EN 60601-2-16:1998

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

Specifies the minimum safety requirements for single patient haemodialysis, haemodiafiltration and haemofiltration equipment. These devices are intended for use either by medical staff or under the supervision of medical expertise, including haemodialysis, haemodiafiltration and haemofiltration equipment operated by the patient.

Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit von Hämodialyse-, Hämodiafiltrations- und Hämofiltrationsgeräte

Appareils électromédicaux - Partie 2-16: Règles particulières de sécurité pour les appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration

Medicinska električna oprema - 2-16. del: Posebne varnostne zahteve za opremo za hemodializo, hemodiafiltracijo in hemofiltracijo (IEC 60601-2-16:1998)

General Information

• Status: Withdrawn
• Publication Date: 08-Apr-1998
• ICS: 11.040 - Medical equipment
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 14-Apr-2018
• Completion Date: 14-Apr-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-16:1998 - Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998)

Relations

• Replaces: HD 395.2.16 S1:1989 - Medical electrical equipment - Part 2: Particular requirements for the safety of haemodialysis equipment
• Effective Date: 29-Jan-2023
• Replaced By: 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
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-16:1998
01-september-1998
1DGRPHãþD
SIST HD 395.2.16 S1:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]DRSUHPR
]DKHPRGLDOL]RKHPRGLDILOWUDFLMRLQKHPRILOWUDFLMR,(&
Medical electrical equipment - Part 2-16: Particular requirements for the safety of
haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998)
Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit
von Hämodialyse-, Hämodiafiltrations- und Hämofiltrationsgeräte (IEC 60601-2-16:1998)
Appareils électromédicaux - Partie 2-16: Règles particulières de sécurité pour les
appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration (CEI 60601-2-16:1998)
Ta slovenski standard je istoveten z: EN 60601-2-16:1998
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN 60601-2-16:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-16:1998

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SIST EN 60601-2-16:1998

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SIST EN 60601-2-16:1998

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SIST EN 60601-2-16:1998

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SIST EN 60601-2-16:1998

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SIST EN 60601-2-16:1998
INTERNATIONAL
IEC
STANDARD
60601-2-16
Second edition
1998-02
Medical electrical equipment –
Part 2-16:
Particular requirements for the safety
of haemodialysis, haemodiafiltration
and haemofiltration equipment
Appareils électromédicaux –
Partie 2-16:
Règles particulières de sécurité
pour les appareils d'hémodialyse,
d'hémodiafiltration et d'hémofiltration
 IEC 1998 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in
utilisée sous quelque forme que ce soit et par aucun any form or by any means, electronic or mechanical,
procédé, électronique ou mécanique, y compris la photo- including photocopying and microfilm, without permission in
copie et les microfilms, sans l'accord écrit de l'éditeur. writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http: //www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
PRICE CODE T
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue

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SIST EN 60601-2-16:1998
– 2 – 60601-2-16 © IEC:1998(E)
CONTENTS
Page
FOREWORD . 3
INTRODUCTION . 4
SECTION 1: GENERAL
Clause
1 Scope and object . 5
2 Terminology and definitions . 6
3 General requirements . 8
6 Identification, marking and documents . 8
SECTION 2: ENVIRONMENTAL CONDITIONS
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
19 Continuous LEAKAGE CURRENT and PATIENT AUXILIARY CURRENTS . 10
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility. 11
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection . 11
49 Interruption of the power supply . 12
SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output . 12
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
54 General . 18
56 Components and general assembly. 19
57 MAINS PARTS, components and layout . 19
ANNEXES
L – References – Publications mentioned in this standard . 20
AA (informative) General guidance and rationale. 21

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SIST EN 60601-2-16:1998
60601-2-16 © IEC:1998(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for the safety of haemodialysis,
haemodiafiltration and haemofiltration equipment
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization
for Standardization (ISO) in accordance with conditions determined by agreement between the two
organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical reports or guides and they are accepted by the National Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-16 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62D/254/FDIS 62D/271/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
Annex AA is for information only.
In this standard, the following print types are used:
– requirements, compliance with which can be tested and definitions: roman type;
– explanations, advice, notes, general statements and exceptions: smaller type;
– test specifications: italic type;
– TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH HAVE BEEN DEFINED IN CLAUSE 2
AND IN IEC 60601-1: SMALL CAPITALS.
A bilingual version of this standard may be issued at a later date.

