GE Vivid S70 User Manual page 4

Regulatory Requirements
Conformance Standards
Standard/Directive
93/42/EEC
2012/19/EU
2011/65/EU
IEC/EN 60601-1
ANSI/AAMI ES60601-1
CAN/CSA-C22.2 No. 60601-1
IEC/EN 60601-2-37
IEC/EN 60601-1-2
IEC/EN 60601-1-6
NEMA/AIUM UD-3
IEC/EN 62304
IEC/EN 62366
ISO 10993-1
i-2
The GE Healthcare product families are tested to meet all
applicable requirements and relevant standards per the
countries in which the product will be sold. Any changes to
accessories, peripheral units, or any other part of the system
must be approved by the manufacturer: GE Vingmed Ultrasound
AS. Ignoring this advice may compromise the regulatory
approvals obtained for the product.
This product complies with the regulatory requirements of the
following:
Medical Devices Directive (MDD)
Waste Electrical and Electronic Equipment (WEEE)
Directive on the restriction of the use of certain hazardous substances in
electrical and electronic equipment (ROHS)
Medical Electrical Equipment - Part 1. General requirements for basic
Safety and essential performance
Medical electrical equipment - Part 2-37. Particular requirements for the
basic safety and essential performance of ultrasonic medical diagnostic
and monitoring equipment
Medical Electrical Equipment - Part 1-2. General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
Medical Electrical Equipment - Part 1-6. General requirements for basic
safety and essential performance - Collateral standard: Usability
Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment.
Medical Device Software - Software life-cycle processes
Medical Devices - Application of usability engineering to medical devices
Biological evaluation of medical devices
Scope
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Vivid S70 / S60
BC092760-1EN 01
User Manual