83
b i o l ine
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Rev. 008 – 12.04.2023
English EC Declaration of Conformity
We, Gram Scientific ApS declare under sole responsibility that the following products:
BioCompact II (Accessorie code 69)
R600a, R290, R404A & R134a
Refrigerators and freezer for laboratory and biostorage
To which this declaration relates, is in compliance with all the applicable essential requirements, and other provisions of the European
Council Directive and regulations.
Directives and Regulations of the European Parliament and of the Council:
Machinery Directive 2006/42/EC
- Pressure Equipment Directive 2014/68/EU
- Low Voltage Directive 2014/35/EU
- EMC Directive 2014/30/EU
- RoHS Directive 2011/65/EU
- REACH EC No.1907/2006
- F-Gas Regulation (EU) No 517/2014
Product compliance has been demonstrated on the basis of:
Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1:
General requirements
Medical electrical equipment. General requirements for basic safety and essential performance
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Refrigerators and freezers for laboratory and medical applications – Terminology, requirements,
testing
Acoustics – Determination of sound power levels of noise sources using sound pressure -
Engineering method in an essentially free field over a reflecting plane
Quality management systems
Enviroment management systems – Requirements with guidance for use
Gram Scientific ApS
Aage Grams Vej 1
DK-6500 Vojens
Denmark
Telephone: + 45 73 20 13 00
Vojens, 12.04.2023
John B. S. Petersen
Approval Manager
BioCompact II 610 –
Accessories code 69
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