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SIST EN 60601-2-16:1998
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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.
This particular standard does not take into consideration the specific safety aspects of systems
using regeneration of DIALYSING FLUID.
This particular standard amends and supplements IEC 60601-1 (second edition, 1988): Medical
electrical equipment – Part 1: General requirements for safety, as amended by its amendment
1 (1991) and amendment 2 (1995), hereinafter referred to as the General Standard (see 1.3).
The requirements are followed by specifications for the relevant tests.
Following the decision taken by subcommittee 62D at the meeting in Washington in 1979, a
"General guidance and rationale" section giving some explanatory notes, where appropriate,
about the more important requirements is included in annex AA.
Clauses or subclauses for which there are explanatory notes in annex AA are marked with an
asterisk (*).
It is considered that a knowledge of the reasons for these requirements will not only facilitate
the proper application of the standard but will, in due course, expedite any revision neces-
sitated by changes in clinical practice or as a result of developments in technology. However,
this annex does not form part of the requirements of this standard.

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SIST EN 60601-2-16:1998
60601-2-16 © IEC:1998(E) – 5 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for the safety of haemodialysis,
haemodiafiltration and haemofiltration equipment
SECTION 1: GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This particular standard specifies the minimum safety requirements for single PATIENT
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT (as defined in 2.101).
These devices are intended for use either by medical staff or under the supervision of medical
expertise, including HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT
operated by the PATIENT. These particular requirements do not apply to
– EXTRACORPOREAL CIRCUITS,
– DIALYSERS,
– DIALYSING FLUID CONCENTRATES,
– water purification EQUIPMENT,
–EQUIPMENT used to perform peritoneal dialysis (see IEC 60601-2-39).
1.3 Particular standards
Addition:
This particular standard refers to IEC 60601-1 (1988): Medical electrical equipment – Part 1:
General requirements for safety as amended by its amendment 1 (1991) and amendment 2
(1995).
For brevity IEC 60601-1 is referred to in this particular standard either as the "General
Standard" or as the "General Requirement(s)".
The numbering of sections, clauses and subclauses of this particular standard corresponds to
that of the General Standard. 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 is replaced
completely by the text of this particular standard.
"Addition" means that the clause or subclause of this particular standard is additional to the
requirements of the General Standard.

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"Amendment" means that the clause or subclause of the General Standard is amended as
indicated by the text of this particular standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa),
bb), etc.
The term "this standard" is used to make reference to the General Standard and this particular
standard taken together.
Where there is no corresponding section, clause or subclause in this particular standard, the
section, clause or subclause of the General Standard, although possibly not relevant, applies
without modification; where it is intended that any part of the General Standard, although
possibly relevant, is not to be applied, a statement to that effect is given in this particular
standard.
1.5 Collateral standards
IEC 60601-1-2 applies (see clause 36).
2 Terminology and definitions
This clause of the General Standard applies except as follows:
2.1.5 APPLIED PART
Replacement:
The EXTRACORPOREAL CIRCUIT and the DIALYSING FLUID circuit and/or all parts permanently and
conductively connected to it.
2.2.15 MEDICAL ELECTRICAL EQUIPMENT (hereinafter referred to as EQUIPMENT)
Addition:
Under the scope of this particular standard EQUIPMENT means HAEMODIALYSIS, HAEMO-
DIAFILTRATION and/or HAEMOFILTRATION EQUIPMENT.
Additional definitions:
2.101 HAEMODIALYSIS, HAEMODIAFILTRATION and/or HAEMOFILTRATION EQUIPMENT
A system or combination of units used to perform HAEMODIALYSIS, HAEMODIAFILTRATION and/or
HAEMOFILTRATION (also refer to 2.2.15).
2.102 HAEMODIALYSIS (HD)
Process whereby solute imbalances in a PATIENT's blood are corrected mainly by diffusion
across a semi-permeable membrane.
NOTE – This process normally includes fluid removal.
2.103 HAEMOFILTRATION (HF)
A process whereby solute imbalances of a PATIENT's blood are corrected mainly by filtration
across a semi-permeable membrane.
NOTE – This process includes fluid exchange and normally fluid removal.

