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
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
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
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: 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: 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 particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title: Medical electrical
equipment, can be found on the IEC website.
60601-2-16 © IEC:2012 – 5 –
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – 60601-2-16 © IEC:2012
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of HAEMODIALYSIS,
HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT.
60601-2-16 © IEC:2012 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for the basic safety and
essential performance of haemodialysis, haemodiafiltration
and haemofiltration equipment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Addition:
BASIC SAFETY and ESSENTIAL PERFORMANCE of
This International Standard applies to the
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as
HAEMODIALYSIS EQUIPMENT.
This International Standard 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
AEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety.
H
This International Standard 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.
This International Standard includes all ME EQUIPMENT that is intended to deliver a
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT suffering
from kidney failure.
The particular requirements in this International standard do not apply to:
EXTRACORPOREAL CIRCUITS;
–
– DIALYSERS;
DIALYSIS FLUID CONCENTRATES;
–
– water treatment equipment;
PERITONEAL DIALYSIS (see IEC 60601-2-39).
– equipment used to perform
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
AZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
H
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of IEC 60601-1.
NOTE See also 4.2 of IEC 60601-1:2005.
___________
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
– 8 – 60601-2-16 © IEC:2012
201.1.2 Object
Replacement:
The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for HAEMODIALYSIS EQUIPMENT
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of IEC 60601-1, and Clause 201.2 of this International Standard.
IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-10 and IEC 60601-11 apply as modified in
Clauses 202, 208, 210 and 211 respectively. IEC 60601-1-3 does not apply. All other
published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over IEC 60601-1.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
60601-2-16 © IEC:2012 – 9 –
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding, clause or subclause in this particular standard, the clause
or subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 63.
Clause 2 of the general standard applies, except as follows:
Amendment:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
safety and essential performance – Collateral 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: 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: 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 engineering to medical devices
ISO 594-2, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other
medical equipment – Part 2: Lock fittings
ISO 3744, Acoustics – Determination of sound power levels of noise sources using sound
pressure – Engineering method in an essentially free field over a reflecting plane
ISO 8638, Cardiovascular implants and artificial organs – Extracorporeal blood circuit for
haemodialysers, haemodiafilters and haemofilters
– 10 – 60601-2-16 © IEC:2012
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, and
IEC 60601-1-10:2007 apply, except as follows:
NOTE An index of defined terms is found beginning on page 64.
201.3.8
*APPLIED PART
Replacement:
EXTRACORPOREAL CIRCUIT and all parts permanently and conductively connected to it (e.g.
DIALYSIS FLUID circuit)
Note 1 to entry: See Figure AA.1 in Annex AA.
201.3.78
PATIENT CONNECTION
Addition:
Note 1 to entry: The PATIENT blood lines connectors are the individual points on the APPLIED PART through which
current can flow between the PATIENT and the HAEMODIALYSIS EQUIPMENT in NORMAL CONDITION or SINGLE FAULT
CONDITION.
Additions:
201.3.201
ARTERIAL PRESSURE
pressure measured in the blood withdrawal line of the EXTRACORPOREAL CIRCUIT
Note 1 to entry: A difference can be made between the pre-pump pressure, which is upstream of the blood pump,
and post pump pressure, which is downstream of the blood pump .
201.3.202
*BLOOD LEAK
leakage of blood from the blood compartment to the DIALYSIS FLUID compartment of the
DIALYSER
Note 1 to entry: When performing an HF process, this involves the filtration fluid section.
201.3.203
CENTRAL DELIVERY SYSTEM
part of a ME SYSTEM which proportions DIALYSIS FLUID CONCENTRATE and water for distribution
as DIALYSIS FLUID to the HAEMODIALYSIS EQUIPMENT or distributes DIALYSIS FLUID CONCENTRATE
201.3.204
DIALYSER
a device containing a semi-permeable membrane that is used to perform HD, HDF or HF
201.3.205
DIALYSIS FLUID
solution intended to exchange solutes and/or water with blood during HD or HDF
Note 1 to entry: The words "dialysate", “dialysis solution” and "dialysing fluid" are commonly used as synonyms of
DIALYSIS FLUID.
