EN 61010-2-101:2002

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

Applies to equipment intended for in vitro diagnostic (IVD) medical purposes. This is used for the examination of specimens, including blood and tissue samples, derived from the human body. The standard also covers self-test IVD medical equipment for use by lay persons.

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

Règles de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-101: Prescriptions particulières pour les appareils médicaux de diagnostic in vitro (DIV)

S'applique sux apparels médicaux destinés aux applications de diagnostic in vitro (DIV). Les appareils sont destinés à l'examen in vitro de spécimens, y compris les prélèvements de sang et de tissus d'origine humaine. La norme s'applique aussi aux appareils utilisés par un non-initié dans un environnement domestique.

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

General Information

• Status: Withdrawn
• Publication Date: 14-Nov-2002
• Withdrawal Date: 31-Aug-2005
• 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: IEC/TC 66 - IEC_TC_66
• Parallel Committee: IEC/TC 66 - IEC_TC_66
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 24-Feb-2020
• Completion Date: 24-Feb-2020
• 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
• Mandate: M/095 - In vitro diagnostic (prog.)
• Ref Project: SIST EN 61010-2-101:2003 - Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

Relations

• Replaced By: EN 61010-2-101:2017 - Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 61010-2-101:2003
01-marec-2003
9DUQRVWQH]DKWHYH]DHOHNWULþQRRSUHPR]DPHULWYHQDG]RURYDQMHLQODERUDWRULMVNR
XSRUDERGHO3RVHEQH]DKWHYH]DGLDJQRVWLþQRPHGLFLQVNRRSUHPRLQYLWUR
,9'
Safety requirements for electrical equipment for measurement, control, and laboratory
use -- Part 2-101: Particular 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
Règles de sécurité pour appareils électriques de mesurage, de régulation et de
laboratoire -- Partie 2-101: Prescriptions particulières pour les appareils médicaux de
diagnostic in vitro (DIV)
Ta slovenski standard je istoveten z: EN 61010-2-101:2002
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
19.080 (OHNWULþQRLQHOHNWURQVNR Electrical and electronic
SUHVNXãDQMH testing
71.040.10 Kemijski laboratoriji. Chemical laboratories.
Laboratorijska oprema Laboratory equipment
SIST EN 61010-2-101:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 61010-2-101:2003

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SIST EN 61010-2-101:2003
EUROPEAN STANDARD EN 61010-2-101
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2002

ICS 11.040.55 19.080


English version


Safety requirements for electrical equipment for measurement,
control, and laboratory use
Part 2-101: Particular requirements for in vitro diagnostic (IVD)
medical equipment
(IEC 61010-2-101:2002, modified)


Règles de sécurité pour appareils Sicherheitsbestimmungen für elektrische
électriques de mesurage, de régulation Mess-, Steuer-, Regel- und Laborgeräte
et de laboratoire Teil 2-101: Besondere Anforderungen an
Partie 2-101: Prescriptions particulières In-Vitro-Diagnostik-(IVD)-Medizingeräte
pour les appareils médicaux (IEC 61010-2-101:2002, modifiziert)
de diagnostic in vitro (DIV)
(CEI 61010-2-101:2002, modifiée)





This European Standard was approved by CENELEC on 2002-09-01. 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, Czech Republic,
Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta,
Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and 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


© 2002 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 61010-2-101:2002 E

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SIST EN 61010-2-101:2003
EN 61010-2-101:2002 - 2 -
Foreword
The text of document 66/261/FDIS, future edition 1 of IEC 61010-2-101, prepared by IEC TC 66,
Safety of measuring, control, and laboratory equipment, together with common modifications prepared
by CLC/SR 66 following deliberations in CLC/BTTF 88-1, was submitted to the Unique Acceptance
Procedure and was approved by CENELEC as EN 61010-2-101 on 2002-09-01.
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) 2003-09-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2005-09-01
This Part 2-101 is to be used in conjunction with EN 61010-1:2001, Safety requirements for electrical
equipment for measurement, control and laboratory use -- Part 1: General requirements.
Consideration may be given to future editions of, or amendments to, EN 61010-1.
This Part 2-101 supplements or modifies the corresponding clauses of EN 61010-1 so as to convert it
into the European Standard: Safety requirements for in vitro diagnostic (IVD) medical equipment.
Where a particular clause or subclause of Part 1 is not mentioned in this Part 2-101, that clause or
subclause applies as far as is reasonable. Wher
...