IEC 80601-2-49:2018
(Main)Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
IEC 80601-2-49:2018 applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment.
The scope of this document is restricted to ME equipment or medical electrical systems intended for connection to a single patient that has two or more physiological monitoring units.
For purposes of this document, a pregnant mother and her fetus(es) are considered a single patient.
This document does not specify requirements for individual physiological monitoring units such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological monitoring units specify requirements from the perspective of stand-alone ME equipment. This particular standard addresses the additional requirements related to multifunction patient monitors. Multifunction patient monitors can be integrated into other ME equipment or medical electrical systems. When this is the case, other relevant standards also apply.
This document does not apply to implantable parts of multifunction patient monitors.
This first edition cancels and replaces the second edition of IEC 60601-2-49, published in 2011. This edition constitutes a technical revision to align with the current edition and Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto. Major changes are in Clause 208 because many of the former requirements are now addressed by IEC 60601-1-8.
Appareils électromédicaux - Partie 2-49: Exigences particulières pour la sécurité de base et les performances essentielles des moniteurs multifonctions des patients
L’IEC 80601-2-49:2018 s'applique aux exigences pour la sécurité de base et les performances essentielles des moniteurs multifonctions des patients, désignés ci-après par appareils EM ou systèmes électromédicaux. La présente norme particulière s'applique aux moniteurs multifonctions des patients destinés à être utilisés dans les établissements professionnels de santé ainsi que dans l'environnement des services medicaux d'urgence ou dans l'environnement des soins à domicile.
Le domaine d'application du présent document est limité aux appareils EM ou aux systèmes électromédicaux destinés à la connexion à un patient unique qui comportent au minimum deux unités de surveillance physiologique.
Le présent document ne spécifie pas d'exigences pour les unités de surveillance physiologique individuelles telles que l'ECG, la pression prélevée directement et l'oxymétrie de pouls. Les normes particulières relatives à ces unités de surveillance physiologique spécifient des exigences dans la perspective d'appareils EM autonomes. La présente norme particulière aborde les exigences supplémentaires relatives aux moniteurs multifonctions des patients. Les moniteurs multifonctions des patients peuvent être intégrés dans d'autres appareils EM ou systèmes électromédicaux. Lorsque c'est le cas, d'autres normes s'appliquent également.
Le présent document ne s'applique pas aux parties implantables des moniteurs multifonctions des patients.
Cette première édition annule et remplace la deuxième édition de l'IEC 60601-2-49 parue en 2011. Cette édition constitue une révision technique et permet un alignement avec l'édition actuelle de l'IEC 60601-1 et son Amendement, ainsi qu'avec les nouvelles versions des normes collatérales et de leurs amendements. Les modifications majeures concernent l'Article 208, car une grande partie des exigences précédentes sont désormais traitées dans l'IEC 60601-1-8.
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IEC 80601-2-49
Edition 1.1 2024-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
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Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitors
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IEC 80601-2-49
Edition 1.1 2024-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitors
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.55 ISBN 978-2-8322-9710-0
REDLINE VERSION – 2 – IEC 80601-2-49:2018+AMD1:2024 CSV
© IEC 2024
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 19
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 19
202 Electromagnetic disturbances – Requirements and tests . 19
206 USABILITY . 24
208 General requirements, tests and guidance for ALARM SYSTEMS IN MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 24
Annexes . 28
Annex AA (informative) Particular guidance and rationale . 29
Bibliography . 38
Index of defined terms used in this particular standard . 39
Figure 201.101 – MULTIFUNCTION PATIENT MONITOR with single PATIENT circuit (6) with
multiple PHYSIOLOGICAL MONITORING UNITS and multiple PATIENT circuits (7) each with a
single PHYSIOLOGICAL MONITORING UNIT . 15
Figure 202.101 – Test layout for conducted and radiated EMISSIONS and IMMUNITY test . 20
Figure 202.102 – Test circuit for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 with PATIENT CONNECTIONS . 22
Figure 202.103 – Test setup for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 . 23
Figure 202.104 – Test circuit for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 with non-conductive APPLIED PART . 24
Figure AA.1 – Example of a pre-configured MULTIFUNCTION PATIENT MONITOR . 30
Figure AA.2 – Example of a modular MULTIFUNCTION PATIENT MONITOR . 30
Figure AA.3 – Example of a MULTIFUNCTION PATIENT MONITOR connected to
a central station . 30
© IEC 2024
Figure AA.4 – Example of a MULTIFUNCTION PATIENT MONITOR integrated into a ventilator . 31
Figure AA.5 – Single PATIENT circuit with multiple PHYSIOLOGICAL MONITORING UNITS and
PATIENT cables . 33
Table 201.101 – ESSENTIAL PERFORMANCE requirements. 12
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-49: Particular requirements for the basic safety and
essential performance of multifunction patient monitors
FOREWORD
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This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 80601-2-49 edition 1.1 contains the first edition (2018-03) [documents
62D/1547/FDIS and 62D/1559/RVD] and its amendment 1 (2024-09) [documents
62D/2146/FDIS and 62D/2164/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions are in green text, deletions are in strikethrough
red text. A separate Final version with all changes accepted is available in this
publication.
© IEC 2024
International standard IEC 80601-2-49 has been prepared by a Joint Working Group of IEC
subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical
equipment in medical practice, and of ISO subcommittee SC3: Lung ventilators and related
equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment.
This first edition cancels and replaces the second edition of IEC 60601-2-49, published in
2011. This edition constitutes a technical revision to align with the current edition and
Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto.
Major changes are in Clause 208 because many of the former requirements are now
addressed by IEC 60601-1-8.
It is published as a double logo standard.
Full information on the voting for the approval of this document can be found in the report on
voting indicated in the above table. In ISO, the standard has been approved by XXX P
members out of YYY having cast a vote.
In this document, 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 document, 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 document are preceded by the term "Clause" followed by
the clause number. References to subclauses within this particular standard are by number
only.
