2 declaration of conformity, Declaration of conformity, 845 eluent synthesizer – Metrohm 845 Eluent Synthesizer User Manual

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5 Annex

845 Eluent Synthesizer / Instructions for Use 8.845.1003

64

5.3.2

Declaration of Conformity

This is to certify the conformity to the standard specifications for electri-

cal appliances and accessories, as well as to the standard specifica-

tions for security and to system validation issued by the manufacturing

company.

Name of commodity

845 Eluent Synthesizer

CH-9101 Herisau/Switzerland
E-Mail

[email protected]

www.metrohm.com

Description

The 845 Eluent Synthesizer is a device to produce mixtures like eluents, mobile phases
or standards automatically.

This instrument has been built and has undergone final type testing according to the standards:

Electromagnetic compatibility: Emission

IEC 61326, EN 55022/CISPR 22
Electromagnetic compatibility: Immunity
IEC 61326, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6,
IEC 61000-4-11, IEC 61000-4-14
Safety specifications

IEC 61010-1, UL61010-1, CSA 22.2 No. 61010-1

It has also been certified by ElectroSuisse, a member of the International Certification Body (CB/IEC).

The instrument meets the requirements of the CE mark as contained in the EU direc-
tives 89/336/EEC and 73/23/EEC and fulfils the following specifications:

EN 61326

Electrical equipment for measurement, control and laboratory use – EMC requirements

EN 61010-1 Safety requirements for electrical equipment for measurement, control and laboratory

use

Metrohm Ltd. is holder of the SQS-certificate of the quality system ISO 9001 for quality assurance in
design/development, production, installation and servicing.

The system software, stored in Read Only Memories (ROMs) has been validated in connection with
standard operating procedures in respect to functionality and performance.
The technical specifications are documented in the instruction manual.

Herisau, October 5, 2005

D. Strohm

Ch. Buchmann

Vice President

Vice President

Head of R&D

Head of Production

Responsible for Quality Assurance

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