Vscan Extend – User Manual i-3
5721203-100 Rev. D
Regulatory Requirements
Conformance Standards
The GE 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 system must be approved by the
manufacturer: GE Medical Systems. 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)
2007/47/EC (MDD amendment)
Directive 2011/65/EU RoHS
2002/96/EC WEEE
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.
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* 60601-1-4 Medical Electrical Equipment - part 1-4. Collateral standard:
Programmable electrical medical systems
IEC* 60601-1-6 Medical Electrical Equipment - part 1-6. Collateral standard:
Usability.
NEMA/AIUM UD-3 Standard for real-time display of thermal and mechanical
acoustic output indices on diagnostic ultrasound equipment.
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