GE Hot Lips Tube Sealer User Manual

HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI 7
Introduction 1
Regulatory information 1.2
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.
International standards
Requirement Content
Name and address of
manufacturer
GE Healthcare Bio-Sciences AB,
Björkgatan 30,
SE 751 84 Uppsala,
Sweden
Name and ID of notified body INTERTEK SEMKO AB, NB 0413
Standard Description Notes
EN 61010-1,
IEC 61010-1,
UL 61010-1,
CAN/CSA-C22.2 no.
61010-1
Safety requirements for
electrical equipment for
measurement, control and
laboratory use
EN harmonized with
2006/95/EC
EN 61326-1 EMC emissions and
immunity requirements for
measurement, control and
laboratory use
Harmonized with
2004/108/EC
EN ISO 12100:2010 Safety of machinery. General
principles for design. Risk
assessment and risk
reduction.
Harmonized with
2006/42/EC

GE Hot Lips Tube Sealer Specifications

General

Brand	GE
Model	Hot Lips Tube Sealer
Category	Medical Equipment
Language	English