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Declaration of Conformity MEDIACLAVE 10
INTEGRA Biosciences AG – 7205 Zizers, Switzerland
declares on its own responsibility that the devices
Description
MEDIACLAVE 10
comply with:
EU Directives (DoW: Date of Withdrawal)
Low Voltage Equipment
Pressure Equipment
Electromagnetic Compatibility
Restriction of Hazardous Substances
Waste Electrical and Electronic Equipment 2012/19/EU
EU Regulation
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 1907/2006
Directive 97/23 EC and 2014/68/EU
Description of pressure vessel
Operational fluid
Fluid group
Category (97/23 EC)
Category (2014/68/EU)
Max operating pressure
Safety valve set pressure,
Max allowable pressure PS
Description of assembly
Conformity assessment procedure Module: A1 (97/23/EC) / A2 (2014/68/EU)
Certificate No.
Notified body for inspection
Certified Q-System ISO 9001:2000
Standards for EU
Safety requirements for electrical equipment for laboratory use
Electrical equipment for laboratory use - EMC requirements
Pressure cookers
Qualification test of welders - Fusion welding - Part 1: Steels
Specification and qualification of welding procedures
Metallic products types of inspection documents, Type 3.1 certificate
Safety devices for protection against excessive pressure
Standards for Canada and USA:
Safety requirements for electrical equipment for measurement, control
and laboratory use
Requirements for laboratory equipment for the heating of materials
Pressure cookers
Operation is subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any interfer-
ence received, including interference that may cause undesired operation.
Zizers, December 3, 2018
Models
136 000, 136 005, 136 010, 136 015, 136 020, 136 025
Before DoW
2006/95/EC
97/23/EC
2004/108/EC
2011/65/EU
Allowable temperature TS
liquids/gases
Volume
2
Test pressure
I (Art. 9)
Pressure test medium
II (Art. 13)
Serial No.
1.4 bar
Marking
Safety equipment
1.7 bar
Drawing No./Rev
pressure vessel, circulation pump, safety valve,
circulation heater, heat exchanger, piping
PED-Z-COS.EP.5507079
Swiss Safety Center AG, CH-8304 Wallisellen,
CE1253
SQS, CH-3052 Zollikofen, Reg. No. 15072
Elmar Morscher
CEO
DoW
After DoW
20.04.2016
2014/35/EU
19.07.2016
2014/68/EU
20.04.2016
2014/30/EU
0-126 °C
V
16.3 l
PT
2.5 bar
water
0267-7999
CE1253
assembly
136400/09
EN 61010-1: 2010
EN 61326-1: 2013
EN 12778: 2002
EN 9606-1: 2013
EN 15614-1: 2004
EN 10204: 2004
EN 4126-1: 2013
UL 61010-1
UL 61010-2-10
UL 136
Part 15 of the
FCC Rules
Class A
Thomas Neher
Quality Manager
Publicité
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