EN 61326-2-6:2006
(Main)Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
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- Withdrawn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
- 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
Relations
- Effective Date
- 29-Jan-2023
- Replaces
EN 61326:1997 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Effective Date
- 29-Jan-2023
- Effective Date
- 29-Jan-2023
- Effective Date
- 29-Jan-2023
- Effective Date
- 29-Jan-2023
Frequently Asked Questions
EN 61326-2-6:2006 is a standard published by CLC. Its full title is "Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment". This standard covers: 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.
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.
EN 61326-2-6:2006 is classified under the following ICS (International Classification for Standards) categories: 25.040.40 - Industrial process measurement and control; 33.100 - Electromagnetic compatibility (EMC). The ICS classification helps identify the subject area and facilitates finding related standards.
EN 61326-2-6:2006 has the following relationships with other standards: It is inter standard links to EN 61326:1997/A3:2003, EN 61326:1997, EN 61326:1997/A2:2001, EN 61326:1997/A1:1998, EN 61326-2-6:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 61326-2-6:2006 is associated with the following European legislation: EU Directives/Regulations: 98/79/EC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2007
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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.
__________
- 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 Where an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year
IEC 60050-161 1990 International Electrotechnical Vocabulary – –
Chapter 161: Electromagnetic compatibility
IEC 61326-1 2005 Electrical equipment for measurement, EN 61326-1 2006
control and laboratory use –
EMC requirements
Part 1: General requirements
ISO 14971 2000 Medical devices – Application of risk EN ISO 14971 2000
management to medical devices
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 98/79/E.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
___________
NORME CEI
INTERNATIONALE
IEC
61326-2-6
INTERNATIONAL
Première édition
STANDARD
First edition
2005-12
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)
Electrical equipment for measurement,
control and laboratory use –
EMC requirements –
Part 2-6:
Particular requirements –
In vitro diagnostic (IVD) medical equipment
IEC 2005 Droits de reproduction réservés Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
CODE PRIX
K
PRICE CODE
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue
61326-2-6 IEC:2005 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ELECTRICAL EQUIPMENT FOR MEASUREMENT,
CONTROL AND LABORATORY USE –
EMC REQUIREMENTS –
Part 2-6: Particular requirements –
In vitro diagnostic (IVD) medical equipment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
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in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
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members of its technical committees and IEC National Committees for any personal injury, property damage or
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61326-2-6 has been prepared by subcommittee 65A: System
aspects, of IEC technical committee 65: Industrial-process measurement and control.
The IEC 61326 series cancels and replaces IEC 61326:2002 and constitutes a technical
revision.
61326-2-6 IEC:2005 – 5 –
The text of this standard is based on the following documents:
FDIS Report on voting
65A/455/FDIS 65A/459/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
It consists of the following parts, under the general title Electrical equipment for
measurement, control and laboratory use – EMC requirements:
Part 1: General requirements – (Annexes A and B of IEC 61326: 2002 are integrated in
the main body of IEC 61326-1)
Part 2-1: Sensitive test and measurement equipment for EMC unprotected applications
(Annex D of IEC 61326:2002)
Part 2-2: Portable test, measuring and monitoring equipment used in low-voltage
distribution systems (Annex E of IEC 61326:2002)
Part 2-3: Transducers with integrated or remote signal conditioning (includes Annex F of
IEC 61326:2002)
Part 2-4: Insulation monitoring devices according to IEC 61557-8 and for equipment for
insulation fault location according to IEC 61557-9
Part 2-5: Test configurations, operational
...
