Conformance To Standards - Agilent Technologies BioTek Epoch 2 Instructions For Use Manual

Absorbance microplate spectrophotometer
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Preface

Conformance to Standards

The Epoch 2 meets the requirements of the following standards:
2014/35/EU – Low Voltage Directive
2014/30/EU – EMC Directive
2017/746 – In Vitro Diagnostic Regulation
2011/65/EU (with exemptions) and (EU) 2015/863 – RoHS Directives
2012/19/EU – WEEE Directive as amended by (EU) 2018/849
2006/42/EC of the European Parliament and of the Council of 17 May 2006 on
machinery
Standard
IEC QC 080000
UL 61010-1
EN 61010-1
EN 61010-2-010
EN 61010-2-101
CAN/CSA C22.2 No. 61010-1
CAN/CSA C22.2 No. 61010-2-010
CAN/CSA C22.2 No. 61010-2-101
Agilent BioTek Epoch 2 Instructions for Use
1771011I Revision C
Description
IEC Quality Assessment System for Electronic
Components (IECQ System) - Hazardous Substance
Process Management (HSPM) System Requirements
UL Standard for Safety Electrical Equipment For
Measurement, Control, and Laboratory Use; Part 1:
General Requirements
Safety Requirements for Electrical Equipment For
Measurement, Control, and Laboratory Use – Part 1:
General Requirements
Safety Requirements for Electrical Equipment For
Measurement, Control, and Laboratory Use – Part 2-010:
Particular requirements for laboratory equipment for the
heating of materials
Safety Requirements for Electrical Equipment For
Measurement, Control, and Laboratory Use – Part 2-101:
Particular requirements for in vitro diagnostic (IVD)
medical equipment
Safety Requirements for Electrical Equipment For
Measurement, Control, and Laboratory Use – Part 1:
General Requirements
Safety Requirements for Electrical Equipment For
Measurement, Control, and Laboratory Use – Part 2-010:
Particular requirements for laboratory equipment for the
heating of materials
Safety Requirements for Electrical Equipment For
Measurement, Control, and Laboratory Use – Part 2-101:
Particular requirements for in vitro diagnostic (IVD)
medical equipment
Page 12 of 51
Agilent Technologies, Inc.

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