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2.104 HAEMODIAFILTRATION (HDF)
A process whereby solute imbalances in a PATIENT's blood are corrected by means of
simultaneous filtration and diffusion across a semi-permeable membrane.
NOTE – This process includes fluid exchange and normally fluid removal.
2.105 BUFFER-FREE HAEMODIAFILTRATION
A specific form of HDF where the buffer is not given to the PATIENT with the DIALYSING FLUID, but
with the SUBSTITUTION FLUID.
2.106 DIALYSER
For the purpose of this particular standard, the term DIALYSER is used to describe any device
containing a semi-permeable membrane that is used to perform HD/HDF/HF.
2.107 DIALYSING FLUID
A solution which is intended to exchange solutes and/or water with blood during HD/HDF.
NOTE – The words "dialysate" and "dialysis fluid" are commonly used as synonyms of DIALYSING FLUID.
2.108 DIALYSING FLUID CONCENTRATE
A solution of chemicals which, when appropriately diluted, produces the DIALYSING FLUID.
2.109 SUBSTITUTION FLUID
A fluid which during HF or HDF is administered to the PATIENT via the EXTRACORPOREAL CIRCUIT.
2.110 ULTRAFILTRATION
The process of fluid removal from the PATIENT's blood across the DIALYSER.
2.111 EXTRACORPOREAL CIRCUIT
Blood lines and any integral ACCESSORY thereof.
2.112 TRANSMEMBRANE PRESSURE (TMP)
Hydrostatic PRESSURE exerted across a semi-permeable membrane.
NOTE – For practical reasons the mean TMP is generally expressed as either
a) the difference between the arithmetic mean of inlet and outlet PRESSURES of the blood and DIALYSING FLUID
compartments of a DIALYSER, or
b) the difference between the arithmetic mean of the inlet and outlet PRESSURES of the blood compartment, and the
filtrate PRESSURE of a haemofilter or a haemoconcentrator.
2.113 BLOOD LEAK
A leakage of blood from the blood compartment to the DIALYSING FLUID compartment of the
DIALYSER due to a rupture of the semi-permeable membrane.
2.114 ARTERIAL PRESSURE
The PRESSURE measured in the EXTRACORPOREAL CIRCUIT between the PATIENT and the arterial
blood pump.

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2.115 VENOUS PRESSURE
The PRESSURE measured in the EXTRACORPOREAL CIRCUIT between the outlet from the DIALYSER
and the return to the PATIENT.
2.116 VENOUS PART
Part of the EXTRACORPOREAL CIRCUIT between the outlet of the DIALYSER and the PATIENT.
2.117 PROTECTIVE SYSTEM
An automatic system which senses a specified parameter (or parameters), or a constructional
feature, specifically designed to protect the PATIENT against SAFETY HAZARDS which may arise.
3 General requirements
This clause of the General Standard applies except as follows:
3.6
Addition:
j) Failure of a PROTECTIVE SYSTEM (see 51.101);
k) The following is not regarded as a SINGLE FAULT CONDITION:
Air in the EXTRACORPOREAL CIRCUIT.
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.8.1 General
Addition:
The ACCOMPANYING DOCUMENTS shall additionally include:
– a statement pointing out the importance of compliance with any local regulation in respect
of separation of devices in the water supply, back syphonage and the air clearance between
the EQUIPMENT waste connector and the drain.
6.8.2 Instructions for use
Addition:
aa) The instructions for use shall additionally include the following:
1) a statement that it is essential for the EQUIPMENT to be installed and used in compliance
with appropriate regulations/recommendations on quality of water and other relevant
fluids;
2) a statement of the importance of the quality of the protective earth in the installation
when CLASS I EQUIPMENT is used;
3) a statement of the applications in which a POTENTIAL EQUALIZATION CONDUCTOR should
be used;
4) a description of the method(s) by which disinfection or sterilization is achieved;
5) a statement that the test procedure by which the effectiveness of disinfection or
sterilization has been verified is available on request;

