, 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 the home healthcare environment.
•
BS EN ISO 80601-2-69: 2014,
safety and essential performance of oxygen concentrator equipment.
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Medical electrical equipment, part 1: General requirements for basic safety and
Medical electrical equipment, part 2-69: Particular requirements for basic
DOMU119_EN-FR-ES-RU-DE_v4_20230105_ Horizon® S5