Standards And Regulations - Vatech PaX-i3D Smart Installation Manual

1 Introduction
1.4

Standards and Regulations

A. Standards
This X-Ray equipment complies with the following standards:
IEC/EN/UL 60601-1, IEC/EN 60601-1-1, IEC/EN 60601-1-2, IEC/EN 60601-1-3, IEC/EN 60601-2-7,
IEC/EN 60601-2-28, IEC/EN 60601-2-32, IEC/EN 60601-2-44, ISO 9001, ISO 13485
The CE symbol indicates that this product complies with the European
Directive for Medical Devices 93/42/EEC as amended by 2007/47/EC as a
class IIb device.
B. Classification: (IEC60601-1 6.1)
Protection against the ingress of water: IEC60529 edition 2.1
Ordinary Equipment: IPX0
Protection against electric shock:
Class Ⅰ equipment, Type B Applied Parts
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Pax-i3D Smart(PHT-30LFO) Installation Manual