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6) a description of the range of inlet water PRESSURES, DIALYSING FLUID CONCENTRATE
supply PRESSURES, temperatures and flows necessary for operation of the EQUIPMENT;
7) a definition of TRANSMEMBRANE PRESSURE if the manufacturer makes use of one
different from that stated in 2.112;
  *8) a statement which draws the OPERATOR's attention to the precautions necessary to
prevent cross-infection between PATIENTS;
9) a statement which draws the OPERATOR's attention to the SAFETY HAZARDS associated
with connection and disconnection of the PATIENT;
10) a statement which draws the OPERATOR's attention to the potential SAFETY HAZARDS
arising from improper connections of the EXTRACORPOREAL CIRCUIT;
11) information on possible deviations from the intended ULTRAFILTRATION rate because of
single needle specific parameters as e.g. phase sensitive PRESSURE variations;
12) information on the delivered blood volume per time unit related to the pre-setting of the
EQUIPMENT for single needle treatments;
13) a statement that comments are available on request, concerning the expected
recirculation of the blood flow in the EXTRACORPOREAL CIRCUIT in single needle
treatments, if the recommended administration sets, DIALYSERS, fistula needles and
catheters are used;
14) information on DIALYSING FLUID CONCENTRATES intended to be used together with the
EQUIPMENT;
15) a statement on the SAFETY HAZARDS related to incorrect choice of DIALYSING FLUID
CONCENTRATE(S);
16) an explanation of the coloured markings on the concentrate connectors;
SAFETY HAZARDS ULTRAFILTRATION
17) statements on the potential  related to reverse ;
18) a statement about the limited sensitivity of a PROTECTIVE SYSTEM employed according to
51.104;
19) an explanation of the adequate OPERATOR action upon an alarm from any PROTECTIVE
SYSTEM;
20) a statement pointing out that, in override mode, the OPERATOR is responsible for
monitoring those parameters of any PROTECTIVE SYSTEM which are being overriden;
21) a statement on the possible SAFETY HAZARDS associated with external radio or
electromagnetic disturbance which may affect the safe operation of the EQUIPMENT.
6.8.3 Technical description
Addition:
aa) The technical description shall, additionally include the following:
1) the particular measures or conditions to be observed when installing the EQUIPMENT or
bringing it into use. These shall include guidance on the type and number of tests to be
carried out;
2) for EQUIPMENT that includes integral anti-coagulant pump(s): the type of the pump(s),
the range and the accuracy of the flow for such pump(s) and the PRESSURES against
which this accuracy is maintained;
3) for EQUIPMENT that includes integral blood pump(s): the range and accuracy of the flows
for such pump(s) and the inlet and outlet PRESSURE range over which this accuracy is
maintained;
  *4) the type, accuracy and limitations of the PROTECTIVE SYSTEM(S) required by 51.101;
5) the type and accuracy of the PROTECTIVE SYSTEM required by 51.102;
6) the method employed, range, accuracy and limitations for the PROTECTIVE SYSTEM
required by 51.103;

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7) the type and accuracy of the PROTECTIVE SYSTEM required by 51.104.1;
8) the method for the PROTECTIVE SYSTEM required by 51.104.2 and the sensitivity of the
PROTECTIVE SYSTEM at the minimum and maximum specified DIALYSING FLUID flow;
9) the type of the PROTECTIVE SYSTEM required by 51.104.3;
10) the type and the accuracy of the PROTECTIVE SYSTEM required by 51.105;
11) the method employed and the sensitivity under test conditions specified by the
manufacturer for the PROTECTIVE SYSTEM required by 51.106;
12) the type of the PROTECTIVE SYSTEM required by 51.111;
13) the override time(s) for any PROTECTIVE SYSTEM;
14) the audible alarm silence period;
15) the range of sound PRESSURE levels of any adjustable audible alarm source;
  *16) a disclosure of all materials intended to come into contact with the water, DIALYSING
FLUID and DIALYSING FLUID CONCENTRATE.
Compliance is checked by inspection.
SECTION 2: ENVIRONMENTAL CONDITIONS
The clauses and subclauses of this section of the General Standard apply.
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
19 Continuous LEAKAGE CURRENT and PATIENT AUXILIARY CURRENTS
This clause of the General Standard applies except as follows:
19.4 Tests
h) Measurement of the PATIENT LEAKAGE CURRENT
Addition:
12) The point of measurement shall be where both DIALYSING FLUID lines are connected or
where both extracorporeal blood lines are connected, whichever is worse. For the
duration of the test, a test solution with a conductivity of (14 ± 1) mS/cm, referenced to
a temperature of 25 °C, shall be flowing in the DIALYSING FLUID circuit and in the
EXTRACORPOREAL CIRCUIT. The EQUIPMENT shall be fully equipped for the intended use
as specified by the manufacturer.
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
The clauses and subclauses of this section of the General Standard apply.

