EN 60601-2-39:2008
(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
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 second edition cancels and replaces the first edition of IEC 60601-2-39. It constitutes a technical revision. Major changes since the last edition include a summary of additional essential performance requirements.
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
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 seconde édition annule et remplace la première édition de la CEI 60601-2-39 dont elle constitue une révision technique. Les changements principaux depuis la dernière édition incluent un résumé des exigences de performances essentielles.
Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za trebušno dializo (IEC 60601-2-39:2007)
Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ME OPREME ZA TREBUŠNO DIALIZO, kot je določeno v 201.3.208, v nadaljevanju PD OPREMA. Velja za PD OPREMO, ki jo uporablja medicinsko osebje ali je pod nadzorom medicinskih strokovnjakov, vključno s PD OPREMO, ki jo upravlja BOLNIK, ne glede na to, ali je PD OPREMA uporabljena v bolniškem ali domačem okolju. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV v okviru uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda.
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2007)Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale
(CEI 60601-2-39:2007)Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
(IEC 60601-2-39:2007)11.040.99Druga medicinska opremaOther medical equipmentICS:SIST EN 60601-2-39:2008enTa slovenski standard je istoveten z:EN 60601-2-39:200801-julij-2008SIST EN 60601-2-39:2008SLOVENSKI
STANDARDSIST EN 60601-2-39:20021DGRPHãþD
EUROPEAN STANDARD EN 60601-2-39 NORME EUROPÉENNE
EUROPÄISCHE NORM April 2008
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
© 2008 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-39:2008 E
ICS 11.040.99 Supersedes EN 60601-2-39:1999
English version
Medical electrical equipment -
Part 2-39: Particular requirements for basic safety
and essential performance of peritoneal dialysis equipment
(IEC 60601-2-39:2007)
Appareils électromédicaux -
Partie 2-39: Exigences particulières
pour la sécurité de base
et les performances essentielles
des appareils de dialyse péritonéale (CEI 60601-2-39:2007)
Medizinische elektrische Geräte -
Teil 2-39: Besondere Festlegungen
für die Sicherheit einschließlich
der wesentlichen Leistungsmerkmale
von Peritoneal-Dialyse-Geräten (IEC 60601-2-39:2007)
This European Standard was approved by CENELEC on 2008-03-01. 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, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.
EN 60601-2-39:2008
- 2 - Foreword The text of document 62D/555/CDV, future edition 2 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 Unique Acceptance Procedure and was approved by CENELEC as
EN 60601-2-39 on 2008-03-01. This European Standard supersedes EN 60601-2-39:1999 + corrigendum December 1999. Major changes since EN 60601-2-39:1999 include a summary of additional essential performance requirements. 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) 2008-12-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow) 2011-03-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. In this standard, the following print types are used: − requirements and definitions: in roman type; − test specifications: in italic type; − informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type; − TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: IN SMALL CAPITALS. In referring to the structure of this standard, the term – “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes Subclauses 7.1, 7.2, etc.); –
“subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this standard are by number only.
In this standard, the conjunctive “o
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