EN 61326-2-6:2006

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

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. The contents of the corrigendum of September 2007 have been included in this copy.

Elektrische Mess-, Steuer-, Regel- und Laborgeräte - EMV-Anforderungen - Teil 2-6: Besondere Anforderungen - Medizinische In-vitro-Diagnosegeräte (IVD)

Matériel électrique de mesure, de commande et de laboratoire - Exigences relatives à la CEM - Partie 2- 6: Exigences particulières - Matériel médical de diagnostic in vitro (IVD)

spécifie les exigences minimales pour l'immunité et à l'émission relatives à la compatibilité électromagnétique des matériels médicaux de diagnostic in vitro, en prenant en compte les particularités et aspects spécifiques de ces matériels et de leur environnement électromagnétique. Le contenu du corrigendum de septembre 2007 a été pris en considération dans cet exemplaire.

Električna oprema za merjenje, kontrolo in laboratorijsko uporabo - Zahteve za elektromagnetno združljivost (EMC) - 2-6. del: Posebne zahteve - Diagnostična medicinska oprema in vitro (IVD) (IEC 61326-2-6:2005)

General Information

• Status: Withdrawn
• Publication Date: 04-May-2006
• Withdrawal Date: 31-Jan-2009
• ICS: 25.040.40 - Industrial process measurement and control
• ICS: 33.100 - Electromagnetic compatibility (EMC)
• Technical Committee: CLC/TC 65X - Industrial-process measurement, control and automation
• Drafting Committee: IEC/SC 65A - IEC_SC_65A
• Parallel Committee: IEC/SC 65A - IEC_SC_65A
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 04-Feb-2016
• Completion Date: 04-Feb-2016
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Ref Project: SIST EN 61326-2-6:2007 - Electrical equipment for measurement, control and laboratory use - EMC requirements -- Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

Relations

• Replaces: EN 61326:1997/A3:2003 - Electrical equipment for measurement, control and laboratory use - EMC requirements
• Effective Date: 29-Jan-2023
• Replaces: EN 61326:1997 - Electrical equipment for measurement, control and laboratory use - EMC requirements
• Effective Date: 29-Jan-2023
• Replaces: EN 61326:1997/A2:2001 - Electrical equipment for measurement, control and laboratory use - EMC requirements
• Effective Date: 29-Jan-2023
• Replaces: EN 61326:1997/A1:1998 - Electrical equipment for measurement, control and laboratory use - EMC requirements
• Effective Date: 29-Jan-2023
• Replaced By: EN 61326-2-6:2013 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 61326-2-6:2007
01-januar-2007
(OHNWULþQDRSUHPD]DPHUMHQMHNRQWURORLQODERUDWRULMVNRXSRUDER=DKWHYH]D
HOHNWURPDJQHWQR]GUXåOMLYRVW(0&GHO3RVHEQH]DKWHYH'LDJQRVWLþQD
PHGLFLQVNDRSUHPDLQYLWUR,9',(&
Electrical equipment for measurement, control and laboratory use - EMC requirements -
Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
Elektrische Mess-, Steuer-, Regel- und Laborgeräte - EMV-Anforderungen - Teil 2-6:
Besondere Anforderungen - Medizinische In-vitro-Diagnosegeräte (IVD)
Matériel électrique de mesure, de commande et de laboratoire - Exigences relatives à la
CEM - Partie 2- 6: Exigences particulières - Matériel médical de diagnostic in vitro (IVD)
Ta slovenski standard je istoveten z: EN 61326-2-6:2006
ICS:
11.100.10
25.040.40
33.100.01
SIST EN 61326-2-6:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD
EN 61326-2-6

NORME EUROPÉENNE
May 2006
EUROPÄISCHE NORM

ICS 25.040.40; 33.100 Supersedes EN 61326:1997 + A1:1998 + A2:2001 + A3:2003


English version


Electrical equipment for measurement, control and laboratory use –
EMC requirements
Part 2-6: Particular requirements –
In vitro diagnostic (IVD) medical equipment
(IEC 61326-2-6:2005)


Matériel électrique de mesure,  Elektrische Mess-, Steuer-, Regel-
de commande et de laboratoire – und Laborgeräte –
Exigences relatives à la CEM EMV-Anforderungen
Partie 2- 6: Exigences particulières – Teil 2-6: Besondere Anforderungen –
Matériel médical de diagnostic Medizinische In-vitro-Diagnosegeräte
in vitro (IVD) (IVD)
(CEI 61326-2-6:2005) (IEC 61326-2-6:2005)




This European Standard was approved by CENELEC on 2005-12-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61326-2-6:2006 E

---------------------- Page: 2 ----------------------

EN 61326-2-6:2006 - 2 -
Foreword
The text of document 65A/455/FDIS, future edition 1 of IEC 61326-2-6, prepared by SC 65A, System
aspects, of IEC TC 65, Industrial-process measurement and control, was submitted to the IEC-CENELEC
parallel vote and was approved by CENELEC as EN 61326-2-6 on 2005-12-01.
The EN 61326 series supersedes EN 61326:1997 + corrigendum September 1998 + A1:1998 + A2:2001
+ A3:2003.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2006-12-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2009-02-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 98/79/EC. See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
.
__________
Endorsement notice
The text of the International Standard IEC 61326-2-6:2005 was approved by CENELEC as a European
Standard without any modification.
__________

---------------------- Page: 3 ----------------------

- 3 - EN 61326-2-6:2006
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE Whe
...