\\Server1\data\QA\Manualer\Arkiv\Manuals- Labogene-Origio-GKO\Declarations\ScanLaf\word\Declaration-Mars-Mars-PRO-Orion-
MSC1-Sirius-rev.-6.docx
Declaration of Conformity
We declare under our responsibility, that the following product:
Model: Mars, Mars PRO 900, 1200, 1500, 1800
Orion 1200, 1500, 1800 - MSC1 - Sirius
to which this declaration relates is in conformity with the following standard(s) directives or other
normative document(s):
In compliance with:
EN 12469: 2000 Biotechnology - Performance criteria for microbiological safety cabinets
DIN 12980 For Cytotoxic Cabinets
DIN 14644 Cleanrooms and associated controlled environments
EN ISO 12100-1: 2003 Safety of machinery
(basic concepts – General principles)
EN ISO 12100-2: 2003 Safety of machinery
(Technical principles and specifications)
EN 60204-1: 2006 Safety of machinery
(Electrical equipment of machines – General requirements)
EN 61010-1: 2001 Safety requirements for electrical equipment for measurement, control and
laboratory use. General requirements
EN 61000-6-3: 2007, EN 61000-6-1: 2002
Electromagnetic compatibility
(Generic immunity/emission standard)
EN ISO 14121-1: 2007 Safety of machinery
Risk assessment - Part 1: Principles
GMP Good Manufacturing Practice
EN ISO 11201 – Acoustics – Noise emitted by machinery and equipment
following the provisions of:
EU Medical Devices Directive 93/42/EEC
Directive 2006/42/CE Machinery safety
Directive 2006/95/EEC, per August 2007
(Electrical equipment designed for use within certain voltage limits)
Directive 2004/108/EEC EMC Electromagnetic compatibility
Lynge, June 2011
Finn Kokholm
Managing Director
LaboGene ApS, Industrivej 6-8, Vassingerød, 3540 Lynge, Denmark