In this document, 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 document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance
with this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "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 80601 International Standard, published under the general title
Medical electrical equipment, can be found on the IEC website.
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© IEC 2024
The committee has decided that the contents of this document and its amendment will remain
unchanged until the stability date indicated on the IEC website under webstore.iec.ch in the
data related to the specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committees that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.
IMPORTANT – The "colour inside" logo on the cover page of this document 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
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© IEC 2024
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MULTIFUNCTION PATIENT MONITORS. It amends and supplements IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance, hereinafter referred to as the general standard.
The aim of this edition is to bring this particular standard up to date with reference to the
edition 3.1 of the general standard and new versions of collateral standards and amendments
thereto through technical changes.
The requirements of this particular standard take priority over those of the general standard.
A "Particular guidance and rationale" for the requirements of this particular standard is
included in Annex AA. It is considered that 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 necessitated by changes in clinical practice or as a result of developments in
technology. However, this Annex AA does not form part of the requirements of this document.
INTRODUCTION to Amendment 1
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
amendment projects within the IEC 60601-1 series. Those projects were all completed and
the amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised may be found within
the IEC document 62D/1792/DC. The results and comments on the DC may be found within
62D/1808/INF. The review report for this amendment is 62D/1835A/RR.
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MEDICAL ELECTRICAL EQUIPMENT –
Part 2-49: Particular requirements for the basic safety and
essential performance of multifunction patient monitors
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of the 80601 International Standard applies to BASIC SAFETY and
ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORS as defined in
201.3.201, hereafter referred to as ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. This
particular standard applies to MULTIFUNCTION PATIENT MONITORS intended for use in
professional healthcare facilities as well as in the EMERGENCY MEDICAL SERVICE ENVIRONMENT
HOME HEALTHCARE ENVIRONMENT.
or the
The scope of this document is restricted to ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS
intended for connection to a single PATIENT that has two or more PHYSIOLOGICAL MONITORING
UNITS.
NOTE For purposes of this document, a pregnant mother and her fetus(es) are considered a single PATIENT.
This document does not specify requirements for individual PHYSIOLOGICAL MONITORING UNITS
ECG, invasive pressure and pulse oximetry. The particular standards related to these
such as
PHYSIOLOGICAL MONITORING UNITS specify requirements from the perspective of stand-alone
ME EQUIPMENT. This particular standard addresses the additional requirements related to
MULTIFUNCTION PATIENT MONITORS.MULTIFUNCTION PATIENT MONITORS can be integrated into
other ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. When this is the case, other relevant
standards also apply.
EXAMPLE 1 MULTIFUNCTION PATIENT MONITOR incorporated into a critical care ventilator where ISO 80601-2-12
also applies.
EXAMPLE 2 MULTIFUNCTION PATIENT MONITOR incorporated into a homecare ventilator for dependent PATIENT
where ISO 80601-2-72 also applies.
EXAMPLE 3 MULTIFUNCTION PATIENT MONITOR incorporated into anesthetic workstation where ISO 80601-2-13 also
applies.
EXAMPLE 4 MULTIFUNCTION PATIENT MONITOR incorporated into haemodialysis equipment, IEC 60601-2-16 also
applies.
This document does not apply to implantable parts of MULTIFUNCTION PATIENT MONITORS.
201.1.2 Object
Replacement:
The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for MULTIFUNCTION PATIENT MONITORS as defined in 201.3.201.
______________
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
© IEC 2024
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-
6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, as well as IEC 60601-1-8:2006,
IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020 apply as modified in
Clauses 202, 206 and 208 respectively. IEC 60601-1-3 and IEC 60601-1-9 do 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
MULTIFUNCTION PATIENT MONITORS under consideration, and may add other BASIC SAFETY and
ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 are 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 document 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, 208.6 in this particular standard addresses the content of Clause 6 of the
IEC 60601-1-8 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 3.147154, additional definitions in this document are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
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, 208 for IEC 60601-1-8, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
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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 38.
Clause 2 of the general standard applies, except as follows.
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
IEC 60601-1-2:2014/AMD1:2020
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-6:2010/AMD2:2020
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
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-8:2006/AMD2:2020
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989/AMD1:1999
IEC 60529:1989/AMD2:2013
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-1-11:2015, 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 60601-1-11:2015/AMD1:2020
IEC 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems intended for use in the emergency
medical services environment
IEC 60601-1-12:2014/AMD1:2020
IEC 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories
© IEC 2024
IEC 60601-2-27:2011, Medical electrical equipment – Part 2-27, Particular requirements for
the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60601-2-34:2011, Medical electrical equipment – Part 2-34, Particular requirements for
the basic safety and essential performance of invasive blood pressure monitoring equipment
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1, IEC
60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-1-12, IEC 60601-2-2,
IEC 60601-2-27, IEC 60601-2-34 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 39.
Addition:
201.3.201
* MULTIFUNCTION PATIENT MONITOR
modular or pre-configured ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS whose primary
intended function is monitoring of a single PATIENT, has more than one
PHYSIOLOGICAL MONITORING UNIT, either displays those information or distributes the
information for remote display, and either includes an ALARM SYSTEM or is a component of a
DISTRIBUTED ALARM SYSTEM
201.3.202
PHYSIOLOGICAL MONITORING UNIT
part of the MULTIFUNCTION PATIENT MONITOR whose purpose is to collect physiological signal(s)
from a single sensor type and to process it for monitoring
EXAMPLE 1 The pulse oximetry signal can provide information about oxygen saturation, pulse rate, perfusion,
etc.
EXAMPLE 2 The signals from ECG ELECTRODES can provide information about ECG and thoracic respiration rate.
Note 1 to entry: Examples of physiological signals include (a) electrocardiography, (b) non-invasive blood
pressure, (c) invasive blood pressure, (d) pulse oximetry, (e) temperature, (f) electroencephalography, (g)
transcutaneous gas analysis, and (h) respiratory gas analysis. Each of these is a single physiological signal within
the meaning of this definition.
