GE Vscan Extend User Manual page 5

Regulatory Requirements
Conformance Standards
Standard/Directive
93/42/EEC
EN55011
IEC* 60601-1
CAN/CSA-C22.2 No 601.1
IEC* 60601-2-37
IEC* 60601-1-2
IEC* 60601-1-4
IEC* 60601-1-6
NEMA/AIUM UD-3
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Vscan Extend User Manual
5721203-100 Rev. D
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
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.
Industrial, scientific and medical equipment -
Radio-frequency disturbance characteristics - Limits and
methods of measurement
Medical Electrical Equipment, Part 1; General Requirements
for Safety
Medical electrical equipment - Part 2-37. Particular
requirements for the safety of ultrasonic medical diagnostic
and monitoring equipment
Medical Electrical Equipment - part 1-2. Collateral standard:
Electromagnetic compatibility - Requirements and tests.
Medical Electrical Equipment - part 1-4. Collateral standard:
Programmable electrical medical systems
Medical Electrical Equipment - part 1-6. Collateral standard:
Usability.
Standard for real-time display of thermal and mechanical
acoustic output indices on diagnostic ultrasound equipment.
Scope
i-3