Regulatory Information - GE Hot Lips Tube Sealer Operator's Manual

1.2

Regulatory information

This section lists the directives and standards that are fulfilled by HOT LIPS TUBE
SEALER.
Manufacturing information
The table below summarizes the required manufacturing information. For further
information, see the EC Declaration of Conformity document.
Requirement
Name and address of
manufacturer
Name and ID of notified body
International standards
Standard
EN 61010-1,
IEC 61010-1,
UL 61010-1,
CAN/CSA-C22.2 no.
61010-1
EN 61326-1
EN ISO 12100:2010
HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI
Content
GE Healthcare Bio-Sciences AB,
Björkgatan 30,
SE 751 84 Uppsala,
Sweden
INTERTEK SEMKO AB, NB 0413
Description
Safety requirements for
electrical equipment for
measurement, control and
laboratory use
EMC emissions and
immunity requirements for
measurement, control and
laboratory use
Safety of machinery. General
principles for design. Risk
assessment and risk
reduction.
Introduction 1
Regulatory information 1.2
Notes
EN harmonized with
2006/95/EC
Harmonized with
2004/108/EC
Harmonized with
2006/42/EC
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