IEC 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.

General Information

• Status: Published
• Publication Date: 31-Jan-1998
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 25-Apr-2008

Relations

• Revised: IEC 60601-2-16:2008 - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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

Reference number
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the 60000 series.

Consolidated publications
Consolidated versions of some IEC publications including amendments are available. For example,

edition numbers 1.0, 1.1 and 1.2 refer, res- pectively, to the base publication, the base publication

incorporating amendment 1 and the base publication incorporating amendments 1 and 2.

Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC, thus ensuring that

the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available in the IEC
catalogue.
Information on the revision work, the issue of revised editions and amendments may be obtained from
IEC National Committees and from the following IEC sources:
• IEC Bulletin
• IEC Yearbook
On-line access*
• Catalogue of IEC publications
Published yearly with regular updates
(On-line access)*
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International Electrotechnical Vocabulary
(IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for general use, readers are referred
to publications IEC 60027: Letter symbols to be used in electrical technology, IEC 60417: Graphical symbols for
use on equipment. Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols for
diagrams.
IEC publications prepared by the same technical committee
The attention of readers is drawn to the end pages of this publication which list the IEC publications issued by the
technical committee which has prepared the present publication.
* See web site address on title page.

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.
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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

– 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

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.

– 4 – 60601-2-16 © IEC:1998(E)

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.

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.

– 6 – 60601-2-16 © IEC:1998(E)

"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 P
...