201.3.206
DIALYSIS FLUID CONCENTRATE
substances which, when appropriately diluted or dissolved with purified water, produce the
DIALYSIS FLUID
60601-2-16 © IEC:2012 – 11 –
201.3.207
EXTRACORPOREAL CIRCUIT
blood lines and any integral ACCESSORY thereof
201.3.208
HAEMODIAFILTRATION
HDF
process whereby concentrations of water-soluble substances in a PATIENT's blood and an
excess of fluid of a PATIENT with renal insufficiency are corrected by a simultaneous
combination of HD and HF
201.3.209
HAEMODIALYSIS
HD
process whereby concentrations of water-soluble substances in a PATIENT's blood and an
excess of fluid of a PATIENT with renal insufficiency are corrected by bidirectional diffusive
transport and ULTRAFILTRATION across a semi-permeable membrane separating the blood from
the DIALYSIS FLUID
Note 1 to entry: This process normally includes fluid removal by filtration. This process is usually also
accompanied by diffusion of substances from the DIALYSIS FLUID into the blood.
201.3.210
* HAEMODIALYSIS EQUIPMENT
ME EQUIPMENT or ME SYSTEM used to perform HAEMODIALYSIS, HAEMODIAFILTRATION and/or
HAEMOFILTRATION
Note 1 to entry: When the term ME EQUIPMENT is used in headings it is equivalent to HAEMODIALYSIS EQUIPMENT.
When the term ME EQUIPMENT is used in the text it is referring to a general ME EQUIPMENT.
201.3.211
HAEMOFILTRATION
HF
process whereby concentrations of water-soluble substances in a PATIENT's blood and an
excess of fluid of a PATIENT with renal insufficiency are corrected by unidirectional convective
transport via ULTRAFILTRATION across a semi-permeable membrane separating the blood from
the DIALYSIS FLUID AND ultrafiltrate is simultaneously replaced by an approximately isoosmolar
SUBSTITUTION FLUID at a rate such that the difference between the ULTRAFILTRATION rate and
the rate of SUBSTITUTION FLUID addition will lead to removal of the excess fluid over the course
of the treatment
201.3.212
NET FLUID REMOVAL
fluid loss from the PATIENT
Note 1 to entry: Historically this term was “weight loss”.
201.3.213
*ONLINE HDF
HAEMODIAFILTRATION procedure where the HAEMODIALYSIS EQUIPMENT, based on the DIALYSIS
FLUID, produces the SUBSTITUTION FLUID for the HDF treatment, suitable for injection
201.3.214
*ONLINE HF
HAEMOFILTRATION procedure where the HAEMODIALYSIS EQUIPMENT, based on the DIALYSIS
FLUID, produces the SUBSTITUTION FLUID for the HF treatment, suitable for injection
201.3.215
*PROTECTIVE SYSTEM
automatic system, or a constructional feature, specifically designed to protect the PATIENT
against HAZARDS which can arise
– 12 – 60601-2-16 © IEC:2012
201.3.216
SUBSTITUTION FLUID
a fluid administered to the PATIENT via the EXTRACORPOREAL CIRCUIT during HF or HDF
201.3.217
TRANSMEMBRANE PRESSURE
TMP
fluid pressure difference exerted across a semi-permeable membrane
Note 1 to entry: Generally the mean TMP is used. In practice, the displayed TRANSMEMBRANE PRESSURE is usually
estimated from the measured EXTRACORPOREAL CIRCUIT pressure and the measured DIALYSIS FLUID pressure, each
obtained at a single point.
201.3.218
*ULTRAFILTRATION
process of fluid removal from the PATIENT'S blood across the DIALYSER
201.3.219
VENOUS PRESSURE
pressure measured in the blood return line of the EXTRACORPOREAL CIRCUIT
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 * ESSENTIAL PERFORMANCE
Additional subclauses:
201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements
ESSENTIAL PERFORMANCE of HAEMODIALYSIS EQUIPMENT includes, but is not limited to the
functions found in the subclauses listed in Table 201.101, which shall be met within the
tolerances specified by the MANUFACTURER under NORMAL CONDITION, if applicable:
Table 201.101 – ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Blood flow 201.4.3.102
DIALYSIS FLUID flow 201.4.3.103
NET FLUID REMOVAL 201.4.3.104
SUBSTITUTION FLUID flow 201.4.3.105
Dialysis time 201.4.3.106
DIALYSIS FLUID composition 201.4.3.107
DIALYSIS FLUID temperature 201.4.3.108
SUBSTITUTION FLUID temperature 201.4.3.109
NOTE Some ESSENTIAL PERFORMANCES listed in Table 201.101 are dependent on the characteristics of the
disposable used (e.g. blood flow is dependent upon the pump segment inner diameter in rotary peristaltic pumps).
