EN 60601-2-16:2015

Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

IEC 60601-2-16:2012 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2012 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 60601-2-16:2012 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 60601-2-16:2012 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fourth edition cancels and replaces the third edition of IEC 60601-2-16, published in 2008. This edition constitutes a technical revision. Changes since the previous edition include, among others, better adaptation of IEC 60601-1-8 and improvement of subclause 201.8.3.

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

La CEI 60601-2-16:2012 s'applique à la sécurité de base et aux performances essentielles des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration. La CEI 60601-2-16:2012 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. La CEI 60601-2-16:2012 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 quatrième édition annule et remplace la troisième édition de la CEI 60601-2-16, publiée en 2008. La présente édition constitue une révision technique. Les évolutions par rapport à l'édition précédente comprennent, entre autres, une meilleure adaptation de la CEI 60601-1-8 et amélioration du paragraphe 201.8.3.

Medicinska električna oprema - 2-16. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za kemodializo, kemodiafiltracijo in kemofiltracijo

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI OPREME ZA KEMODIALIZO, KEMODIAFILTRACIJO IN KEMOFILTRACIJO (v nadaljevanju: OPREMA ZA KEMODIALIZO).
Ta mednarodni standard ne zajema nadzornega sistema za DIALIZNO TEKOČINO OPREME ZA KEMODIALIZO, ki uporablja regeneracijo DIALIZNE TEKOČINE in OSREDNJE SISTEME DOVAJANJA. Zajema pa specifične varnostne zahteve OPREME ZA KEMODIALIZO v povezavi z električno varnostjo in varnostjo PACIENTA. Ta mednarodni standard navaja minimalne varnostne zahteve OPREME ZA KEMODIALIZO. Te naprave so namenjene uporabi zdravniškega osebja oziroma PACIENTA ali drugega usposobljenega osebja pod nadzorom oseb s strokovnim medicinskim znanjem.
Ta mednarodni standard vključuje ELEKTROMEDICINSKO OPREMO za KEMODIALIZO, KEMODIAFILTRACIJO in KEMOFILTRACIJO, namenjeno PACIENTOM z odpovedjo ledvic.
Posebne zahteve v tem mednarodnem standardu ne veljajo za:
– ZUNAJTELESNE OBTOKE;
– DIALIZATORJE;
– KONCENTRATE DIALIZNE TEKOČINE;
– opremo za pripravo vode;
– opremo za PERITONEALNO DIALIZO (glejte standard IEC 60601-2-39).
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 standarda ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje tega standarda, razen v točkah 7.2.13 in 8.4.1 standarda IEC 60601-1.

General Information

• Status: Withdrawn
• Publication Date: 11-Jun-2015
• Withdrawal Date: 13-Apr-2018
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 24-May-2022
• Completion Date: 24-May-2022
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-16:2015 - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Relations

• Replaces: EN 60601-2-16:1998 - Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
• Effective Date: 28-Jan-2023
• Replaced By: EN IEC 60601-2-16:2019 - Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
• Effective Date: 23-Aug-2016

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-16:2015
01-september-2015
1DGRPHãþD
SIST EN 60601-2-16:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]DNHPRGLDOL]RNHPRGLDILOWUDFLMRLQNHPRILOWUDFLMR
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and
essential performance of haemodialysis, haemodiafiltration and haemofiltration
equipment
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
Ta slovenski standard je istoveten z: EN 60601-2-16:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN 60601-2-16:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD EN 60601-2-16

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2015
ICS 11.040.20; 11.040.25 Supersedes EN 60601-2-16:1998
English Version
Medical electrical equipment - Part 2-16: Particular requirements
for the basic safety and essential performance of haemodialysis,
haemodiafiltration and haemofiltration equipment
(IEC 60601-2-16:2012)
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 60601-2-16:2012) (IEC 60601-2-16:2012)
This European Standard was approved by CENELEC on 2015-04-14. 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
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-2-16:2015 E

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EN 60601-2-16:2015 (E)

Foreword
The text of document 62D/972/FDIS, future edition 4 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 60601-2-16:2015.
The following dates are fixed:
• latest date by which the document has (dop) 2016-01-14
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national
standards conflicting with the
document have to be withdrawn

This document supersedes EN 60601-2-16:1998.
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 relationship with EU Directive see informative Annex ZZ, which is an integral part of this
document.

Endorsement notice
The text of the International Standard IEC 60601-2-16:2012 was approved by CENELEC as a
European Standard without any modification.
In the official versio
...

SLOVENSKI STANDARD
SIST EN 60601-2-16:2015
01-september-2015
Nadomešča:
SIST EN 60601-2-16:1998
Medicinska električna oprema - 2-16. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za kemodializo, kemodiafiltracijo in kemofiltracijo
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and
essential performance of haemodialysis, haemodiafiltration and haemofiltration
equipment
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
Ta slovenski standard je istoveten z: EN 60601-2-16:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN 60601-2-16:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-16:2015

---------------------- Page: 2 ----------------------
SIST EN 60601-2-16:2015


EUROPEAN STANDARD EN 60601-2-16

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2015
ICS 11.040.20; 11.040.25 Supersedes EN 60601-2-16:1998
English Version
Medical electrical equipment - Part 2-16: Particular requirements
for the basic safety and essential performance of haemodialysis,
haemodiafiltration and haemofiltration equipment
(IEC 60601-2-16:2012)
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 60601-2-16:2012) (IEC 60601-2-16:2012)
This European Standard was approved by CENELEC on 2015-04-14. 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
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-2-16:2015 E

---------------------- Page: 3 ----------------------
SIST EN 60601-2-16:2015
EN 60601-2-16:2015 (E)

Foreword
The text of document 62D/972/FDIS, future edition 4 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 60601-2-16:2015.
The following dates are fixed:
• latest date by which the document has (dop) 2016-01-14
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national
standards conflicting with the
document have to be withdrawn

This document supersedes EN 60601-2-16:1998.
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 relationship with EU Directive see informative Annex ZZ, which is an integral part of this
document.

Endorsement notice
The text of the Internat
...