Product Manual

Vscan – User Manual i-1
GM092207 02
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 Vingmed Ultrasound. Ignoring this advice
may compromise the regulatory approvals obtained for the
product.
This product complies with the regulatory requirement of the
following:
Standard/Directive Scope
93/42/EEC Medical Devices Directive (MDD)
EN55011 Emitted noise according to Class B requirements
IEC60601-1
EN60601-1
UL60601-1
CAN/CSA-C22.2 No 601.1-M90
Medical Electrical Equipment, Part 1; General Requirements
for Safety
IEC60601-2-37 Medical electrical equipment - Part 2-37. Particular
requirements for the safety of ultrasonic medical diagnostic
and monitoring equipment
IEC1157 / EN61157 Requirements for the declaration of the acoustic output of
medical diagnostic ultrasonic equipment.
IEC60601-1-2
EN60601-1-2
Medical Electrical Equipment - part 1-2. Collateral standard:
Electromagnetic compatibility - Requirements and tests.
IEC60601-1-4
EN60601-1-4
Medical Electrical Equipment - part 1-4. Collateral standard:
Programmable electrical medical systems
IEC60601-1-6 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.
ISO10993-1 Biological evaluation of medical devices