Gram bioline BioCompact II User Manual

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Declaration of conformity
Rev. 006 – 13.12.2022
English EC Declaration of Conformity
We, Gram Scientific ApS declare under sole responsibility that the following products:
Range:
BioCompact II
Model:
210, 310, 410, 210/210 & 310/210
Refrigeration:
R600a & R134a
Product description:
Refrigerators and freezer for laboratory and biostorage
Valid from (Year/Week):
2023/01
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
- ATEX Directive 2014/34/EU
- 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 60601-1:2006
Medical electrical equipment – Part 1: 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 disturbances – Requirements and tests
EN 61010-1:2010
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1:
General requirements
EN 61326-1:2013
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1:
General requirements
EN IEC 61000-3-2:2019
Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions
(equipment input current =16 A per phase)
EN 61000-3-3:2013
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
EN IEC 60079-0:2018
EN IEC 60079-0:2018/AC:2020
Explosive atmospheres – Part 0: Equipment – General requirements
EN 60079-7:2015
EN 60079-7:2015/A1:2018
Explosive atmospheres – Part 7: Equipment protection by increased safety "e"
EN 60079-11:2012
Explosive atmospheres – Part 11: Equipment protection by intrinsic safety "i"
EN IEC 60079-15:2019
Explosive atmospheres – Part 15: Equipment protection by type of protection "n"
EN 60079-18:2015
Explosive atmospheres – Part 18: Equipment protection by encapsulation "m"
EN ISO 3744:2010
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
EN ISO 9001:2015
Quality management systems – Requirements
EN ISO 14001:2015
Environmental 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, 13.12.2022
John B. S. Petersen
Approval Manager
Rev. 007 – 13.12.2022
English EC Declaration of Conformity
We, Gram Scientific ApS declare under sole responsibility that the following products:
Range:
BioCompact II
Model:
610
Refrigeration:
R600a, R290, R404A & R134a
Product description:
Refrigerators and freezer for laboratory and biostorage
Valid from (Year/Week):
2023/01
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
- ATEX Directive 2014/34/EU
- 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
EN 60079-0:2012
Electrical apparatus for explosive atmospheres – Part 0: General requirements
EN 60079-11:2012
Explosive atmospheres – Part 11: Equipment protection by intrinsic safety "i"
EN 60079-15:2010
Explosive atmospheres – Part 15: Equipment protection by type of protection "n"
EN 60079-25:2010
Explosive atmospheres – Part 25: Intrinsically safe systems
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 Scientific ApS
Aage Grams Vej 1
DK-6500 Vojens
Denmark
Telephone: + 45 73 20 13 00
Vojens, 13.12.2022
John B. S. Petersen
Approval Manager
BioCompact II 210, 310, 410, 210/210 & 310/210 BioCompact II 610

Gram bioline BioCompact II Specifications

General

Brand	Gram
Model	bioline BioCompact II
Category	Medical Equipment
Language	English