Gram Bioline Serie Mode D'emploi Original page 79

We, Gram Commercial declare under sole responsibility that the following products:
Range:
Model:
Refrigeration:
Product description:
Valid from (Year/Week):
To which this declaration relates, is in compliance with all the applicable essential requirements, and other provisions of t he 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:
Harmonized Standards: Text:
EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1:
General requirements
EN 60601-1:2006 Medical electrical equipment. General requirements for basic safety and essential performance
EN 60601-1-2:2015 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
DIN 58345:2007 Refrigerators for drugs – Definitions, requirements, testing
EN ISO 3744:2010 Acoustics – Determination of sound power levels of noise sources using sound pressure -
Engineering method in an essentially free field over a reflecting plane
EN ISO 9001:2015 Quality management systems
EN ISO 14001:2015 Enviroment management systems – Requirements with guidance for use
Gram Commercial
Aage Grams Vej 1
DK-6500 Vojens
Telephone: + 45 73 20 13 00
Vojens, 14.1.2022
John B. S. Petersen
Approval Manager
Rev. 006 – 14.1.2022
English EC Declaration of Conformity
BioCompact II (Accessorie code 69)
610
R600a, R290, R404A & R134a
Refrigerators and freezer for laboratory and biostorage
2022/02
b i o l i n e
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