EN 61326-2-6:2006 표준은 vitro 진단 (IVD) 의료 장비에 대한 전자기 적합성(EMC) 요구사항을 규정하고 있습니다. 이 표준은 IVD 의료 장비의 특수성과 전자기 환경을 고려하여 필요한 면역력 및 방출에 대한 최소 요구 사항을 명확히 하고 있어, 기계 및 장비의 안전성과 신뢰성을 보장하는 데 큰 강점을 가지고 있습니다. 특히, 전자기 호환성은 검사 결과의 정확성 및 신뢰성을 유지하는 데 필수적이기 때문에, 해당 표준이 요구하는 규범은 현대의료 환경에서 더욱더 중요해지고 있습니다. 이를 통해 IVD 의료 장비가 전자파에 노출되었을 때 발생할 수 있는 다양한 간섭 현상을 최소화하고, 중요한 진단 데이터의 손실을 방지할 수 있습니다. 또한, 2007년 9월의 수정 사항이 포함된 이 표준은 더욱 최신의 정보와 요구사항을 반영하고 있어, 기술 발전과 산업 변화에 따른 응용 가능성을 넓혀줍니다. 이러한 업데이트는 기준을 채택하는 제조업체와 최종 사용자 모두에게 유익하며, 지속적인 품질 개선을 도모하는 측면에서 큰 의의를 지닙니다. 따라서 EN 61326-2-6:2006 표준은 IVD 의료 장비에 필수적이며, 그러한 장비의 성능을 유지하고 개선하는 데 필요한 핵심적인 역할을 수행합니다. EMS 요구 사항과 관련하여 이 표준의 적용은 의료 기기의 안전을 보장하고, 더욱 신뢰할 수 있는 진단 환경을 제공하는 데 매우 중요한 요소입니다.
EN 61326-2-6:2006は、体外診断（IVD）用医療機器に特有の電磁両立性（EMC）要件について、最小限の基準を定めています。この標準は、IVD医療機器が直面する特別な状況や電磁環境の特性を考慮し、影響を与える要因を包括的に把握するための重要なフレームワークを提供しています。特に、医療機器に要求される耐障害性と放出要件が、厳密に設定されている点が強調されており、製品の安全性と効率性を保証するために必要不可欠です。 この規格の強みは、その適用範囲の明確さと、IVD機器が直面する特有のリスクに対応する柔軟なアプローチにあります。感度の高い機器が多く、電磁干渉からの保護が不可欠であるため、具体的な要求事項が定められることにより、開発者は効果的な対策を講じることができます。また、2007年の訂正版が含まれていることで、最新の技術動向や市場に合わせた対応が可能になっており、関係者にとって信頼性の高い情報源となっています。 さらに、EMCの要件を適切に遵守することで、医療機器の性能が向上し、患者の安全が確保されることが実証されています。このことは、患者にとっての直接的な利益をもたらすだけでなく、製造者にとっても競争優位性を確保する上で重要な要素です。総合的に見て、EN 61326-2-6:2006は、IVD医療機器に関与する全ての関係者にとって極めて重要な規格であり、医療業界における電磁両立性の標準化に寄与しています。
The standard EN 61326-2-6:2006, titled "Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment," is a critical document that delineates the minimum requirements for electromagnetic compatibility (EMC) concerning in vitro diagnostic medical devices. This standard plays a significant role in ensuring that IVD medical equipment operates reliably within its intended electromagnetic environment while minimizing electromagnetic emissions that could interfere with other devices. One of the notable strengths of EN 61326-2-6:2006 is its comprehensive nature, addressing both immunity and emissions specific to the unique functionalities and operational environments of IVD medical equipment. By focusing on the particularities of this type of equipment, the standard ensures that manufacturers can design and produce devices that meet stringent performance criteria while adhering to safety and regulatory demands. Additionally, the inclusion of the corrigendum from September 2007 enhances the standard's clarity and applicability, reflecting the most up-to-date practices and considerations within the field of EMC for medical devices. This attention to detail not only aids manufacturers in compliance but also assures healthcare professionals of the reliability and safety of the technologies they utilize. The relevance of EN 61326-2-6:2006 cannot be overstated, especially in the context of the increasing reliance on electronic equipment in medical diagnostics. As the healthcare landscape evolves and the demand for IVD equipment rises, adherence to this standard is crucial for maintaining high levels of efficacy and safety, thus fostering trust between manufacturers, healthcare providers, and patients. Moreover, the standard's structured guidelines assist in fostering a better understanding of the necessary testing protocols and design considerations for manufacturers. By following these guidelines, IVD equipment can achieve compliance with international standards, further facilitating market access and enhancing the credibility of the products. In summary, the EN 61326-2-6:2006 standard is an essential framework that effectively addresses the EMC requirements specific to in vitro diagnostic medical equipment. Its focused approach on the particularities of this sector, coupled with the incorporation of updates, makes it a robust reference for manufacturers aiming to ensure both operational reliability and regulatory compliance.