201.4.3.102 Blood flow
The blood flow for the HAEMODIALYSIS EQUIPMENT shall be as specified by the MANUFACTURER.
NOTE 1 Only a blood flow lower than the set value is considered as negative for the treatment. Therefore the goal
of testing is to find the highest negative blood flow error.
60601-2-16 © IEC:2012 – 13 –
Compliance is checked under the following test conditions for typical peristaltic pumps.
– Apply a pump segment to the HAEMODIALYSIS EQUIPMENT and let it run for at least 30 min.
– Apply a fluid (e.g. water) with a temperature of 37 °C in the EXTRACORPOREAL CIRCUIT.
– Set the blood flow of the HAEMODIALYSIS EQUIPMENT to 400 ml/min or – if not possible - to
the highest possible blood flow.
– Set the ARTERIAL PRESSURE to -200 mmHg.
– Measure the blood flow.
The values of the measured blood flow shall be within the tolerances specified by the
MANUFACTURER in the instructions for use.
NOTE 2 Pump segment fatigue can reduce the blood flow rate.
NOTE 3 The blood flow rate in peristaltic pumps can be affected by negative input pressures
201.4.3.103 DIALYSIS FLUID flow
The DIALYSIS FLUID flow for the DIALYSIS EQUIPMENT shall be as specified by the MANUFACTURER.
NOTE Only a DIALYSIS FLUID flow lower than the set value is considered as negative for the treatment.
Compliance is checked under the following test conditions.:
HAEMODIALYSIS EQUIPMENT to the HAEMODIALYSIS mode as specified by the
– Set the
MANUFACTURER.
– Set the HAEMODIALYSIS EQUIPMENT to maximum DIALYSIS FLUID flow.
Measure the DIALYSIS FLUID flow during 30 min.
– Set the HAEMODIALYSIS EQUIPMENT to minimum DIALYSIS FLUID flow.
– Measure the DIALYSIS FLUID flow during 30 min.
DIALYSIS FLUID flow shall be within the tolerances specified by the
The values of the
MANUFACTURER in the instructions for use.
201.4.3.104 NET FLUID REMOVAL
The NET FLUID REMOVAL for the HAEMODIALYSIS EQUIPMENT shall be as specified by the
MANUFACTURER.
Compliance is checked under the following test conditions.
Test 1 for the balancing part of the HAEMODIALYSIS EQUIPMENT only:
– Set the HAEMODIALYSIS EQUIPMENT in the HAEMODIALYSIS mode, if applicable, with a
DIALYSER according to the MANUFACTURER’s recommendation.
– Apply fluid (e.g. water) in THE EXTRACORPOREAL CIRCUIT.
– Set the highest DIALYSIS FLUID flow, if applicable.
– Set the DIALYSIS FLUID temperature to 37 °C, if applicable.
– Set the NET FLUID REMOVAL rate to 0 ml/h or the lowest adjustable value.
– Create a blood outlet pressure of 50 mmHg below the highest pressure specified by the
MANUFACTURER.
– Measure the NET FLUID REMOVAL during an appropriate time interval.
Continue with test 2:
– Set the NET FLUID REMOVAL rate to the maximum value.
– 14 – 60601-2-16 © IEC:2012
– Measure the NET FLUID REMOVAL during an appropriate time interval.
Continue with test 3:
– Create a blood outlet pressure 20 mmHg above the lowest specified pressure.
– Measure the NET FLUID REMOVAL during an appropriate time interval.
The values of the NET FLUID REMOVAL shall be within the tolerances specified by the
MANUFACTURER in the instructions for use.
201.4.3.105 SUBSTITUTION FLUID flow
For HAEMOFILTRATION and HAEMODIAFILTRATION equipment only:
The SUBSTITUTION FLUID flow for the HAEMODIALYSIS EQUIPMENT shall be as specified by the
MANUFACTURER.
NOTE Only a SUBSTITUTION FLUID flow lower than the set value is considered as negative for the treatment.
