Esaote MyLab, Руководство оператора

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M y L a b – S A F E T Y A N D S T A N D A R D
3-2
Standards Summary Table
Standard Title
EN60601-1 Medical Electrical Equipment – General requirements for Safety
EN60601-2-37 Medical Electrical Equipment – Particular requirements for the
safety of ultrasonic medical diagnostic and monitoring
equipment
EN60601-1-2 Medical Electrical Equipment – General requirements for Safety
– Electromagnetic compatibility – Requirements and Test
EN60601-1-1 Medical Electrical Equipment – General requirements for Safety
- Safety requirements for medical electrical systems -
requirements and tests
EN ISO 10993-1 Biological evaluation of medical devices – Guidance on
selection of tests
EN61157 Requirements for the declaration of the acoustic output of
medical diagnostic ultrasonic equipment
AIUM/NEMA UD-3 Standard for Real Time Display of Thermal and Mechanical
Acoustic Output Indices on Diagnostic Ultrasound Equipment
Acoustic Output
MyLab
acoustic output complies with the requirements of FDA Track 3 guidance.
Peripherals Standard Requirements
When peripherals are connected to an ultrasound system, they become part of a
medical system. Therefore they must comply with the below mentioned standards
to maintain the overall system conformity.
Safety
Your device must:
meet the EN60601-1 OR in accordance with EN60601-1-1:

the device must meet the applicable safety standards for its
category;

the device must be powered through an isolation transformer
designed for medical applications
If your configuration is equipped with the cart, the isolation
transformer requirement is fulfilled by powering the device
through one of the cart’s insulated plugs.
Electromagnetic Compatibility
Your peripheral device must:

meet the EN55011 or 55022 emission limits, according to the
environment where the system is used;

meet the EN50082-1 or EN61000-6-1 immunity requirements