EN IEC 60601-2-16:2019
(Main)Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
NEW!IEC 60601-2-16:2018 is available as IEC 60601-2-16:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-16:2018 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2018 does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2018 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2018 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fifth edition cancels and replaces the fourth edition of IEC 60601-2-16, published in 2012. This edition includes the following significant technical changes with respect to the previous edition: a) update of 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, of references to IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to IEC 60601-1-11:2015; b) widening of the scope; c) editorial improvements; d) addition of requirements for anticoagulant delivery means; e) other few small technical changes.
Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hämodialyse-, Hämodiafiltrations- und Hämofiltrationsgeräten
Appareils électromédicaux - Partie 2-16: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'hémodialyse, d’hémodiafiltration et d’hémofiltration
NEW!IEC 60601-2-16:2018 est disponible sous forme de IEC 60601-2-16:2018 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-16:2018 s'applique à la sécurité de base et aux performances essentielles des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration. L'IEC 60601-2-16:2018 ne prend pas en compte le système de contrôle du liquide de dialyse de l'appareil d'hémodialyse utilisant la régénération du liquide de dialyse et les systèmes de transmission centralisés. Toutefois, elle prend en compte les exigences de sécurité spécifiques de l'appareil d'hémodialyse concernant la sécurité électrique et la sécurité du patient. L'IEC 60601-2-16:2018 spécifie les exigences minimales de sécurité relatives aux appareils d'hémodialyse. Ces appareils sont destinés à être utilisés soit par le personnel médical, soit par le patient, soit par d'autres personnes formées, sous le contrôle d'un personnel ayant une bonne compétence médicale. La présente Norme internationale s'applique à tout appareil electromédical destiné à fournir un traitement d'hémodialyse, d'hémodiafiltration et d'hémofiltration à un patient souffrant d'insuffisance rénale. Cette cinquième édition annule et remplace la quatrième édition de l'IEC 60601-2-16 parue en 2012. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) 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, des références à l'IEC 60601-1-9:2007 et l'IEC 60601-1-9:2007/AMD1:2013, des références à l'IEC 60601-1-10:2007 et l'IEC 60601-1-10:2007/AMD1:2013 ainsi que des références à l'IEC 60601-1-11:2015; b) élargissement du domaine d'application; c) améliorations d'ordre rédactionnel; d) ajout d'exigences concernant les dispositifs de transmission d'anticoagulant; e) quelques autres modifications techniques limitées.
Medicinska električna oprema - 2-16. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za hemodializo, hemodiafiltracijo in hemofiltracijo (IEC 60601-2-16:2018)
Standard IEC 60601-2-16:2018 se uporablja za osnovno varnost in bistvene lastnosti opreme za hemodializo, hemodiafiltracijo in hemofiltracijo. Standard IEC 60601-2-16:2018 ne zajema nadzornega sistema za dializno tekočino opreme za hemodializo, ki uporablja regeneracijo dializne tekočine in osrednje sisteme dovajanja. Zajema pa specifične varnostne zahteve opreme za hemodializo v povezavi z električno varnostjo in varnostjo pacienta. Standard IEC 60601-2-16:2018 navaja minimalne varnostne zahteve opreme za hemodializo. Te naprave so namenjene uporabi s strani zdravniškega osebja oziroma pacienta ali drugega usposobljenega osebja pod nadzorom oseb s strokovnim medicinskim znanjem. Standard IEC 60601-2-16:2018 vključuje elektromedicinsko opremo za hemodializo, hemodiafiltracijo in hemofiltracijo, namenjeno pacientom z odpovedjo ledvic. Peta izdaja razveljavlja in nadomešča četrto izdajo standarda IEC 60601-2-16, objavljeno leta 2012. Ta izdaja vključuje naslednje pomembne tehnične spremembe glede na prejšnjo izdajo: a) posodobitev sklicev na standarda IEC 60601-1:2005 in IEC 60601-1:2005/AMD1:2012, sklicev na standard IEC 60601-1-2:2014 in njegovih zahtev, sklicev na standarda IEC 60601-1-6:2010 in IEC 60601-1-6:2010/AMD1:2013, sklicev na standarda IEC 60601-1-8:2006 in IEC 60601-1-8:2006/AMD1:2012 ter njunih zahtev, sklicev na standarda IEC 60601-1-9:2007 in IEC 60601-1-9:2007/AMD1:2013, sklicev na standarda IEC 60601-1-10:2007 in IEC 60601-1-10:2007/AMD1:2013 ter sklicev na standard IEC 60601-1-11:2015; b) razširitev področja uporabe; c) redakcijske izboljšave; d) dodane zahteve za sredstva za dovajanje antikoagulantov; e) drugih nekaj manjših tehničnih sprememb.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 60601-2-16:2019
01-september-2019
Nadomešča:
SIST EN 60601-2-16:2015
Medicinska električna oprema - 2-16. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za hemodializo, hemodiafiltracijo in hemofiltracijo (IEC
60601-2-16:2018)
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and
essential performance of haemodialysis, haemodiafiltration and haemofiltration
equipment (IEC 60601-2-16:2018)
Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Hämodialyse-,
Hämodiafiltrations- und Hämofiltrationsgeräten (IEC 60601-2-16:2018)
Appareils électromédicaux - Partie 2-16: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils d'hémodialyse, d’hémodiafiltration et
d’hémofiltration (IEC 60601-2-16:2018)
Ta slovenski standard je istoveten z: EN IEC 60601-2-16:2019
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN IEC 60601-2-16:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 60601-2-16:2019
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SIST EN IEC 60601-2-16:2019
EUROPEAN STANDARD EN IEC 60601-2-16
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2019
ICS 11.040.20; 11.040.25 Supersedes EN 60601-2-16:2015
English Version
Medical electrical equipment - Part 2-16: Particular requirements
for the basic safety and essential performance of haemodialysis,
haemodiafiltration and haemofiltration equipment
(IEC 60601-2-16:2018)
Appareils électromédicaux - Partie 2-16: Exigences Medizinische elektrische Geräte - Teil 2-16: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils d'hémodialyse, wesentlichen Leistungsmerkmale von Hämodialyse-,
d'hémodiafiltration et d'hémofiltration Hämodiafiltrations- und Hämofiltrationsgeräten
(IEC 60601-2-16:2018) (IEC 60601-2-16:2018)
This European Standard was approved by CENELEC on 2018-05-25. 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 60601-2-16:2019 E
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SIST EN IEC 60601-2-16:2019
EN IEC 60601-2-16:2019 (E)
European foreword
The text of document 62D/1557/FDIS, future edition 5 of IEC 60601-2-16, 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 60601-2-16:2019.
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 60601-2-16:2015.
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 60601-2-16:2018 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes ha
...
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