Compliance is checked under the following test conditions:
Test 1 for the balancing part of the HAEMODIALYSIS EQUIPMENT and of the therapeutic relevant
SUBSTITUTION FLUID flow:
– Set the HAEMODIALYSIS EQUIPMENT to the HDF or HF mode with a DIALYSER according to the
MANUFACTURER’s recommendation.
– Apply fluid (e.g. water) in the EXTRAXCORPOREAL CIRCUIT.
– Set the NET FLUID REMOVAL flow to 0 ml/h, or – if not possible – to the minimum.
– Set the maximum SUBSTITUTION FLUID flow.
– Set the temperature of the SUBSTITUTION FLUID to 37 °C, if applicable.
– Measure the SUBSTITUTION FLUID flow and the NET FLUID REMOVAL.
Continue with test 2:
– Set the minimum SUBSTITUTION FLUID flow.
– Measure the SUBSTITUTION FLUID flow and the NET FLUID REMOVAL.
The values of SUBSTITUTION FLUID flow and NET FLUID REMOVAL shall be within the tolerances
specified by the MANUFACTURER in the instructions for use.
201.4.3.106 Dialysis time
The accuracy of the dialysis time for the HAEMODIALYSIS EQUIPMENT shall be as specified by
the MANUFACTURER.
Compliance is checked by functional measurements relevant for the definition of dialysis time
specified by the MANUFACTURER.
201.4.3.107 * DIALYSIS FLUID composition
Test method specified by the MANUFACTURER.
201.4.3.108 DIALYSIS FLUID temperature
The DIALYSIS FLUID temperature for the HAEMODIALYSIS EQUIPMENT shall be as specified by the
MANUFACTURER.
60601-2-16 © IEC:2012 – 15 –
NOTE This test applies only to HAEMODIALYSIS EQUIPMENT having a heater for the DIALYSIS FLUID.
Compliance is checked under the following test conditions:
– Let the HAEMODIALYSIS EQUIPMENT run until it is in a thermally stable condition.
– The environmental temperature is within 20 °C to 25 °C.
– Set the DIALYSIS FLUID temperature to 37 °C, if applicable.
– Set the highest DIALYSIS FLUID flow.
– Measure the temperature at the DIALYSER inlet.
– Record the temperature during a period of 30 min.
– Set the lowest DIALYSIS FLUID flow.
– Measure the temperature at the DIALYSER inlet.
– Record the temperature during a period of 30 min.
The values of the DIALYSIS FLUID temperature shall be within the tolerances specified by the
MANUFACTURER in the instructions for use.
201.4.3.109 SUBSTITUTION FLUID temperature
The tolerances of the SUBSTITUTION FLUID temperature for the HAEMODIALYSIS EQUIPMENT shall
be as specified by the MANUFACTURER.
NOTE This test applies only to HAEMODIALYSIS EQUIPMENT having a heater for the SUBSTITUTION FLUID.
Compliance is checked under the following test conditions.
– Let the HAEMODIALYSIS EQUIPMENT run until it is in a thermally stable condition.
– The environmental temperature is within 20 °C to 25 °C.
– Set the SUBSTITUTION FLUID temperature to 37 °C, if applicable.
– Set the highest SUBSTITUTION FLUID flow.
– Measure the temperature of the SUBSTITUTION FLUID at the connection point of the
SUBSTITUTION FLUID line to the blood line.
– Record the temperature over a period of 30 min.
– Set the lowest SUBSTITUTION FLUID flow.
– Measure the temperature of the SUBSTITUTION FLUID at the connection point of the
SUBSTITUTION FLUID line to the blood line.
– Record the temperature over a period of 30 min.
The values of the SUBSTITUTION FLUID temperature shall be within the tolerances specified by
the MANUFACTURER in the instructions for use.
201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Addition:
An example of SINGLE FAULT CONDITION is a failure of a PROTECTIVE SYSTEM (see
201.12.4.4.101, 201.12.4.4.102, 201.12.4.4.103, 201.12.4.4.104, 201.12.4.4.105);
NOTE If air is permanently present in the EXTRACORPOREAL CIRCUIT when the HAEMODIALYSIS EQUIPMENT is used
as intended by the MANUFACTURER, the air is not regarded as a SINGLE FAULT CONDITION, but as NORMAL CONDITION.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies.
