EN 60601-2-16:2015
(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
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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 version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-2-16:1998 NOTE Harmonized as EN 60601-2-16:1998 (not modified).
IEC 60601-2-39 NOTE Harmonized as EN 60601-2-39.
ISO 11197 NOTE Harmonized as EN ISO 11197.
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.
Annex ZA of EN 60601-1:2006 applies with the following exceptions:
Publication Year Title EN/HD Year
Replacement :
IEC 60601-1-2 2007 Medical electrical equipment - Part 1-2: EN 60601-1-2 2007
General requirements for basic safety and
essential performance - Collateral
+ corr March 2010
standard: Electromagnetic compatibility -
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
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
+ corr March 2010
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
Addition:
IEC 60601-1-10 2007 Medical electrical equipment - Part 1-10: EN 60601-1-10 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for the
development of physiologic closed-loop
controllers
IEC 60601-1-11 2010 Medical electrical equipment - Part 1-11: EN 60601-1-11 2010
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 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices
ISO 594-2 - Conical fittings with 6 % (Luer) taper for
syringes, needles and certain other
medical equipment - Part 2: Lock fittings
ISO 3744 - Acoustics - Determination of sound power EN ISO 3744 -
levels and sound energy levels of noise
sources using sound pressure -
Engineering methods for an essentially
free field over a reflecting plane
ISO 8638 - Cardiovascular implants and EN ISO 8638 -
extracorporeal systems - Extracorporeal
blood circuit for haemodialysers,
haemodiafilters and haemofilters
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the
European Commission and the European Free Trade Association, and within its scope the
Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of
14 June 1993 concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling
within the scope of this standard.
IEC 60601-2-16 ®
Edition 4.0 2012-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-16: Particular requirements for the basic safety and essential performance
of haemodialysis, haemodiafiltration and haemofiltration equipment
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 11.040.20;11.040.25 ISBN 978-2-8322-0042-1
– 2 – 60601-2-16 © IEC:2012
CONTENTS
FOREWORD. 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 12
201.5 General requirements for testing of ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 16
201.7 ME EQUIPMENT identification, marking and documents . 16
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 19
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
201.10 Protection against unwanted and excessive radiation HAZARDS . 21
201.11 Protection against excessive temperatures and other HAZARDS . 21
201.12 * Accuracy of controls and instruments and protection against hazardous
outputs . 22
201.13 HAZARDOUS SITUATIONS and fault conditions . 30
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 31
201.15 Construction of ME EQUIPMENT . 31
201.16 * ME SYSTEMS . 32
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 33
202 Electromagnetic compatibility – Requirements and tests . 33
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 33
210 Process requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS . 35
211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 35
Annexes . 35
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 36
Annex AA (informative) Particular guidance and rationale . 37
Annex BB (informative) Examples of HAZARDS, foreseeable sequences of events, and
HAZARDOUS SITUATIONS in HAEMODIALYSIS EQUIPMENT . 55
Bibliography . 63
Index of defined terms used in this particular standard . 64
Figure 201.101 – Continuous air infusion test set-up with example dimensions . 28
Figure AA.1 – Example of the HAEMODIALYSIS ME SYSTEM . 51
Table 201.101 – ESSENTIAL PERFORMANCE requirements . 12
Table AA.1: Possible ALARM CONDITION priorities according to 6.1.2 of
IEC 60601-1-8:2006, . 53
Table BB.1 – Hazardous situation list following ISO 14971:2007, Annex E .
...
SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN 60601-2-16:1998
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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 version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-2-16:1998 NOTE Harmonized as EN 60601-2-16:1998 (not modified).
IEC 60601-2-39 NOTE Harmonized as EN 60601-2-39.
ISO 11197 NOTE Harmonized as EN ISO 11197.
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.
Annex ZA of EN 60601-1:2006 applies with the following exceptions:
Publication Year Title EN/HD Year
Replacement :
IEC 60601-1-2 2007 Medical electrical equipment - Part 1-2: EN 60601-1-2 2007
General requirements for basic safety and
essential performance - Collateral
+ corr March 2010
standard: Electromagnetic compatibility -
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
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
+ corr March 2010
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
Addition:
IEC 60601-1-10 2007 Medical electrical equipment - Part 1-10: EN 60601-1-10 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for the
development of physiologic closed-loop
controllers
IEC 60601-1-11 2010 Medical electrical equipment - Part 1-11: EN 60601-1-11 2010
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 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices
ISO 594-2 - Conical fittings with 6 % (Luer) taper for
syringes, needles and certain other
medical equipment - Part 2: Lock fittings
ISO 3744 - Acoustics - Determination of sound power EN ISO 3744 -
levels and sound energy levels of noise
sources using sound pressure -
Engineering methods for an essentially
free field over a reflecting plane
ISO 8638 - Cardiovascular implants and EN ISO 8638 -
extracorporeal systems - Extracorporeal
blood circuit for haemodialysers,
haemodiafilters and haemofilters
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the
European Commission and the European Free Trade Association, and within its scope the
Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of
14 June 1993 concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling
within the scope of this standard.
IEC 60601-2-16 ®
Edition 4.0 2012-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-16: Particular requirements for the basic safety and essential performance
of haemodialysis, haemodiafiltration and haemofiltration equipment
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 11.040.20;11.040.25 ISBN 978-2-8322-0042-1
– 2 – 60601-2-16 © IEC:2012
CONTENTS
FOREWORD. 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 12
201.5 General requirements for testing of ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 16
201.7 ME EQUIPMENT identification, marking and documents . 16
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 19
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
201.10 Protection against unwanted and excessive radiation HAZARDS . 21
201.11 Protection against excessive temperatures and other HAZARDS . 21
201.12 * Accuracy of controls and instruments and protection against hazardous
outputs . 22
201.13 HAZARDOUS SITUATIONS and fault conditions . 30
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 31
201.15 Construction of ME EQUIPMENT . 31
201.16 * ME SYSTEMS . 32
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 33
202 Electromagnetic compatibility – Requirements and tests . 33
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 33
210 Process requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS . 35
211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 35
Annexes . 35
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 36
Annex AA (informative) Particular guidance and rationale . 37
Annex BB (informative) Examples of HAZARDS, foreseeable sequences of events, and
HAZARDOUS SITUATIONS in HAEMODIALYSIS EQUIPMENT . 55
Bibliography . 63
Index of defined terms used in this particular standard . 64
Figure 201.101 – Continuous air infusion test set-up with example dimensions . 28
Figure AA.1 – Example of the HAEMODIALYSIS ME SYSTEM . 51
Table 201.101 – ESSENTIAL PERFORMANCE requirements . 12
Table AA.1: Possible ALARM CONDITION priorities according to 6.1.2 of
IEC 60601-1-8:2006, . 53
Table BB.1 – Hazardous situation list following ISO 14971:2007, Annex E . 55
60601-2-16 © IEC:2012 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
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MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for the basic safety and
essential performance of haemodialysis, haemodiafiltration
and haemo
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