EN IEC 60601-2-39:2019
(Main)Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
NEW!IEC 60601-2-39:2018 is available as IEC 60601-2-39:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-39:2018 applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This third edition cancels and replaces the second edition of IEC 60601-2-39. It constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition: - update of the references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012 and of references and requirements to IEC 60601-1-11:2015; - editorial improvements; - improvement of the essential performance requirements clause/subclauses; - new requirements for the interruption of the power supply.
Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale
NEW!IEC 60601-2-39:2018 est disponible sous forme de IEC 60601-2-39:2018 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-39:2018 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux de dialyse péritonéale. Elle s'applique aux appareils de dialyse péritonéale destinés à être utilisés soit par le personnel médical soit sous la supervision d'experts médicaux, y compris les appareils de dialyse péritonéalemis en fonctionnement par le patient, que l'appareil de dialyse péritonéale soit utilisé dans un hôpital ou dans un environnement domestique. Cette troisième édition annule et remplace la seconde édition de l'IEC 60601-2-39 dont elle constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: - actualisation des références à l'IEC 60601-1:2005 et l'IEC 60601-1:2005/AMD1:2012, des références et des exigences à l'IEC 60601-1-2:2014, des références à l'IEC 60601-1-6:2010 et l'IEC 60601-1-6:2010/AMD1:2013, des références et des exigences à l'IEC 60601-1-8:2006 et l'IEC 60601-1-8:2006/AMD1:2012, et des références et des exigences à l'IEC 60601-1-11:2015; - améliorations d'ordre rédactionnel; - amélioration des articles/paragraphes traitant des exigences relatives aux performances essentielles; - nouvelles exigences concernant la coupure de l'alimentation.
Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za trebušno dializo (IEC 60601-2-39:2018)
Ta del standard IEC 60601 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI OPREME ZA TREBUŠNO DIALIZO (v nadaljevanju »OPREMA ZA TREBUŠNO DIALIZO«), kot je določeno v točki 201.3.208. Uporablja se za OPREMO ZA TREBUŠNO DIALIZO, ki jo uporablja zdravniško osebje ali se uporablja pod nadzorom oseb s strokovnim medicinskim znanjem, vključno z OPREMO ZA TREBUŠNO DIALIZO, ki jo upravlja PACIENT, ne glede na to, ali se OPREMA ZA TREBUŠNO DIALIZO uporablja v bolnišnici ali doma.
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.
Posebne zahteve tega dokumenta ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje uporabe tega dokumenta, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda.
Ta dokument se lahko uporablja tudi za OPREMO ZA TREBUŠNO DIALIZO, ki se uporablja za lajšanje bolezni, poškodb ali invalidnosti.
Te posebne zahteve se ne uporabljajo za DIALIZNO RAZTOPINO ali OBTOK DIALIZNE RAZTOPINE.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2019
Nadomešča:
SIST EN 60601-2-39:2008
SIST EN 60601-2-39:2008/A11:2012
Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za trebušno dializo (IEC 60601-2-39:2018)
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and
essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2018)
Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten (IEC
60601-2-39:2018)
Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de dialyse péritonéale (IEC 60601-2-
39:2018)
Ta slovenski standard je istoveten z: EN IEC 60601-2-39:2019
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60601-2-39
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2019
ICS 11.040.99 Supersedes EN 60601-2-39:2008
English Version
Medical electrical equipment - Part 2-39: Particular requirements
for basic safety and essential performance of peritoneal dialysis
equipment
(IEC 60601-2-39:2018)
Appareils électromédicaux - Partie 2-39: Exigences Medizinische elektrische Geräte - Teil 2-39: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de dialyse péritonéale wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-
(IEC 60601-2-39:2018) Geräten
(IEC 60601-2-39:2018)
This European Standard was approved by CENELEC on 2018-05-11. 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: Rue de la Science 23, B-1040 Brussels
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-39:2019 E
European foreword
The text of document 62D/1558/FDIS, future edition 3 of IEC 60601-2-39, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-39:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2019-11-24
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-05-24
document have to be withdrawn
This document supersedes EN 60601-2-39:2008.
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.
Endorsement notice
The text of the International Standard IEC 60601-2-39:2018 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 60601-1-6:2010 NOTE Harmonized as EN 60601-1-6:2010 (not modified)
IEC 60601-1-9:2007 NOTE Harmonized as EN 60601-1-9:2008 (not modified)
IEC 60601-1-10:2007 NOTE Harmonized as EN 60601-1-10:2008 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1 Where 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.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
+ A1 2013 + A1 2015
IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: EN 60601-1-8 2007
General requirements for basic safety and
essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A11 2017
Addition
IEC 60601-1-11 2015 Medical electrical equipment - Part 1-11: EN 60601-1-11 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for medical
electrical equipment and medical electrical
systems used in the home healthcare
environment
IEC 60601-2-39 ®
Edition 3.0 2018-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-39: Particular requirements for basic safety and essential performance of
peritoneal dialysis equipment
Appareils électromédicaux –
Partie 2-39: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de dialyse péritonéale
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.99 ISBN 978-2-8322-5552-0
– 2 – IEC 60601-2-39:2018 © IEC 2018
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT identification, marking and documents . 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 19
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 19
201.15 Construction of ME EQUIPMENT . 19
201.16 ME SYSTEMS . 19
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 20
202 Electromagnetic disturbances – Requirements and tests . 20
208 * General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 20
209 Requirements for environmentally conscious design . 21
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 22
Annexes . 23
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 24
Annex AA (informative) Particular guidance and rationale . 25
Bibliography . 26
Index of defined terms used in this particular standard . 27
Table 201.101 – ESSENTIAL PERFORMANCE requirements . 11
IEC 60601-2-39:2018 © IEC 2018 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-39: Particular requirements for basic safety and essential
performance of peritoneal dialysis equipment
FOREWORD
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