IEC 60601-2-16:2012
(Main)Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Medical electrical equipment - Part 2-16: Particular requirements for 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.
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.
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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
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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
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for the basic safety and
essential performance of haemodialysis, haemodiafiltration
and haemofiltration equipment
FOREWORD
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International standard IEC 60601-2-16 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
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.
– 4 – 60601-2-16 © IEC:2012
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/972/FDIS 62D/987/RVD
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