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BS EN 61326-2-6:2013

$102.76

Electrical equipment for measurement, control and laboratory use. EMC requirements – Particular requirements. In vitro diagnostic (IVD) medical equipment

Published By Publication Date Number of Pages
BSI 2013 16
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IEC 61326-2-6:2012 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for in vitro diagnostic medical equipment, taking into account the particularities and specific aspects of this electrical equipment and their electromagnetic environment. This second edition cancels and replaces the first edition published in 2005 and constitutes a technical revision. It includes the following significant technical change: update of the document with respect to IEC 61326-1:2012. This publication is to be read in conjunction with /2.

PDF Catalog

PDF Pages PDF Title
7 English
CONTENTS
8 1 Scope
2 Normative references
3 Terms and definitions
9 4 General
4.101 Electromagnetic environment of IVD medical equipment
5 EMC test plan
5.1 General
5.2 Configuration of EUT during testing
5.3 Operation conditions of EUT during testing
5.3.101 Operational conditions
5.4 Specification of functional performance
5.5 Test description
10 6 Immunity requirements
6.1 Conditions during the tests
6.2 Immunity test requirements
11 6.3 Random aspects
Table 101 – Immunity requirements for IVD medical equipment
12 6.4 Performance criteria
7 Emission requirements
8 Test results and test report
9 Instructions for use
9.1 Requirements for the IVD medical equipment instruction for use
9.2 Instructions for IVD medical equipment for self-testing
9.3 Instructions for IVD medical equipment for professional use
13 Annex A (normative) Immunity test requirements for portable test and measurement equipment powered by battery or from the circuit being measured
14 Bibliography
BS EN 61326-2-6:2013
$102.76