Note 2 to entry: It is recognized that more than one variable or parameter may be derived from a single
physiological signal.
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Additional subclause:
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201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements for MULTIFUNCTION PATIENT MONITORS are
found in subclauses listed in Table 201.101.
Table 201.101 – ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Displaying data according PRIMARY OPERATING FUNCTIONS 206.101 c)
Determination of ALARM CONDITIONS and assignment of priority 208.6.1.2
Indication of validity of measured values 208.6.3.2.101
or generating a TECHNICAL ALARM CONDITION 208.6.1.2
a
or failure that is readily identifiable by the OPERATOR
a
Examples of failures readily identifiable by the OPERATOR are a completely non-
functional MULTIFUNCTION PATIENT MONITOR, a completely non-functional
PHYSIOLOGICAL MONITORING UNIT, etc.
201.4.5 * Alternative RISK CONTROL measures or test methods for ME EQUIPMENT or ME
SYSTEMS
Addition before the first paragraph:
When several particular standards simultaneously apply to a MULTIFUNCTION PATIENT MONITOR,
BASIC SAFETY
all relevant requirements from those standards shall be applied as applicable to
and ESSENTIAL PERFORMANCE. If requirements from particular standards are in conflict, the
RISK MANAGEMENT PROCESS shall be used to identify which standard’s requirement applies.
While performing this PROCESS, MANUFACTURERS are strongly recommended to give the
requirements of this particular standard additional weight whenever possible.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.4 Other conditions
Addition:
If necessary for the purpose of conducting the test, the INTERNAL ELECTRICAL POWER SOURCE
may be replaced by an external battery or a DC power supply to provide the necessary test
voltage, for tests according to 201.11.8.101.
The values used in test circuits, unless otherwise specified, shall have at least an accuracy as
given below:
– resistors: ±1 %;
– capacitors: ±10 %;
– inductors: ±10 %;
– test voltages: ±1 %.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
© IEC 2024
201.6.2 * Protection against electric shock
Replacement of the last paragraph:
APPLIED PARTS associated with MULTIFUNCTION PATIENT MONITOR shall be classified as TYPE BF
or TYPE CF APPLIED PARTS (see 7.2.10 and 8.3 of the general standard). APPLIED PARTS shall
be classified as DEFIBRILLATION-PROOF APPLIED PARTS (see 8.5.5 of the general standard),
unless other applicable particular standards permit non-DEFIBRILLATION-PROOF APPLIED PARTS
for the respective PHYSIOLOGICAL MONITORING UNIT or technical limitations prevent the design
DEFIBRILLATION-PROOF APPLIED PARTS.
of
201.6.6 Mode of operation
Replacement:
MULTIFUNCTION PATIENT MONITORS shall be classified for CONTINUOUS OPERATION (see 7.2.11).
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
Additional subclause:
201.7.2.101 Connectors for APPLIED PARTS
Connectors on a MULTIFUNCTION PATIENT MONITOR intended to connect APPLIED PARTS shall be
marked to identify the APPLIED PARTS that can be connected.
NOTE Examples of markings are MODEL OR TYPE REFERENCE of the APPLIED PART, function of the APPLIED PART
(e.g. ECG, ECG/respiration, SpO2, temperature, etc.) or color coding.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall include a warning that defibrillator protection requires use of
MANUFACTURER specified APPLIED PARTS, PATIENT CABLES, LEAD WIRES, TRANSDUCERS and
ACCESSORIES.
201.7.9.2.9 Operating instructions
Additional subclause:
201.7.9.2.9.101 Additional instructions for use
The instructions for use shall include the following:
a) that the use of the MULTIFUNCTION PATIENT MONITOR is restricted to one PATIENT at a time;
PATIENT, if APPLIED PARTS not being
b) precautions to take when using a defibrillator on a
protected against the effects of defibrillation are being used; a description of how the
discharge of a defibrillator affects the MULTIFUNCTION PATIENT MONITOR;
c) information indicating whether the MULTIFUNCTION PATIENT MONITOR incorporates means to
PATIENT against burns when used with HIGH-FREQUENCY (HF) SURGICAL
protect the
EQUIPMENT and advice regarding the location of ELECTRODES, TRANSDUCERS, etc. to reduce
the HAZARDS of burns in the event of a defect in the NEUTRAL ELECTRODE connection of the
HF SURGICAL EQUIPMENT;
REDLINE VERSION – 14 – IEC 80601-2-49:2018+AMD1:2024 CSV
© IEC 2024
d) advice and PROCEDURES regarding testing of the MULTIFUNCTION PATIENT MONITOR and
ACCESSORIES on a daily basis (by the clinical OPERATOR).
e) identification of PHYSIOLOGICAL MONITORING UNIT(S) with which the MULTIFUNCTION PATIENT
is intended to be used;
MONITOR
f) simple fault-finding methods for troubleshooting problems by which the clinical OPERATOR
can locate problems if the MULTIFUNCTION PATIENT MONITOR appears to be functioning
incorrectly;
g) the subsequent operation of the MULTIFUNCTION PATIENT MONITOR after interruption of the
SUPPLY MAINS exceeding 30 s (see 201.11.8);
ALARM SETTINGS and configurations of the ALARM SYSTEM when
h) advice on the preferred
INTENDED USE includes the monitoring of PATIENTS that are not continuously attended by a
clinical OPERATOR;
i) * description of how to invoke an ALARM SIGNAL inactivation state for TECHNICAL ALARM
if sensors, probes, or modules are intentionally disconnected by the clinical
CONDITIONS
OPERATOR;
j) the adjustment ranges of the ALARM LIMITS and the resolution of ALARM LIMIT settings;
k) advice on preferred ALARM SETTINGS and ALARM PRESETS of the ALARM SYSTEM by PATIENT
population as needed.
