YY 9706.112-2021 Medical electrical equipment—Part 1-12:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

Scope

This part specifies the basic safety and basic performance requirements for medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems) intended for use in emergency medical service environments.
This part applies to ME equipment and ME systems intended for use in emergency medical service environments (hereinafter referred to as EMS environments) as specified in the manufacturer's user manual.
Note 1: For the purposes of this standard, the manufacturer's intended use is specified in the user manual. Responsible parties and operators must be aware that any use beyond the manufacturer's intended use may pose a risk to patients.
EMS environments include:
—— Providing treatment and life support to injured or ill patients who have not yet been transported to hospitals at the scene of emergencies, and transporting patients to appropriate professional medical institutions for further care while providing continuous life support care.
—— Providing monitoring, treatment, or diagnosis during the transfer process between professional medical institutions.
This part does not apply to ME equipment and ME systems that are only used in home care environments in accordance with YY9706.111, or only used in professional medical institutions in accordance with GB9706.1 (but not in accordance with YY9706.111 or this part). ME equipment and ME systems are generally not used in only one environment. These ME equipment or ME systems may be used in multiple environments, so if they can also be used in EMS environments, they are included in the scope of application of this standard.
Example: ME equipment or ME systems that can be used in both EMS environments and professional medical institution environments.
Note 2: ME equipment and ME systems for EMS environments can be used in places with unstable power supply and outdoor environmental conditions.
Note 3: The chapters and artic

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