EN 62353:2014
(Main)Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
IEC 62353:2014 applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1:2005 (third edition) and its amendments, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such ME equipment or ME systems or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the ME equipment or ME system is designed. This standard contains "general requirements", which contain clauses of general concern, and "particular requirements", further clauses handling special types of ME equipment or ME systems and applying in connection with the "General requirements". This standard is not suitable to assess whether ME equipment or ME systems or any other equipment comply with the relevant standards for their design. This standard is not applicable to the assembly of ME systems. For assembling ME systems see Clause 16 of IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012. This standard does not define requirements for repair, exchange of components and modification of ME equipment or ME systems. All maintenance, inspection, servicing, and repair done in accordance with the manufacturer's instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requirements should be assessed and verified, before the tests of this standard are performed. This standard is also applicable to tests after repair. This second edition cancels and replaces the first edition of IEC 62353 published in 2007. This edition constitutes a technical revision including the following main revisions: - clarification in 5.3.4.1 that measurements of leakage currents based on test configurations derived from IEC 60601-1 are an allowable alternative method and the inclusion of informative explanation in Annex A; - revision of the protective earth resistance requirements for ME systems using multiple socket outlets to take account of IEC 60601-1:2005/AMD1:2012 on the safe allowed values of protective earth resistance of plugged-in equipment; - the inclusion of expected minimum insulation resistance values in Table 2; and - a reordering of the sequence of testing in Annex B.
Medizinische elektrische Geräte - Wiederholungsprüfungen und Prüfung nach Instandsetzung von medizinischen elektrischen Geräten
Appareils électromédicaux - Essai récurrent et essai après réparation d’un appareil électromédical
L'IEC 62353:2014 s'applique aux essais des appareils électromédicaux et des systèmes électromédicaux, ci-après dénommés appareils EM et systèmes EM, ou des parties de ces appareils ou systèmes, conformes à l'IEC 60601-1:1988 (deuxième édition) et à ses amendements et à l'IEC 60601-1:2005 (troisième édition) et à ses amendements, avant leur mise en service, pendant la maintenance, l'inspection, l'entretien courant et après leur réparation ou à l'occasion d'essais récurrents afin d'évaluer la sécurité de ces appareils EM ou systèmes EM ou de leurs parties. Pour les appareils non construits conformément à l'IEC 60601-1, ces exigences peuvent être utilisées en tenant compte des normes de sécurité pour la conception et les informations contenues dans les instructions d'utilisation de ces appareils. La présente norme comprend des tableaux donnant des valeurs admissibles se rapportant aux différentes éditions de l'IEC 60601-1. Pour les besoins de la présente norme, l'application des méthodes de mesure est indépendante de l'édition selon laquelle les appareils EM ou les systèmes EM sont conçus. La présente norme comprend des "exigences générales", contenant des articles de portée générale, et des "exigences particulières", d'autres articles traitant de types spéciaux d'appareils EM ou de systèmes EM et s'appliquant en conjonction avec les "exigences générales". La présente norme n'est pas appropriée pour évaluer si des appareils EM ou des systèmes EM ou d'autres appareils satisfont ou non aux normes correspondantes relatives à leur conception. La présente norme ne s'applique pas à l'assemblage des systèmes EM. Pour l'assemblage des systèmes EM, voir l'Article 16 de l'IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012. La présente norme ne définit pas d'exigence pour la réparation, l'échange des composants et la modification des appareils EM ou des systèmes EM. Toutes les opérations de maintenance, inspection, entretien courant et réparation effectuées conformément aux instructions du fabricant conservent la conformité à la norme utilisée pour la conception de l'appareil. Sinon, il convient d'évaluer et de vérifier la conformité aux exigences applicables avant d'effectuer les essais de la présente norme. La présente norme s'applique également aux essais après réparation. Cette deuxième édition annule et remplace la première édition de l'IEC 62353 parue en 2007. Cette édition constitue une révision technique qui contient les principales modifications suivantes: - clarification en 5.3.4.1 que les mesurages des courants de fuite sur la base des configurations d'essai dérivées de l'IEC 60601-1 représentent une autre méthode acceptable, et ajout d'explications informatives en Annexe A; - révision des exigences relatives à la résistance de terre de protection pour les systèmes EM utilisant des socles de prises multiples, de façon à prendre en compte l'IEC 60601-1 Amendement 1 concernant les valeurs admises sûres de la résistance de terre de protection des appareils branchés; - ajout des valeurs minimales attendues de la résistance d'isolement dans le Tableau 2; - et nouvel ordre pour la séquence des essais en Annexe B. La version française de cette norme n'a pas été soumise au vote.