La norme EN 61326-2-6:2006, intitulée "Équipements électriques pour mesure, contrôle et usage en laboratoire - Exigences en matière d'EMC - Partie 2-6 : Exigences particulières - Équipement médical de diagnostic in vitro (IVD)", offre un cadre essentiel pour assurer la conformité des équipements médicaux de diagnostic in vitro aux exigences en matière de compatibilité électromagnétique (EMC). L'étendue de cette norme se concentre sur les exigences minimales d'immunité et d'émissions, abordant les défis spécifiques liés aux équipements IVD dans divers environnements électromagnétiques. En intégrant les particularités de ces dispositifs, la norme garantit une évaluation rigoureuse et adaptée à leur fonctionnement, prenant en compte les interactions potentielles avec d'autres équipements électroniques. Parmi les forces notables de cette norme, on trouve sa capacité à fournir des directives claires et précises qui aident les fabricants à concevoir des équipements conformes et sûrs. De plus, l'inclusion des contenus du corrigendum de septembre 2007 renforce la pertinence de la norme en intégrant des mises à jour cruciales qui reflètent les évolutions technologiques et les recommandations industrielles. La norme EN 61326-2-6:2006 est d'une grande importance car elle non seulement protège l'intégrité de l'appareil IVD, mais elle vise également à assurer la sécurité des patients et des utilisateurs. En définissant des critères stricts pour l'immunité et les émissions, elle aide à minimiser les perturbations électromagnétiques, ce qui est crucial dans le contexte médical. En résumé, cette norme fournit un cadre robuste pour les fabricants d'équipements médicaux de diagnostic in vitro, établissant des exigences claires pour garantir la compatibilité électromagnétique dans un domaine en constante évolution.
Die Norm EN 61326-2-6:2006 befasst sich umfassend mit den elektromagnetischen Verträglichkeit (EMC)-Anforderungen für elektrische Geräte, die in der Mess-, Regel- und Laboranwendung eingesetzt werden, speziell dabei für in vitro diagnostische (IVD) medizinische Geräte. Der Geltungsbereich dieser Norm ist klar umrissen und legt die Mindestanforderungen für die Immunität gegenüber und die Emissionen von elektromagnetischen Störungen fest. Dies ist von entscheidender Bedeutung, da IVD-Geräte in einem sensiblen Umfeld eingesetzt werden, in dem Präzision und Zuverlässigkeit höchste Priorität haben. Ein wesentlicher Stärke der Norm ist die detaillierte Berücksichtigung der spezifischen Besonderheiten der in vitro Diagnostik. Sie bietet klare Leitlinien, die den Herstellern helfen, die Auswirkungen ihrer Geräte auf die elektromagnetische Umgebung zu verstehen und zu minimieren. Darüber hinaus ist die Norm zeitgemäß, da sie auch die Korrekturen und Aktualisierungen aus dem Jahr 2007 einbezieht. Dies stellt sicher, dass alle relevanten Änderungen in Bezug auf die elektromagnetische Verträglichkeit in die Norm integriert wurden. Die Relevanz der EN 61326-2-6:2006 kann nicht hoch genug eingeschätzt werden, insbesondere in einer Zeit, in der technologische Entwicklungen rasant voranschreiten. Sie bietet nicht nur Standards, die die Sicherheit und Effizienz von IVD-Geräten gewährleisten, sondern fördert auch das Vertrauen in die Integrität von Diagnosetests und deren Ergebnisse. Die Norm schafft somit einen wichtigen Rahmen für die Entwicklung und den Einsatz von IVD-Geräten, der sowohl regulatorische Anforderungen als auch die Marktfähigkeit unterstützt. Insgesamt stellt die EN 61326-2-6:2006 einen bedeutenden Meilenstein in der Standardisierung von medizinischen Geräten dar, indem sie sicherstellt, dass in vitro Diagnosetests unter Berücksichtigung der elektromagnetischen Verträglichkeit zuverlässig und sicher funktionieren.
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