GE Typhoon 9200, Руководство по эксплуатации

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1 Introduction
1.2 Regulatory information
8
Typhoon Operating Instructions 28-9623-56 AA
International standards
CE marking
The CE marking and the corresponding Declaration of Conformity is valid for the
instrument when it is:
• used as a stand-alone unit, or
• connected to other CE-marked instruments, or
• connected to other products recommended or described in the user
documentation, and
• used in the same state as it was delivered from GE Healthcare, except for
alterations described in the user documentation or explicitly authorized by GE
Healthcare.
Regulatory compliance of
connected equipment
Any equipment connected to Typhoon should meet the safety requirements of EN
61010-1/IEC61010-1 or relevant harmonized standards. Within the European Union,
connected equipment must be CE-marked.
Standard Description Notes
EN 61010-1,
IEC 61010-1,
CAN/CSA-C22.2
no. 61010-1 Safety requirements for electrical
equipment for measurement,
control and laboratory use
EN 61326-1 EMC emissions and immunity
requirements for measurement,
control and laboratory use Harmonized with
2004/108/EC
EN-ISO 12100-1 Safety of machinery – Basic
concepts, general principles and
design Harmonized with
2006/42/EC
EN-ISO 14121-1,
14121-2 Safety of machinery – Principles of
risk assessment Harmonized with
2006/42/EC