Medicinska električna oprema - Ponavljalni preskus in preskus po popravilu medicinske električne opreme (IEC 62353:2014)
Ta mednarodni standard se uporablja za preskušanje MEDICINSKE ELEKTRIČNE OPREME in MEDICINSKIH ELEKTRIČNIH SISTEMOV, v nadaljnjem besedilu: ME OPREMA in ME SISTEMI, ali delov take opreme ali sistemov, ki so v skladu s standardom IEC 60601-1:1988 (druga izdaja) in njegovimi spremembami ter standardom IEC 60601-1:2005 (tretja izdaja) in njegovimi spremembami, pred ZAČETKOM UPORABE, med VZDRŽEVANJEM, INŠPEKCIJSKIMI PREGLEDI, SERVISIRANJEM in po POPRAVILU ali med PONAVLJALNIMI PRESKUSI za oceno varnosti take ME OPREME ali ME SISTEMOV ali njihovih delov. Za opremo, ki ni izdelana v skladu s standardom IEC 60601-1, se lahko te zahteve uporabljajo ob upoštevanju varnostnih standardov za zasnovo in informacije v navodilih za uporabo te opreme.
Ta standard vsebuje preglednice z dovoljenimi vrednostmi v zvezi z različnimi izdajami standarda IEC 60601-1. Za namen tega standarda je uporaba merilnih metod neodvisna od izdaje, v skladu s katero je ME OPREMA ali ME SISTEM zasnovan.
Ta standard vključuje:
– »splošne zahteve«, ki zajemajo splošna določila, in
– »posebne zahteve«, dodatna določila, ki obravnavajo posebne vrste ME OPREME ali ME SISTEMOV in se uporabljajo v zvezi s splošnimi zahtevami.
OPOMBA: Na tej stopnji ni posebnih zahtev.
Ta standard ni primeren za oceno, ali je ME OPREMA ali ME SISTEMI ali katera koli druga oprema skladna z ustreznimi standardi za njihovo zasnovo.
Ta standard se ne uporablja za sestav ME SISTEMOV. V zvezi s sestavljanjem ME SISTEMOV si oglejte točko 16 standarda IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:20121.
Ta standard ne določa zahtev za POPRAVILO, izmenjavo komponent in SPREMINJANJE ME OPREME ali ME SISTEMOV.
Vse dejavnosti VZDRŽEVANJA, INŠPEKCIJSKIH PREGLEDOV, SERVISIRANJA in POPRAVIL, izvedene v skladu z navodili PROIZVAJALCA, ohranjajo skladnost s standardom, ki se uporablja za zasnovo opreme. Sicer bi bilo treba oceniti in preveriti skladnost z ustreznimi zahtevami pred izvedbo preskusov iz tega standarda.
Ta standard se uporablja tudi za preskuse po POPRAVILU.
V standardu IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012 se zahteva, da PROIZVAJALEC v okviru POSTOPKA ZA OBVLADOVANJE TVEGANJA premisli o tem, kako je mogoče zagotoviti varnost ME OPREME ali ME SISTEMA med življenjsko dobo izdelka. Kot del postopka za obvladovanje tveganja lahko PROIZVAJALEC opredeli postopke VZDRŽEVANJA. To vključuje določitev ustreznih preskusov za ME OPREMO ali ME SISTEM. PROIZVAJALEC lahko določi ustrezne merilne nastavitve in metode,
vključno s preskusi za zagotavljanje učinkovitosti v navodilih za uporabo ali drugih SPREMNIH DOKUMENTIH. Ta standard zagotavlja skladne preskusne postopke.
