EN 61010-2-101:2017
(Main)Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61010-2-101:2015 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety function, as specified in IEC Guide 104. This standard has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This second edition cancels and replaces the first edition published in 2002. It constitutes a technical revision and includes the following significant changes from the first edition, as well as numerous other changes: - excluded IEC 61010-2-081 (general laboratory equipment) from the scope. This separates IEC 61010-2-081 and IEC 61010-2-101 equipment; - updated Biohazard and Lot symbols in Table 1 in Clause 5; - added requirement for within expiration consumables and authorized representative details in Instructions for Use to Clause 5; - added requirement for gas or liquid markings and ratings to Clause 5; - added requirement to include OPERATOR instructions to deal with consumable or sample spills, jams or breakage inside equipment, disposal of hazardous waste, personal protection, RISK reduction procedures relating to flammable liquids, burns from surfaces, and loading and unloading of sample and reagents in Instructions for Use to Clause 5; - added requirement for manufacturer to provide instructions on equipment transport, storage and removal from use to Clause 5; - added normative reference ISO 18113-5 for instructions for use of self-test IVD medical equipment in Clause 5; - added requirement for OPERATOR maintenance instructions to Clause 7; - added requirements for sample zones and loading zones to Clause 7; - excluded equipment whose size and weight make unintentional movement unlikely from drop test in Clause 8; - added requirement for biohazard marking to Clause 13; - added requirement for interlock systems containing electric/electronic or programmable components to Clause 15; - added informative reference to Usability standard IEC 62366 to Clause 16; - replaced Clause 17 with requirements of ISO 14971 for RISK assessment. - Annex BB Instructions for use for self-testing IVD Medical Equipment deleted and a reference given to ISO 18113-5 in Clause 5.
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: Exigences particulières pour les appareils médicaux de diagnostic in vitro (DIV)
L'IEC 61010-2-101:2015 s'applique aux appareils destinés aux applications médicales de diagnostic in vitro (DIV), y compris aux appareils médicaux d'autodiagnostic DIV. Cette norme a le statut de publication groupée de sécurité, conformément au Guide 104 de l'IEC. La préparation de cette norme a été réalisée en étroite collaboration avec le groupe de travail CENELEC BTTF 88.1. Cette deuxième édition annule et remplace la première édition parue en 2002. Cette édition constitue une révision technique et inclut les modifications techniques majeures suivantes par rapport à la première édition, ainsi que de nombreuses autres modifications: - exclusion de l'IEC 61010-2-081 (appareils d'usage général de laboratoire) du domaine d'application, ce qui distingue les appareils de l'IEC 61010-2-081 et ceux de l'IEC 61010-2-101; - mise à jour des symboles Danger biologique et Lot dans le Tableau 1 à l'Article 5; - ajout d'une exigence relative aux consommables possédant une date d'expiration et aux informations concernant le représentant autorisé dans les Instructions d'utilisation à l'Article 5; - ajout d'une exigence relative aux marquages et caractéristiques assignées des gaz et liquides à l'Article 5; - ajout d'une exigence incluant des instructions à l'OPÉRATEUR permettant de couvrir les déversements, bourrages ou bris de consommables ou de prélèvements à l'intérieur des appareils, l'élimination des déchets dangereux, la protection individuelle, les procédures de réduction de RISQUE applicables aux liquides inflammables, brûlures causées par des surfaces, ainsi que le chargement et le déchargement de prélèvements et de réactifs dans les Instructions d'utilisation à l'Article 5; - ajout d'une exigence imposant au fabricant de fournir des instructions relatives au transport, au stockage et au retrait d'utilisation des appareils à l'Article 5; - ajout de la référence normative ISO 18113-5 relative aux instructions d'utilisation des appareils médicaux d'autodiagnostic DIV à l'Article 5; - ajout d'exigences relatives aux instructions d'entretien par l'OPÉRATEUR à l'Article 7; - ajout d'exigences relatives aux zones de prélèvement et aux zones de chargement à l'Article 7; - exclusion des appareils dont la taille et le poids rendent improbable un mouvement involontaire de l'essai de chute à l'Article 8; - ajout d'une exigence relative au marquage des dangers biologiques à l'Article 13; - ajout d'une exigence relative aux systèmes de verrouillage incluant des composants électriques/électroniques ou programmables à l'Article 15; - ajout d'une référence informative à la Norme d'aptitude à l'utilisation IEC 62366 à l'Article 16; - remplacement de l'Article 17 par les exigences de l'ISO 14971 concernant l'évaluation du RISQUE. - suppression des instructions d'utilisation de l'Annexe BB relatives aux appareils médicaux d'autodiagnostic DIV et ajout d'une référence à l'ISO 18113-5 à l'Article 5.
Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko uporabo - 2-101. del: Posebne zahteve za diagnostično medicinsko opremo in vitro (IVD) (IEC 61010-2-101:2015)
Ta standard se uporablja za opremo, ki je namenjena diagnostični medicinski uporabi in vitro (IVD), vključno z medicinsko opremo IVD za samopreskušanje. Medicinska oprema IVD, ki jo je proizvajalec predvidel za uporabo, samostojno ali v kombinaciji, in vitro za preiskavo vzorcev, vključno z vzorci krvi in tkiv, iz človeškega telesa izključno ali zlasti z namenom pridobiti podatke, ki se nanašajo na eno ali več naslednjih stvari: – psihološko ali patološko stanje; ali – prirojeno anomalijo; – ugotavljanje varnosti in združljivosti z morebitnimi prejemniki; – spremljanje terapevtskih ukrepov. Medicinsko opremo IVD za samopreskušanje je proizvajalec predvidel za uporabo s strani nestrokovnih oseb v domačem okolju.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 61010-2-101:2017
01-julij-2017
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Safety requirements for electrical equipment for measurement, control and laboratory
use - Part 2-101: Particular requirements for laboratory equipment for in vitro diagnostic
(IVD) medical equipment (IEC 61010-2-101:2015)
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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) (IEC 61010-2-101:2015)
Ta slovenski standard je istoveten z: EN 61010-2-101:2017
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 61010-2-101:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 61010-2-101:2017
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SIST EN 61010-2-101:2017
EUROPEAN STANDARD EN 61010-2-101
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2017
ICS 11.040.55; 19.080 Supersedes EN 61010-2-101:2002
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 61010-2-101:2015)
Règles de sécurité pour appareils électriques de mesurage, Sicherheitsbestimmungen für elektrische Mess-, Steuer-,
de régulation et de laboratoire - Partie 2-101: Exigences Regel- und Laborgeräte - Teil 2-101: Besondere
particulières pour les appareils médicaux de diagnostic in Anforderungen an In-vitro-Diagnostik (IVD)-Medizingeräte
vitro (DIV) (IEC 61010-2-101:2015)
(IEC 61010-2-101:2015)
This European Standard was approved by CENELEC on 2015-02-27. 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 CEN-CENELEC
Management Centre 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 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,
Switzerland, Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 61010-2-101:2017 E
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SIST EN 61010-2-101:2017
EN 61010-2-101:2017
European foreword
The text of document 66/545/FDIS, future edition 2 of IEC 61010-2-101, prepared by IEC/TC 66
"Safety of measuring, control and laboratory equipment" was submitted to the IEC-CENELEC parallel
vote and approved by CENELEC as EN 61010-2-101:2017.
The following dates are fixed:
(dop) 2017-08-24
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2020-02-24
• latest date by which the national standards conflicting with
the document have to be withdrawn
This document supersedes EN 61010-2-101:2002.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the rela
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