Sartorius BioPAT Trace - Page 135

BioPAT
®
Trace | Multi Trace Operating Instructions 135
Conformity Documents
Original
UK Declaration of Conformity
_____________________________________________________________________________________________
Doc: 2289110-00 SSS22UKCA014-00.en 1 / 1 PCF: 2035210 GP-124F-00_2021-12-20
Manufacturer Sartorius Stedim Systems GmbH
Robert-Bosch-Str. 5-7
34302 Guxhagen, Germany
declares under sole responsibility that the equipment
Device type Analyzer for monitoring | for parallel monitoring of bioprocesses
Type series BioPAT
®
Trace | BioPAT
®
Multi Trace
Model BPT0001 | BPT00M
in the form as delivered fulfils all the relevant provisions of the following British Regulations
and meets the applicable requirements of the British Designated Standards including any
amendments valid at the time this declaration was signed listed below:
EMC
RoHS
Regulation
The Electromagnetic
Compatibility Regulations
2016
UK Statutory Instruments
2016 No. 1091
The Restriction of the Use of
Certain Hazardous Substances in
Electrical and Electronic
Equipment Regulations 2012
UK Statutory Instruments 2012
No. 3032
Standard(s)
BS EN 61326-1:2013
BS EN IEC 63000:2018
The person authorised to compile the technical file:
Sartorius Stedim UK Ltd.
Longmead Business Centre, Blenheim Road
KT19 9 QQ Epsom, Surrey, UK
Sartorius Stedim Systems GmbH
Guxhagen, 2022-10-04
i.A. i.A.
___________________________________ __________________________________
Andreas Ceelen Zafir Asghar
Head of QA/QC – BPS Systems Manager - Product Compliance BPS Systems
Operations – BPS Systems Operations – BPS Systems
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