Ta standard ni namenjen določitvi časovnih intervalov za PONAVLJALNE POSKUSE. Če takih intervalov ne določi PROIZVAJALEC, se lahko dodatek F uporabi za pomoč pri opredelitvi takih intervalov. Preskušanje električne inštalacije na medicinskih lokacijah, vključno z NAPAJALNIM OMREŽJEM in povezanim ožičenjem, je izključeno iz tega standarda. Take preskuse obravnava standard IEC 60364-7-710 ali nacionalni ekvivalenti.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2014
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SIST EN 62353:2008
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Medical electrical equipment - Recurrent test and test after repair of medical electrical
equipment
Medizinische elektrische Geräte - Wiederholungsprüfungen und Prüfung nach
Instandsetzung von medizinischen elektrischen Geräten
Appareils électromédicaux – Essai récurrent et essai après réparation d’un appareil
électromédical
Ta slovenski standard je istoveten z: EN 62353:2014
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN 62353
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040 Supersedes EN 62353:2008
English Version
Medical electrical equipment - Recurrent test and test after repair
of medical electrical equipment
(IEC 62353:2014)
Appareils électromédicaux - Essai récurrent et essai après Medizinische elektrische Geräte - Wiederholungsprüfungen
réparation d'un appareil électromédical und Prüfung nach Instandsetzung von medizinischen
(CEI 62353:2014) elektrischen Geräten
(IEC 62353:2014)
This European Standard was approved by CENELEC on 2014-10-09. 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, 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
© 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 62353:2014 E
Foreword
The text of document 62A/942/FDIS, future edition 2 of IEC 62353 prepared by SC 62A "Common
aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in
medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be (dop) 2015-07-09
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2017-10-09
• latest date by which the national
standards conflicting with the
document have to be withdrawn
This document supersedes EN 62353:2008.
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.
Endorsement notice
The text of the International Standard IEC 62353:2014 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60335 Series NOTE Harmonized as EN 60335 Series.
IEC 60950 Series NOTE Harmonized as EN 60950 Series.
IEC 60950-1 NOTE Harmonized as EN 60950-1.
IEC 61010 Series NOTE Harmonized as EN 61010 Series.
IEC 61557-2:2007 NOTE Harmonized as EN 61557-2:2007 (not modified).
IEC 61557-4:2007 NOTE Harmonized as EN 61557-4:2007 (not modified).
1) 1)
IEC 61557-16 NOTE Harmonized as EN 61557-16 (not modified).
IEC 62020 NOTE Harmonized as EN 62020.
ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2012 (not modified).
ISO 14971:2007 NOTE Harmonized as EN ISO 14971:2012 (not modified).
IEC 60364-7-710 NOTE Harmonized as HD 60364-7-710.
IEC 61010-2-010 NOTE Harmonized as EN 61010-2-010.
1)
To be published.