Compliance is checked by inspection of the instructions for use.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.3 Classification of APPLIED PARTS
Replacement of item c):
c) An APPLIED PART not covered by a) or b) shall be a TYPE BF APPLIED PART or TYPE CF
APPLIED PART.
201.8.5.2.3 * PATIENT leads or PATIENT cables
Addition after the note:
Any connector for electrical connections on a PATIENT lead or PATIENT cable that is at the end
of the lead or cable remote from the MULTIFUNCTION PATIENT MONITOR shall be so constructed
that conductive parts of said connector cannot be connected to earth or possible hazardous
voltage while PATIENT CONNECTIONS of any APPLIED PART, not separated by at least one MEANS
OF PATIENT PROTECTION for a WORKING VOLTAGE equal to the MAXIMUM MAINS VOLTAGE, contact
the PATIENT (see Figure 201.101).
© IEC 2024
4 5
2 6
8 9
8 9
IEC
Key
① MULTIFUNCTION PATIENT MONITOR
② Insulation barrier (MOPP) of the PATIENT circuit with multiple (3) PHYSIOLOGICAL MONITORING UNITS
Insulation barriers (MOPP) of multiple PATIENT circuits (3) each with a single
③
PHYSIOLOGICAL MONITORING UNIT
④ PATIENT CABLE
⑤ LEAD WIRES
⑥ Single PATIENT circuit with multiple (3) PHYSIOLOGICAL MONITORING UNITS
Multiple PATIENT circuits (3) each with a single PHYSIOLOGICAL MONITORING UNIT separated from
⑦
each other by at least one MEANS OF PATIENT PROTECTION for a WORKING VOLTAGE equal to the
MAXIMUM MAINS VOLTAGE
Extension cable
⑧
⑨ PATIENT or sensor cable
Connectors at the end of the extension cables, sensor cables, PATIENT CABLES and PATIENT leads
remote from the PATIENT
Connectors at the end of the extension cables, sensor cables, PATIENT CABLES and PATIENT leads
remote from the MULTIFUNCTION PATIENT MONITOR
PATIENT CONNECTIONS
•
Figure 201.101 – MULTIFUNCTION PATIENT MONITOR with single PATIENT circuit (6) with
multiple PHYSIOLOGICAL MONITORING UNITS and multiple PATIENT circuits (7) each with a
single PHYSIOLOGICAL MONITORING UNIT
REDLINE VERSION – 16 – IEC 80601-2-49:2018+AMD1:2024 CSV
© IEC 2024
201.8.5.5.1 * Defibrillation protection
Replacement of last dash in a):
– any unused or disconnected connector at the MULTIFUNCTION PATIENT MONITOR for the
connection of APPLIED PART(S). MULTIFUNCTION PATIENT MONITORS that is completely BODY-
WORN (e.g. a Holter monitor) is exempt from this requirement.
Addition at the end of b):
Additionally, the MULTIFUNCTION PATIENT MONITOR shall resume normal operation in the
previous operating mode, without loss of any OPERATOR settings or stored data, and shall
continue to provide BASIC SAFETY and ESSENTIAL PERFORMANCE.
NOTE 101 The recovery time can be defined in other particular standards
Addition:
aa) MULTIFUNCTION PATIENT MONITORS shall be energized for the common-mode test and
differential mode test.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.6.5 * Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
Addition:
TRANSPORTABLE MULTIFUNCTION PATIENT MONITORS or TRANSPORTABLE parts of the
MULTIFUNCTION PATIENT MONITORS separable while remaining functioning shall have an ingress
protection of at least IPX1 so that, in the event of accidental wetting, no loss of BASIC SAFETY
or ESSENTIAL PERFORMANCE results from the ingress of liquids
Compliance is checked by the following test:
Expose the TRANSPORTABLE MULTIFUNCTION PATIENT MONITOR to wetting according of
IEC 60529:1989, IEC 60529:1989/AMD1:1999 and IEC 60529:1989/AMD2:2013.
Immediately after exposure, remove any visible moisture on the ENCLOSURE and confirm that
BASIC SAFETY and ESSENTIAL PERFORMANCE of this document are maintained.
201.11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Replacement:
© IEC 2024
If the SUPPLY MAINS to the MULTIFUNCTION PATIENT MONITOR is interrupted for 30 s or less, no
change of clinical OPERATOR settings shall occur, including the mode of operation, and all
stored PATIENT data shall remain available.
NOTE The MULTIFUNCTION PATIENT MONITOR does not have to be operating during the interruption of the SUPPLY
MAINS.
Compliance is checked by observing the MULTIFUNCTION PATIENT MONITOR operating mode,
OPERATOR settings, and stored data and interrupting the SUPPLY MAINS for a period of between
25 s and 30 s by disconnecting the POWER SUPPLY CORD.
If the SUPPLY MAINS is interrupted for more than 30 s, the subsequent operation shall be one of
the following:
– reversion to the MANUFACTURER’s default settings,
– reversion to the previous RESPONSIBLE ORGANIZATION’S default settings or
– reversion to the last settings used.
Means may be provided to the OPERATOR to select one or more than one of the above options.
Compliance is be checked by functional test.
If the MULTIFUNCTION PATIENT MONITOR contains an INTERNAL ELECTRICAL POWER SOURCE and
the SUPPLY MAINS is interrupted, the MULTIFUNCTION PATIENT MONITOR shall continue normal
operation by switching automatically to operating from its INTERNAL ELECTRICAL POWER
SOURCE, and the mode of operation, all OPERATOR settings and stored data shall not be
changed. Power-saving measures may be taken provided the MULTIFUNCTION PATIENT MONITOR
continues to conform to this particular standard.
Compliance is checked by interrupting the SUPPLY MAINS and observing that OPERATOR
settings and stored data are not changed and that normal operation continues. The ‘on-off’
switch needs to remain in the ‘on’ position.
