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MABTECH IRIS FluoroSpot Manuel D'utilisation page 4

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Les langues disponibles

Les langues disponibles

Regulatory information
The Mabtech IRIS
Directive
CE mark for the European Economic Area (EEA)
2014/30/EU – Electromagnetic
Compatibility Directive (EMC)
2014/35/EU – Low Voltage Directive
(LVD)
2011/65/EU – Restriction of Hazardous
Substances Directive (RoHS)
2006/42/EC – Machinery Directive (MD)
North America
FCC Part 2
FCC Part 15*
ICES-003
International Standards
EMC
Safety
*This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules� These limits are designed to
4
FluoroSpot/ELISpot reader complies with the following directives:
TM
Applied standards
EN 61326-1, edition 3:2013-01-11
EN 61326-2-6, edition 2:2013-05-03
EN 55011, edition 5:2016-04-01 +A1:2017-
04-21+A11:2020-03-06+A2:2021-04-09
EN 61000-3-2, edition 5:2019-03-01, edition
4:2014-08-22
EN 61000-3-3, edition 3:2013-08-
23+A1:2019-08-02
EN 61010-1, edition 3:2010-10-15+ A1:2019-
02-22
EN 61010-2-101, edition 2:2017-02-24
Safety test according to particular requirements for in
vitro diagnostic (IVD) medical equipment.
EN 62471, edition 1:2008-09-12
CENELEC EN IEC 63000, edition 1:2018-12-07
§§2�906 SDoC:2019-10-01
§15�107:2019-10-01
§15�109:2019-10-01
Issue 7:2020-10-15
IEC 61326-1, edition 2:2012-07-10
IEC 61326-2-6, edition 2:2012-07-10
CISPR 11, edition 6:2015-06-09+A1:2016-06-
23+A2:2019-01-18
IEC 61000-3-2, edition 5:2018-01-26; edition
4:2014-05-26
IEC 61000-3-3, edition 3:2013-05-
14+A1:2017-05-18
IEC 61010-1, edition 3:2010-06-10+A1:2016-
12-16
IEC 61010-2-101, edition 2:2015-01-23
IEC 62471, edition 1:2006-07-26

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Ce manuel est également adapté pour:

Iris elispot