- 3 - EN 62353:2014
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu
Publication Year Title EN/HD Year
IEC 60417-DB - Graphical symbols for use on equipment - -
IEC 60601-1 1988 Medical electrical equipment - EN 60601-1 1990
Part 1: General requirements for safety + corr. July 1994
+ A1 1991 + A1 1993
+ A1/corr. July 1994
+ A2 1995 + A2 1995
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic + corr. March 2010
safety and essential performance + corr. May 2014
+A1 2012 + A1 2013
+ A1/corr. July 2014
IEC 61010-1 - Safety requirements for electrical EN 61010-1 -
equipment for measurement, control and
laboratory use -
Part 1: General requirements
IEC 61010-031 - Safety requirements for electrical EN 61010-031 -
equipment for measurement, control
and laboratory use -
Part 031: Safety requirements for hand-
held probe assemblies for electrical
measurement and test
IEC 61140 - Protection against electric shock - EN 61140 -
Common aspects for installation and
equipment
IEC 61557-1 - Electrical safety in low voltage distribution EN 61557-1 -
systems up to 1 000 V a.c. and 1 500 V
d.c. - Equipment for testing, measuring or
monitoring of protective measures -
Part 1: General requirements
IEC 62353 ®
Edition 2.0 2014-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment – Recurrent test and test after repair of medical
electrical equipment
Appareils électromédicaux – Essai récurrent et essai après réparation d’un
appareil électromédical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XB
ICS 11.040 ISBN 978-2-8322-1847-1
– 2 – IEC 62353:2014 © IEC 2014
CONTENTS
FOREWORD . 5
1 Scope . 7
2 Normative references . 8
3 Terms and definitions . 8
4 Requirements . 16
4.1 * General requirements . 16
4.2 Testing before PUTTING INTO SERVICE, after MODIFICATIONS, and after REPAIR . 17
4.3 * RECURRENT TEST . 18
5 * Tests . 18
5.1 General . 18
5.2 Visual INSPECTION . 18
5.3 Measurements . 19
5.3.1 General . 19
5.3.2 Measuring of PROTECTIVE EARTH RESISTANCE . 19
5.3.3 * Measurement of insulation resistance (not mandatory) . 21
5.3.4 Leakage currents . 24
5.4 Functional test . 31
6 Results of test and evaluation . 31
6.1 Reporting of results. 31
6.2 Evaluation . 32
Annex A (informative) General guidance and rationale . 33
A.1 Intended audience . 33
A.2 Differences between IEC 60601-1 and IEC 62353 . 34
A.3 Rationale . 35
Annex B (informative) Sequence of testing . 42
Annex C (normative) Requirements for the measurement equipment and for
measurement circuits for PROTECTIVE EARTH RESISTANCE and leakage currents . 44
C.1 Requirements for the measurement equipment . 44
C.2 Measurement equipment for measurement of PROTECTIVE EARTH RESISTANCE . 44
C.3 Measurement equipment for measurements of EQUIPMENT LEAKAGE CURRENT . 45
C.4 Measurement equipment for measurements of APPLIED PART LEAKAGE
CURRENT . 45
Annex D (informative) PATIENT ENVIRONMENT . 47
Annex E (normative) Allowable values for leakage currents from IEC 60601-1 . 48
Annex F (informative) Testing intervals . 51
Annex G (informative) Example of test documentation . 52
Annex H (informative) Notes on testing ME SYSTEMS . 53
H.1 Overview . 53
H.2 Guidelines for re-testing of an ME SYSTEM . 53
H.3 Guidelines on ME SYSTEMS from the rationale annex of IEC 60601-
1:2005 /AMD1:2012 . 54
H.4 Examples of application of MULTIPLE SOCKET-OUTLETS (MSO) . 58
Bibliography . 60
Index of defined terms . 61
IEC 62353:2014 © IEC 2014 – 3 –
Figure 1 – Measuring circuit for the measurement of PROTECTIVE EARTH RESISTANCE in
ME EQUIPMENT that is disconnected from the SUPPLY MAINS . 20
Figure 2 – Measuring circuit for the measurement of PROTECTIVE EARTH RESISTANCE in
ME EQUIPMENT or ME SYSTEMS, which for functional reasons cannot be disconnected
from the SUPPLY MAINS, or in ME EQUIPMENT or ME SYSTEMS permanently connected to
the SUPPLY MAINS . 20
Figure 3 – Measuring circuit for the measurement of the insulation resistance between
MAINS PART and protective earth for CLASS I ME EQUIPMENT and between MAINS PART and
(non-earthed) ACCESSIBLE CONDUCTIVE PARTS for CLASS I and CLASS II ME EQUIPMENT . 22
Figure 4 – Measuring circuit for measurement of the insulation resistance between
MAINS PART and APPLIED PARTS which make a patient connection for CLASS I or CLASS II
ME EQUIPMENT . 23
Figure 5 – Measuring circuit for measurement of the insulation resistance between F-
TYPE APPLIED PARTS which make a patient connection and protective earth for CLASS I
ME EQUIPMENT and between F-TYPE APPLIED PARTS which make a patient connection and
(non-earthed) ACCESSIBLE CONDUCTIVE PARTS for CLASS I and CLASS II ME EQUIPMENT . 23
Figure 6 – Measuring cir
...
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