Additional subclause:
201.11.8.101 Protection against depletion of the INTERNAL ELECTRICAL POWER SOURCE
A MULTIFUNCTION PATIENT MONITOR powered from an INTERNAL ELECTRICAL POWER SOURCE shall
not cause a HAZARDOUS SITUATION to the PATIENT when the state of discharge can no longer
maintain the NORMAL USE of the MULTIFUNCTION PATIENT MONITOR (see 201.15.4.4.101).
a) A MULTIFUNCTION PATIENT MONITOR shall provide a TECHNICAL ALARM CONDITION at least
5 min prior to the time that the MULTIFUNCTION PATIENT MONITOR can no longer function in
accordance with the MANUFACTURER’s specification when powered from the
INTERNAL ELECTRICAL POWER SOURCE.
b) When the state of discharge of any INTERNAL ELECTRICAL POWER SOURCE is such that the
MULTIFUNCTION PATIENT MONITOR can no longer function in accordance with the
MANUFACTURER’s specification, the MULTIFUNCTION PATIENT MONITOR shall power down in a
manner which causes no HAZARDOUS SITUATION to the PATIENT other than loss of function.
Compliance is checked by functional testing while operating the
MULTIFUNCTION PATIENT MONITOR from the INTERNAL ELECTRICAL POWER SOURCE.
201.12 Accuracy of controls and instruments and protection against hazardous
outputs
Clause 12 of the general standard applies, except as follows:
REDLINE VERSION – 18 – IEC 80601-2-49:2018+AMD1:2024 CSV
© IEC 2024
201.12.3 ALARM SYSTEMS
Replacement:
A MULTIFUNCTION PATIENT MONITOR that includes an ALARM SYSTEM or is component of a
DISTRIBUTED ALARM SYSTEM shall comply with Clause 208 of this particular standard.
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
Clause 13 of the general standard applies.
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Clause 14 of the general standard applies.
201.15 Construction of ME EQUIPMENT
Clause 15 of the general standard applies, except as follows:
201.15.1 Arrangements of controls and indicators of ME EQUIPMENT
Additional subclauses:
201.15.101 Display of PATIENT data
Displayed data (PATIENT data, visual ALARM SIGNALS and visual INFORMATION SIGNALS) shall be
CLEARLY LEGIBLE from the intended position of the OPERATOR.
NOTE PATIENT data include real-time waves, numeric values, trends and their time intervals, diagrams and signal
quality indicators.
If abbreviations are used, they shall be explained in the in
...
IEC 80601-2-49
Edition 1.0 2018-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitors
Appareils électromédicaux –
Partie 2-49: Exigences particulières pour la sécurité de base et les performances
essentielles des moniteurs multifonctions des patients
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IEC 80601-2-49
Edition 1.0 2018-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitors
Appareils électromédicaux –
Partie 2-49: Exigences particulières pour la sécurité de base et les performances
essentielles des moniteurs multifonctions des patients
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-5359-5
– 2 – IEC 80601-2-49:2018 © IEC 2018
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 19
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 19
202 Electromagnetic disturbances – Requirements and tests . 19
206 USABILITY . 24
208 General requirements, tests and guidance for ALARM SYSTEMS IN MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 25
Annexes . 28
Annex AA (informative) Particular guidance and rationale . 29
Bibliography . 38
Index of defined terms used in this particular standard . 39
Figure 201.101 – MULTIFUNCTION PATIENT MONITOR with single PATIENT circuit (6) with
multiple PHYSIOLOGICAL MONITORING UNITS and multiple PATIENT circuits (7) each with a
single PHYSIOLOGICAL MONITORING UNIT . 15
Figure 202.101 – Test layout for conducted and radiated EMISSIONS and IMMUNITY test . 20
Figure 202.102 – Test circuit for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 with PATIENT CONNECTIONS . 22
Figure 202.103 – Test setup for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 . 23
Figure 202.104 – Test circuit for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 with non-conductive APPLIED PART . 24
Figure AA.1 – Example of a pre-configured MULTIFUNCTION PATIENT MONITOR . 30
Figure AA.2 – Example of a modular MULTIFUNCTION PATIENT MONITOR . 30
Figure AA.3 – Example of a MULTIFUNCTION PATIENT MONITOR connected to a central
station . 30
Figure AA.4 – Example of a MULTIFUNCTION PATIENT MONITOR integrated into a ventilator . 31
Figure AA.5 – Single PATIENT circuit with multiple PHYSIOLOGICAL MONITORING UNITS and
PATIENT cables . 33
Table 201.101 – ESSENTIAL PERFORMANCE requirements. 12
– 4 – IEC 80601-2-49:2018 © IEC 2018
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-49: Particular requirements for the basic safety and
essential performance of multifunction patient monitors
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
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6) All users should ensure that they have the latest edition of this publication.
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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 80601-2-49 has been prepared by a Joint Working Group of IEC
subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical
equipment in medical practice, and of ISO subcommittee SC3: Lung ventilators and related
equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment.
This first edition cancels and replaces the second edition of IEC 60601-2-49, published in
2011. This edition constitutes a technical revision to align with the current edition and
Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto.
Major changes are in Clause 208 because many of the former requirements are now
addressed by IEC 60601-1-8.
It is published as a double logo standard.
The text of this standard is based on the following documents:
FDIS Report on voting
62D/1547/FDIS 62D/1559/RVD
Full information on the voting for the approval of this document can be found in the report on
voting indicated in the above table. In ISO, the standard has been approved by XXX P
members out of YYY having cast a vote.
In this document, 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 document, 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 document are preceded by the term "Clause" followed by
the clause number. References to subclauses within this particular standard are by number
only.
In this document, 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 document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance
with this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "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 80601 International Standard, published under the general title
Medical electrical equipment, can be found on the IEC website.
– 6 – IEC 80601-2-49:2018 © IEC 2018
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committees that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MULTIFUNCTION PATIENT MONITORS. It amends and supplements IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance, hereinafter referred to as the general standard.