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SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
The clauses and subclauses of this section of the General Standard apply except as follows:
36 Electromagnetic compatibility
Collateral standard IEC 60601-1-2 applies.
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
The clauses and subclauses of this section of the General Standard apply.
SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization
and disinfection
This clause of the General Standard applies except as follows:
44.3 Spillage
Replacement:
The EQUIPMENT shall be so constructed that in the event of spillage of liquids (causing
accidental wetting) no SAFETY HAZARD shall result.
Compliance is checked by the following test.
The EQUIPMENT is placed in the position of NORMAL USE and subjected for 30 s to an artificial
rainfall of 3 mm/min falling vertically from a height of 0,5 m above the top of the EQUIPMENT.
A test apparatus is shown in figure 3 of IEC 60529. The test is carried out using tap water. An
interrupting device may be used to determine the duration of the test. Immediately after the
30 s exposure, visible moisture on the BODY OF THE EQUIPMENT shall be removed.
Immediately after the above test, inspection shall show that the tap water which may have
entered the EQUIPMENT does not wet parts which may cause a SAFETY HAZARD. In case of
doubt, the EQUIPMENT shall be subjected to the dielectric strength test specified in clause 20 of
the General Standard and it shall function normally.
*44.4 Leakage
Replacement:
The liquid-carrying parts of the EQUIPMENT shall be so shielded against the electrical parts that
liquid which may leak under normal working PRESSURE does not lead to the PATIENT being
exposed to SAFETY HAZARDS, for example due to short-circuiting of CREEPAGE DISTANCES.
Compliance is checked by the following test.

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By means of a pipette, drops of tap water are applied to couplings, to seals and to hoses which
might rupture, moving parts being in operation or at rest, whichever is the less favourable.
After these procedures, the EQUIPMENT shall show no signs of wetting of uninsulated LIVE parts
or of electrical insulation which is liable to be adversely affected by tap water. In case of doubt,
the EQUIPMENT shall be subjected to the dielectric strength test as specified in clause 20 of the
General Standard.
The likelihood of other SAFETY HAZARDS is checked by inspection.
In case of doubt when using the above compliance test, the following test may be used.
The test is carried out using the liquid appropriate to that part of the EQUIPMENT. By means of a
syringe, a jet of the liquid is directed from couplings, from seals and from hoses that might
rupture, moving parts being in operation or at rest, whichever is the less favourable. After these
EQUIPMENT LIVE
procedures the shall show no signs of wetting of uninsulated parts or of
electrical insulation which is liable to be adversely affected by the liquid. In case of doubt, the
EQUIPMENT
shall be subjected to the dielectric strength test specified in clause 20 of the
General Standard.
44.7 Cleaning, sterilization and disinfection
Addition:
For EQUIPMENT employing non-disposable DIALYSING FLUID pathways, means shall be provided
for disinfection and/or sterilization to be carried out.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS and of the EQUIPMENT.
49 Interruption of the power supply
This clause of the General Standard applies except as follows:
Addition:
49.5 In the event of an interruption of the power supply to the EQUIPMENT, the following safe
conditions shall be achieved:
– activation of an audible alarm, lasting for at least 1 min (see 51.107);
– stopping of the DIALYSING FLUID flow to the DIALYSER;
– interruption of any SUBSTITUTION FLUID flow;
– reduction of ULTRAFILTRATION to its minimum value.
Compliance is checked by inspection and by functional tests.
SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
The clauses and subclauses of this section of the General Standard apply except as follows:
51 Protection against hazardous output
This clause of the General Standard applies except as follows:

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SIST EN 60601-2-16:1998
60601-2-16 © IEC:1998(E) – 13 –
51.2 Indication of parameters relevant to safety
Addition:
If the EQUIPMENT can be used for different operation modes, the selected operation mode shall
be obvious to the OPERATOR.
Compliance is checked by inspection.
*51.101 DIALYSING FLUID composition
a) The EQUIPMENT shall include a PROTECTIVE SYSTEM, independent of any fluid preparation
control system, which prevents the DIALYSING FLUID from reaching the DIALYSER, which, due
to its composition, may cause a SAFETY HAZARD.
NOTE – An acceptable method of complying with this requirement is for example a PROTECTIVE SYSTEM utilizing
measurement of conductivity by a temperature compensated (25 °C) method.
b) Operation of the PROTECTIVE SYSTEM shall achieve the following safe conditions:
– activation of an audible and visual alarm (see 51.107);
– stopping of the DIALYSING FLUID flow to the DIALYSER.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS and by functional tests.
*51.102 DIALYSING FLUID and SUBSTITUTION FLUID temperature
a) The EQUIPMENT shall include a PROTECTIVE SYSTEM, independent of any temperature control
system, which prevents the DIALYSING FLUID from reaching the DIALYSER and the
SUBSTITUTION FLUID from reaching the blood at a temperature higher than 41 °C, measured
at the EQUIPMENT DIALYSING FLUID and/or SUBSTITUTION FLUID outlet.
b) Operation of the PROTECTIVE SYSTEM shall achieve the following safe conditions:
– activation of an audible and visual alarm (see 5
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