EN IEC 61010-2-101:2022/A11:2022

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment

The scope of the Amendment is the same as EN 61010-2-101:2017. It applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.

Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2-101: Besondere Anforderungen an In-vitro-Diagnostik (IVD) Medizingeräte

Exigences de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-101: Exigences particulières pour le matériel médical de diagnostic in vitro (DIV)

Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko uporabo - 2-101. del: Posebne zahteve za diagnostično in vitro (IVD) medicinsko opremo - Dopolnilo A11

General Information

• Status: Published
• Publication Date: 10-Nov-2022
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 19.080 - Electrical and electronic testing
• Technical Committee: CLC/TC 66X - Safety of measuring, control, and laboratory equipment
• Drafting Committee: CLC/TC 66X/WG 4 - IVDD
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 11-Nov-2022
• Due Date: 09-Aug-2023
• Completion Date: 11-Nov-2022
• Directive: 2006/42/EC - Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast)
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Mandate: M/396 - Mandate to CEN and Cenelec for standardisation in the field of machinery
• Ref Project: SIST EN 61010-2-101:2023/A11:2023 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment

Relations

• Amends: EN IEC 61010-2-101:2022 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
• Effective Date: 27-Apr-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 61010-2-101:2023/A11:2023
01-januar-2023
Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko
uporabo - 2-101. del: Posebne zahteve za diagnostično in vitro (IVD) medicinsko
opremo - Dopolnilo A11
Safety requirements for electrical equipment for measurement, control, and laboratory
use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2
-101: Besondere Anforderungen an In-vitro-Diagnostik (IVD) Medizingeräte
Exigences de sécurité pour appareils électriques de mesurage, de régulation et de
laboratoire - Partie 2-101 : Exigences particulières pour le matériel médical de diagnostic
in vitro (DIV)
Ta slovenski standard je istoveten z: EN IEC 61010-2-101:2022/A11:2022
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
19.080 Električno in elektronsko Electrical and electronic
preskušanje testing
71.040.10 Kemijski laboratoriji. Chemical laboratories.
Laboratorijska oprema Laboratory equipment
SIST EN 61010-2-101:2023/A11:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 61010-2-101:2023/A11:2023

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SIST EN 61010-2-101:2023/A11:2023
EUROPEAN STANDARD EN IEC 61010-2-101:2022/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2022
ICS 11.040.55; 19.080
English Version
Safety requirements for electrical equipment for measurement,
control, and laboratory use - Part 2-101: Safety requirements for
in vitro diagnostic (IVD) medical equipment
Exigences de sécurité pour appareils électriques de Sicherheitsbestimmungen für elektrische Mess-, Steuer-,
mesurage, de régulation et de laboratoire - Partie 2-101: Regel- und Laborgeräte - Teil 2-101: Besondere
Exigences particulières pour le matériel médical de Anforderungen an In-vitro-Diagnostik (IVD) Medizingeräte
diagnostic in vitro (DIV)
This amendment A11 modifies the European Standard EN IEC 61010-2-101:2022; it was approved by CENELEC on 2022-09-26.
CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
amendment 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 CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment 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 CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61010-2-101:2022/A11:2022 E

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SIST EN 61010-2-101:2023/A11:2023
EN IEC 61010-2-101:2022/A11:2022 (E)
European foreword
This document (EN IEC 61010-2-101:2022/A11:2022) has been prepared by CLC/TC 66X "Safety of
measuring, control, and laboratory equipment".
The following dates are fixed:
• latest date by which this document has to be (dop) 2023-09-26
implemented at national level by publication of
an identical national standard or by
endorsement
• latest date by which the national standards (dow) 2025-09-26
conflicting with this document have to be
withdrawn
This document amends EN IEC 61010-2-101:2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document is read in conjunction with EN 61010-1:2010 + A1:2019 as modified by
EN IEC 61010-2-101:2022 which results in the complete text of EN IEC 61010-2-101:2022. This A11 describes
how that text is modified.
Any feedback and questions on this document should be directed to the users’ national committee. A complete
listing of these bodies can be found on the CENELEC website.
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