The aim of this edition is to bring this particular standard up to date with reference to the
edition 3.1 of the general standard and new versions of collateral standards and amendments
thereto through technical changes.
The requirements of this particular standard take priority over those of the general standard.
A "Particular guidance and rationale" for the requirements of this particular standard is
included in Annex AA. It is considered that 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 necessitated by changes in clinical practice or as a result of developments in
technology. However, this Annex AA does not form part of the requirements of this document.
– 8 – IEC 80601-2-49:2018 © IEC 2018
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-49: Particular requirements for the basic safety and
essential performance of multifunction patient monitors
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of the 80601 International Standard applies to BASIC SAFETY and
ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORS as defined in
201.3.201, hereafter referred to as ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. This
particular standard applies to MULTIFUNCTION PATIENT MONITORS intended for use in
professional healthcare facilities as well as in the EMERGENCY MEDICAL SERVICE ENVIRONMENT
HOME HEALTHCARE ENVIRONMENT.
or the
The scope of this document is restricted to ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS
intended for connection to a single PATIENT that has two or more PHYSIOLOGICAL MONITORING
UNITS.
NOTE For purposes of this document, a pregnant mother and her fetus(es) are considered a single PATIENT.
This document does not specify requirements for individual PHYSIOLOGICAL MONITORING UNITS
such as ECG, invasive pressure and pulse oximetry. The particular standards related to these
PHYSIOLOGICAL MONITORING UNITS specify requirements from the perspective of stand-alone
ME EQUIPMENT. This particular standard addresses the additional requirements related to
MULTIFUNCTION PATIENT MONITORS.MULTIFUNCTION PATIENT MONITORS can be integrated into
other ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. When this is the case, other relevant
standards also apply.
EXAMPLE 1 MULTIFUNCTION PATIENT MONITOR incorporated into a critical care ventilator where ISO 80601-2-12
also applies.
EXAMPLE 2 MULTIFUNCTION PATIENT MONITOR incorporated into a homecare ventilator for dependent PATIENT
where ISO 80601-2-72 also applies.
EXAMPLE 3 MULTIFUNCTION PATIENT MONITOR incorporated into anesthetic workstation where ISO 80601-2-13 also
applies.
EXAMPLE 4 MULTIFUNCTION PATIENT MONITOR incorporated into haemodialysis equipment, IEC 60601-2-16 also
applies.
This document does not apply to implantable parts of MULTIFUNCTION PATIENT MONITORS.
201.1.2 Object
Replacement:
The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for MULTIFUNCTION PATIENT MONITORS as defined in 201.3.201.
______________
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014, IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, as well as
IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012 apply as modified in Clauses 202,
206 and 208 respectively. IEC 60601-1-3 and IEC 60601-1-9 do 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
MULTIFUNCTION PATIENT MONITORS under consideration, and may add other BASIC SAFETY and
ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are 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 document 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, 208.6 in this particular standard addresses the content of Clause 6 of the
IEC 60601-1-8 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 3.147, additional definitions in this document are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
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, 208 for IEC 60601-1-8, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
– 10 – IEC 80601-2-49:2018 © IEC 2018
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 38.
Clause 2 of the general standard applies, except as follows.
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
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 60601-1-6:2010/AMD1:2013
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
IEC 60601-1-8:2006/AMD1:2012
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989/AMD1:1999
IEC 60529:1989/AMD2:2013
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1-11:2015, 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 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems intended for use in the emergency
medical services environment
IEC 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories
IEC 60601-2-27:2011, Medical electrical equipment – Part 2-27, Particular requirements for
the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60601-2-34:2011, Medical electrical equipment – Part 2-34, Particular requirements for
the basic safety and essential performance of invasive blood pressure monitoring equipment
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1, IEC
60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-2-2, IEC 60601-2-27, IEC 60601-2-34
and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 39.
Addition:
201.3.201
* MULTIFUNCTION PATIENT MONITOR
modular or pre-configured ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS whose primary
PATIENT, has more than one
intended function is monitoring of a single
PHYSIOLOGICAL MONITORING UNIT, either displays those information or distributes the
information for remote display, and either includes an ALARM SYSTEM or is a component of a
DISTRIBUTED ALARM SYSTEM
201.3.202
PHYSIOLOGICAL MONITORING UNIT
part of the MULTIFUNCTION PATIENT MONITOR whose purpose is to collect physiological signal(s)
from a single sensor type and to process it for monitoring
EXAMPLE 1 The pulse oximetry signal can provide information about oxygen saturation, pulse rate, perfusion,
etc.
EXAMPLE 2 The signals from ECG ELECTRODES can provide information about ECG and thoracic respiration rate.
Note 1 to entry: Examples of physiological signals include (a) electrocardiography, (b) non-invasive blood
pressure, (c) invasive blood pressure, (d) pulse oximetry, (e) temperature, (f) electroencephalography, (g)
transcutaneous gas analysis, and (h) respiratory gas analysis. Each of these is a single physiological signal within
the meaning of this definition.
Note 2 to entry: It is recognized that more than one variable or parameter may be derived from a single
physiological signal.
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Additional subclause:
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements for MULTIFUNCTION PATIENT MONITORS are
found in subclauses listed in Table 201.101.
– 12 – IEC 80601-2-49:2018 © IEC 2018
Table 201.101 – ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Displaying data according PRIMARY OPERATING FUNCTIONS 206.101 c)
Determination of ALARM CONDITIONS and assignment of priority 208.6.1.2
Indication of validity of measured values 208.6.3.2.101
or generating a TECHNICAL ALARM CONDITION 208.6.1.2
a
or failure that is readily identifiable by the OPERATOR
a
Examples of failures readily identifiable by the OPERATOR are a completely non-
functional MULTIFUNCTION PATIENT MONITOR, a completely non-functional
PHYSIOLOGICAL MONITORING UNIT, etc.
