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CEI EN 61326-2-6 : 2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
Available format(s)

Hardcopy , PDF

Superseded date

11-04-2022

Language(s)

English - Italian

Published date

01-01-2014

1 Scope
2 Normative references
3 Terms and definitions
4 General
5 EMC test plan
6 Immunity requirements
7 Emission requirements
8 Test results and test report
9 Instructions for use
Annex A (normative) - Immunity test requirements
                      for portable test and measurement
                      equipment powered by battery or
                      from the circuit being measured
Bibliography
Annex ZA (normative) - Normative references to
                       international publications with their
                       corresponding European publications
Annex ZZ (informative) - Coverage of Essential
                         Requirements of EC Directives

Describes 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.

Committee
CT 65
DevelopmentNote
Classificazione CEI 65-102. To be used in conjunction with CEI EN 61326-1. (02/2007) Supersedes CEI EN 61326. (05/2008)
DocumentType
Standard
Pages
28
PublisherName
Comitato Elettrotecnico Italiano
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN 61326-2-6:2013 Identical
IEC 61326-2-6:2012 Identical

ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
IEEE/ANSI C63.18-2014 REDLINE American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
AAMI TIR18:2010 GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 14971:2007 Medical devices Application of risk management to medical devices

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$82.37
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