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I.S. EN 61326-2-6:2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 (IEC 61326-2-6:2012 (EQV))
Available format(s)

Hardcopy , PDF

Superseded date

07-12-2021

Language(s)

English

Published date

01-01-2013

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

FOREWORD
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 EU Directives

Defines 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.

DevelopmentNote
Supersedes I.S. EN 61326. (02/2011) For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
DocumentType
Standard
Pages
19
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN 61326-2-6:2013 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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