201.4.5 * Alternative RISK CONTROL measures or test methods for ME EQUIPMENT or ME
SYSTEMS
Addition before the first paragraph:
When several particular standards simultaneously apply to a MULTIFUNCTION PATIENT MONITOR,
all relevant requirements from those standards shall be applied as applicable to BASIC SAFETY
and ESSENTIAL PERFORMANCE. If requirements from particular standards are in conflict, the
RISK MANAGEMENT PROCESS shall be used to identify which standard’s requirement applies.
While performing this PROCESS, MANUFACTURERS are strongly recommended to give the
requirements of this particular standard additional weight whenever possible.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.4 Other conditions
Addition:
If necessary for the purpose of conducting the test, the INTERNAL ELECTRICAL POWER SOURCE
may be replaced by an external battery or a DC power supply to provide the necessary test
voltage, for tests according to 201.11.8.101.
The values used in test circuits, unless otherwise specified, shall have at least an accuracy as
given below:
– resistors: ±1 %;
– capacitors: ±10 %;
– inductors: ±10 %;
– test voltages: ±1 %.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 * Protection against electric shock
Replacement of the last paragraph:
APPLIED PARTS associated with MULTIFUNCTION PATIENT MONITOR shall be classified as TYPE BF
or TYPE CF APPLIED PARTS (see 7.2.10 and 8.3 of the general standard). APPLIED PARTS shall
be classified as DEFIBRILLATION-PROOF APPLIED PARTS (see 8.5.5 of the general standard),
unless other applicable particular standards permit non-DEFIBRILLATION-PROOF APPLIED PARTS
for the respective PHYSIOLOGICAL MONITORING UNIT or technical limitations prevent the design
DEFIBRILLATION-PROOF APPLIED PARTS.
of
201.6.6 Mode of operation
Replacement:
MULTIFUNCTION PATIENT MONITORS shall be classified for CONTINUOUS OPERATION (see 7.2.11).
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
Additional subclause:
201.7.2.101 Connectors for APPLIED PARTS
Connectors on a MULTIFUNCTION PATIENT MONITOR intended to connect APPLIED PARTS shall be
marked to identify the APPLIED PARTS that can be connected.
NOTE Examples of markings are MODEL OR TYPE REFERENCE of the APPLIED PART, function of the APPLIED PART
(e.g. ECG, ECG/respiration, SpO , temperature, etc.) or color coding.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall include a warning that defibrillator protection requires use of
MANUFACTURER specified APPLIED PARTS, PATIENT CABLES, LEAD WIRES, TRANSDUCERS and
ACCESSORIES.
201.7.9.2.9 Operating instructions
Additional subclause:
201.7.9.2.9.101 Additional instructions for use
The instructions for use shall include the following:
a) that the use of the MULTIFUNCTION PATIENT MONITOR is restricted to one PATIENT at a time;
b) precautions to take when using a defibrillator on a PATIENT, if APPLIED PARTS not being
protected against the effects of defibrillation are being used; a description of how the
discharge of a defibrillator affects the MULTIFUNCTION PATIENT MONITOR;
c) information indicating whether the MULTIFUNCTION PATIENT MONITOR incorporates means to
protect the PATIENT against burns when used with HIGH-FREQUENCY (HF) SURGICAL
EQUIPMENT and advice regarding the location of ELECTRODES, TRANSDUCERS, etc. to reduce
the HAZARDS of burns in the event of a defect in the NEUTRAL ELECTRODE connection of the
HF SURGICAL EQUIPMENT;
d) advice and PROCEDURES regarding testing of the MULTIFUNCTION PATIENT MONITOR and
ACCESSORIES on a daily basis (by the clinical OPERATOR).
e) identification of PHYSIOLOGICAL MONITORING UNIT(S) with which the MULTIFUNCTION PATIENT
MONITOR is intended to be used;
– 14 – IEC 80601-2-49:2018 © IEC 2018
f) simple fault-finding methods for troubleshooting problems by which the clinical OPERATOR
can locate problems if the MULTIFUNCTION PATIENT MONITOR appears to be functioning
incorrectly;
g) the subsequent operation of the MULTIFUNCTION PATIENT MONITOR after interruption of the
SUPPLY MAINS exceeding 30 s (see 201.11.8);
h) advice on the preferred ALARM SETTINGS and configurations of the ALARM SYSTEM when
INTENDED USE includes the monitoring of PATIENTS that are not continuously attended by a
clinical OPERATOR;
i) * description of how to invoke an ALARM SIGNAL inactivation state for TECHNICAL ALARM
CONDITIONS if sensors, probes, or modules are intentionally disconnected by the clinical
OPERATOR;
j) the adjustment ranges of the ALARM LIMITS and the resolution of ALARM LIMIT settings;
k) advice on preferred ALARM SETTINGS and ALARM PRESETS of the ALARM SYSTEM by PATIENT
population as needed.
Compliance is checked by inspection of the instructions for use.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.3 Classification of APPLIED PARTS
Replacement of item c):
APPLIED PART not covered by a) or b) shall be a TYPE BF APPLIED PART or TYPE CF
c) An
APPLIED PART.
201.8.5.2.3 * PATIENT leads or PATIENT cables
Addition after the note:
PATIENT lead or PATIENT cable that is at the end
Any connector for electrical connections on a
of the lead or cable remote from the MULTIFUNCTION PATIENT MONITOR shall be so constructed
that conductive parts of said connector cannot be connected to earth or possible hazardous
voltage while PATIENT CONNECTIONS of any APPLIED PART, not separated by at least one MEANS
OF PATIENT PROTECTION for a WORKING VOLTAGE equal to the MAXIMUM MAINS VOLTAGE, contact
the PATIENT (see Figure 201.101).
