Gram Bioline Serie Mode D'emploi Original page 78

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:
EN 60601-1:2006
EN 60601-1-2:2015
EN 61010-1:2010
EN 61326-1:2013
EN IEC 61000-3-2:2019
EN 61000-3-3:2013
DIN 58345:2007
EN ISO 3744:2010
EN ISO 9001:2015
EN ISO 14001:2015
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. 005 – 14.1.2022
78 78
English EC Declaration of Conformity
BioCompact II (Accessorie code 69)
210, 310, 410, 210/210 & 310/210
R600a & R134a
Refrigerators and freezer for laboratory and biostorage
2022/02
Text:
Medical electrical equipment – Part 1: 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 disturbances – Requirements and tests
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1:
General requirements
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1:
General requirements
Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions
(equipment input current =16 A per phase)
Electromagnetic compatibility (EMC) – Part 3-3: Limits – Limitation of voltage changes, voltage
fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16
A per phase and not subject to conditional connection
Refrigerators for drugs – Definitions, requirements, testing
Acoustics – Determination of sound power levels and sound energy levels of noise sources using
sound pressure – Engineering methods for an essentially free field over a reflecting plane
Quality management systems – Requirements
Environmental management systems – Requirements with guidance for use