– 16 – 60601-2-16 © IEC:2012
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.4.3 Units of measure
Addition:
mmHg may be used for measurement of pressures in any part of the HAEMODIALYSIS
EQUIPMENT.
201.7.9.2 Instructions for use
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall additionally include the following, if applicable:
– a statement which draws the OPERATOR's attention to the precautions necessary to
prevent any cross-infection between PATIENTS;
– a statement which draws the OPERATOR's attention to the HAZARDs associated with
connection and disconnection of the PATIENT;
– a statement which draws the OPERATOR's attention to the potential HAZARDs including any
HAZARDOUS SITUATIONs arising from improper connections of the EXTRACORPOREAL CIRCUIT;
– a statement on the HAZARDS related to incorrect choice of DIALYSIS FLUID CONCENTRATE(S);
– a quantitative description of the possible deviation of each component of the DIALYSIS
FLUID in SINGLE FAULT CONDITION depending on the ALARM LIMITS of the PROTECTIVE SYSTEM;
– * a statement on the potential HAZARDS related to a possible transport of undesired
substances from the DIALYSIS FLUID compartment to the blood compartment of the
DIALYSER;
– for the PROTECTIVE SYSTEM employed according to 201.12.4.4.104 1a) Note 2:
• a warning stating that this PROTECTIVE SYSTEM reduces the HAZARD in part only and an
explanation of the remaining HAZARDs;
• a description of further measures to reduce the RISK;
OPERATOR action upon an alarm and potential HAZARDs, if
– an explanation of the adequate
the alarm is repeatedly cleared without solving the underlying problem.;
– * a warning specifying that any narrow passages in the EXTRACORPOREAL CIRCUIT (such as
kinks in the blood line or cannula that are too thin) may cause haemolysis and that this
HAZARDOUS SITUATION may not be detected by the PROTECTIVE SYSTEMS;
– if a PROTECTIVE SYSTEM, according to 201.12.4.4.105 a) Note 1, is applied: a warning
stating that improper functioning of an ultrasonic air detector may be caused by a
coagulum or the application of ultrasound gel;
– a warning stating that air may enter into the EXTRACORPOREAL CIRCUIT at connection points
downstream of the air detector, if pressures are negative; this can occur in cases such as
single needle applications or central venous catheter applications;
– for ONLINE HDF and ONLINE HF:
• a warning stating that only the disinfection procedures defined and validated by the
MANUFACTURER may be used for ONLINE HDF and ONLINE HF;
60601-2-16 © IEC:2012 – 17 –
• information on the required quality of the incoming water and of the DIALYSIS FLUID
CONCENTRATES used;
• intervals at which wearing parts (e.g. filter) should be exchanged;
– a warning that the blood flow and thus the treatment efficacy may be reduced when the
pre-pump ARTERIAL PRESSURE is extremely negative; and the range and accuracy of the
flow of such pump(s) and the inlet and outlet pressure range over which this accuracy is
maintained.
– for HAEMODIALYSIS EQUIPMENT with APPLIED PARTS other than TYPE CF APPLIED PARTS a
warning, addressed to both the OPERATOR and the RESPONSIBLE ORGANIZATION, to ensure
that no electrical equipment (non-ME EQUIPMENT and ME EQUIPMENT) with TOUCH CURRENTS
and PATIENT LEAKAGE CURRENTS above the respective limits for type CF APPLIED PARTS is
used in the PATIENT ENVIRONMENT in combination with central venous catheters with atrial
location.
NOTE For information see subclause 201.8.3 in Annex AA
201.7.9.2.5 ME EQUIPMENT description
Addition:
The instructions for use shall additionally include the following, if applicable:
– a definition of TRANSMEMBRANE PRESSURE if the MANUFACTURER makes use of one different
from that stated in 201.3.217;
– an explanation of the coloured markings on the DIALYSIS FLUID CONCENTRATE connectors;
– information on the effective delivered blood flow in single-needle treatments;
– information on the recirculation of blood in the EXTRACORPOREAL CIRCUIT in single-needle
treatments;
– the delay time after which an audible alarm is activated after interruption of the power
supply
– for PHYSIOLOGIC CLOSED-LOOP CONTROLLER functions:
a) the technical working principle;
b) the PATIENT pa
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