i-4 Vscan Air – User Manual
Direction GP092020-1EN
Rev 18
Regulatory Requirements
Conformance Standards
The GE Healthcare (GEHC) product families are tested to meet
all applicable requirements in relevant EU Directives and
European/International standards. Any changes to accessories,
peripheral units or any other part of the device must be
approved by the manufacturer. Ignoring this advice may
compromise the regulatory approvals obtained for the product.
This product complies with the regulatory requirement of the
following:
Table i-1: Regulatory requirements
Standard/Directive Scope
93/42/EEC Medical Devices Directive (MDD)
The CE label affixed to the product testifies compliance to
the Directive. The location of the CE marking is shown in the
Safety chapter of this manual.
Year of first CE mark: 2020
2014/53/EU Radio Equipment Directive (RED)
2011/65/EU
including 2015/863/EU Annex II
Directive on the restriction of the use of certain hazardous
substances in electrical and electronic equipment (ROHS)
2012/19/EU Waste Electrical and Electronic Equipment (WEEE)
EN55011 Industrial, scientific and medical equipment -
Radio-frequency disturbance characteristics - Limits and
methods of measurement
IEC* 60601-1
CAN/CSA-C22.2 No 601.1
Medical Electrical Equipment, Part 1; General Requirements
for Safety
IEC* 60601-2-37 Medical electrical equipment - Part 2-37. Particular
requirements for the safety of ultrasonic medical diagnostic
and monitoring equipment
IEC* 60601-1-2 Medical Electrical Equipment - part 1-2. Collateral standard:
Electromagnetic compatibility - Requirements and tests.
IEC* 60601-1-6 Medical Electrical Equipment - part 1-6. Collateral standard:
Usability.
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