4 5
2 6
8 9
8 9
IEC
Key
MULTIFUNCTION PATIENT MONITOR
①
Insulation barrier (MOPP) of the PATIENT circuit with multiple (3) PHYSIOLOGICAL MONITORING UNITS
②
Insulation barriers (MOPP) of multiple PATIENT circuits (3) each with a single
③
PHYSIOLOGICAL MONITORING UNIT
PATIENT CABLE
④
LEAD WIRES
⑤
Single PATIENT circuit with multiple (3) PHYSIOLOGICAL MONITORING UNITS
⑥
Multiple PATIENT circuits (3) each with a single PHYSIOLOGICAL MONITORING UNIT separated from
⑦
each other by at least one MEANS OF PATIENT PROTECTION for a WORKING VOLTAGE equal to the
MAXIMUM MAINS VOLTAGE
Extension cable
⑧
PATIENT or sensor cable
⑨
Connectors at the end of the extension cables, sensor cables, PATIENT CABLES and PATIENT leads
remote from the PATIENT
Connectors at the end of the extension cables, sensor cables, PATIENT CABLES and PATIENT leads
remote from the MULTIFUNCTION PATIENT MONITOR
PATIENT CONNECTIONS
•
Figure 201.101 – MULTIFUNCTION PATIENT MONITOR with single PATIENT circuit (6) with
multiple PHYSIOLOGICAL MONITORING UNITS and multiple PATIENT circuits (7) each with a
single PHYSIOLOGICAL MONITORING UNIT
– 16 – IEC 80601-2-49:2018 © IEC 2018
201.8.5.5.1 * Defibrillation protection
Replacement of last dash in a):
– any unused or disconnected connector at the MULTIFUNCTION PATIENT MONITOR for the
connection of APPLIED PART(S). MULTIFUNCTION PATIENT MONITORS that is completely BODY-
WORN (e.g. a Holter monitor) is exempt from this requirement.
Addition at the end of b):
Additionally, the MULTIFUNCTION PATIENT MONITOR shall resume normal operation in the
previous operating mode, without loss of any OPERATOR settings or stored data, and shall
continue to provide BASIC SAFETY and ESSENTIAL PERFORMANCE.
NOTE 101 The recovery time can be defined in other particular standards
Addition:
aa) MULTIFUNCTION PATIENT MONITORS shall be energized for the common-mode test and
differential mode test.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.6.5 * Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
Addition:
TRANSPORTABLE MULTIFUNCTION PATIENT MONITORS or TRANSPORTABLE parts of the
MULTIFUNCTION PATIENT MONITORS separable while remaining functioning shall have an ingress
protection of at least IPX1 so that, in the event of accidental wetting, no loss of BASIC SAFETY
or ESSENTIAL PERFORMANCE results from the ingress of liquids
Compliance is checked by the following test:
Expose the TRANSPORTABLE MULTIFUNCTION PATIENT MONITOR to wetting according of
IEC 60529:1989, IEC 60529:1989/AMD1:1999 and IEC 60529:1989/AMD2:2013.
Immediately after exposure, remove any visible moisture on the ENCLOSURE and confirm that
BASIC SAFETY and ESSENTIAL PERFORMANCE of this document are maintained.
201.11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Replacement:
If the SUPPLY MAINS to the MULTIFUNCTION PATIENT MONITOR is interrupted for 30 s or less, no
change of clinical OPERATOR settings shall occur, including the mode of operation, and all
stored PATIENT data shall remain available.
NOTE The MULTIFUNCTION PATIENT MONITOR does not have to be operating during the interruption of the SUPPLY
MAINS.
Compliance is checked by observing the MULTIFUNCTION PATIENT MONITOR operating mode,
OPERATOR settings, and stored data and interrupting the SUPPLY MAINS for a period of between
25 s and 30 s by disconnecting the POWER SUPPLY CORD.
If the SUPPLY MAINS is interrupted for more than 30 s, the subsequent operation shall be one of
the following:
– reversion to the MANUFACTURER’s default settings,
– reversion to the previous RESPONSIBLE ORGANIZATION’S default settings or
– reversion to the last settings used.
Means may be provided to the OPERATOR to select one or more than one of the above options.
Compliance is be checked by functional test.
If the MULTIFUNCTION PATIENT MONITOR contains an INTERNAL ELECTRICAL POWER SOURCE and
the SUPPLY MAINS is interrupted, the MULTIFUNCTION PATIENT MONITOR shall continue normal
operation by switching automatically to operating from its INTERNAL ELECTRICAL POWER
SOURCE, and the mode of operation, all OPERATOR settings and stored data shall not be
changed. Power-saving measures may be taken provided the MULTIFUNCTION PATIENT MONITOR
continues to conform to this particular standard.
Compliance is checked by interrupting the SUPPLY MAINS and observing that OPERATOR
settings and stored data are not changed and that normal operation continues. The ‘on-off’
switch needs to remain in the ‘on’ position.
Additional subclause:
201.11.8.101 Protection against depletion of the INTERNAL ELECTRICAL POWER SOURCE
A MULTIFUNCTION PATIENT MONITOR powered from an INTERNAL ELECTRICAL POWER SOURCE shall
not cause a HAZARDOUS SITUATION to the PATIENT when the state of discharge can no longer
maintain the NORMAL USE of the MULTIFUNCTION PATIENT MONITOR (see 201.15.4.4.101).
a) A MULTIFUNCTION PATIENT MONITOR shall provide a TECHNICAL ALARM CONDITION at least
5 min prior to the time that the MULTIFUNCTION PATIENT MONITOR can no longer function in
accordance with the MANUFACTURER’s specification when powered from the
INTERNAL ELECTRICAL POWER SOURCE.
b) When the state of discharge of any INTERNAL ELECTRICAL POWER SOURCE is such that the
MULTIFUNCTION PATIENT MONITOR can no longer function in accordance with the
MANUFACTURER’s specification, the MULTIFUNCTION PATIENT MONITOR shall power down in a
manner which causes no HAZARDOUS SITUATION to the PATIENT other than loss of function.
Compliance is checked by functional testing while operating the
MULTIFUNCTION PATIENT MONITOR from t
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