Customer Support: +353 (0)1 857 6730

Corporate Website About Us
  • Shopping Cart
    There are no items in your cart
Please enter a keyword to search
Advanced search
Home
CENELEC
EN 61326-2-6:2013

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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

Superseded date

12-06-2021

Superseded by

EN IEC 61326-2-6:2021

Published date

03-05-2013

Publisher

European Committee for Standards - Electrical

Sorry this product is not available in your region.

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

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.

Committee
CLC/TC 65X
DevelopmentNote
Supersedes EN 61326. (05/2006) To be read in conjunction with EN 61326-1. (05/2013) Supersedes UNE EN 61326-2-6. (02/2016)
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy
Supersedes

I.S. EN ISO 15197:2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
UNE-EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

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 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

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Get in touch with us