Scaleo medical Horizon S5, Руководство пользователя

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30 DOMA119_v5_20200629_ Ho
2
rizon® S5
Applicable standards
T his device is designed to conform to the following standards:

IEC 60601-1
：
2012, Medical electrical equipment, part 1: General requirements for basic safety
and 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, Medical electrical equipment, part 2-69: Particular requirements
for basic safety and essential performance of oxygen concentrator equipment.