IEC 60601-2-49:2011

IEC 60601-2-49


®


Edition 2.0 2011-02



INTERNATIONAL



STANDARD



NORME
INTERNATIONALE


Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitoring equipment

Appareils électromédicaux –
Partie 2-49: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance multifonction des patients



IEC 60601-2-49:2011

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IEC 60601-2-49


®


Edition 2.0 2011-02



INTERNATIONAL



STANDARD



NORME
INTERNATIONALE


Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitoring equipment

Appareils électromédicaux –
Partie 2-49: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance multifonction des patients


INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XA
ICS 11.040.55 ISBN 978-2-88912-369-8

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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CONTENTS

FOREWORD . 4


INTRODUCTION . 7

201.1 Scope, object and related standards . 8

201.2 Normative references . 10


201.3 Terms and definitions . 10

201.4 General requirements . 11

201.5 General requirements for testing of ME EQUIPMENT . 12

201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents. 12
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 . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 18
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 18
202 Electromagnetic compatibility – Requirements and tests . 18
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 26
Annexes . 32
Annex AA (informative) General guidance and rationale . 33
Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 . 43
ANNEX CC (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT . 46
Bibliography . 49
Index of defined terms used in this particular standard. 50


Figure 202.101 – Test layout for conducted and radiated emission and radiated
immunity test with non-conductive APPLIED PART . 20
Figure 202.102 – Test layout for radiated and conducted emission test and radiated
immunity test with a PATIENT CONNECTION . 21
Figure 202.103 –Test circuit for HF surgery protection measurement according to
subclause 202.6.2.1.101 with PATIENT CONNECTIONS . 24
Figure 202.104 – Test setup for HF surgery protection measurement according to
subclause 202.6.2.1.101 . 25
Figure 202.105 – Test circuit for HF surgery protection measurement according to
subclause 202.6.2.1.101 with non-conductive APPLIED PART . 26
Figure AA.1 – Single APPLIED PART with MULTIPLE FUNCTIONS and PATIENT CONNECTIONS . 35

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60601-2-49  IEC:2011 – 3 –


Figure AA.2 – Single APPLIED PART (6) with MULTIPLE FUNCTIONS and

PATIENT CONNECTIONS and multiple APPLIED PARTS (7) with SINGLE FUNCTIONS and

PATIENT CONNECTIONS . 36

Figure BB.1 – NON-LATCHING ALARM SIGNALS without ALARM RESET . 43


Figure BB.2 – NON-LATCHING ALARM SIGNALS with ALARM RESET . 44

Figure BB.3 – LATCHING ALARM SIGNALS with ALARM RESET . 44

Figure BB.4 – Two ALARM CONDITIONS with ALARM RESET . 45

Figure CC.1 – PART LEAKAGE CURRENT measurement of TYPE BF APPLIED PARTS with

MULTIPLE FUNCTIONS . 46


Figure CC.2 – PART LEAKAGE CURRENT measurement of TYPE CF APPLIED PARTS with
MULTIPLE FUNCTIONS . 47
Figure CC.3 – Total PATIENT LEAKAGE CURRENT of TYPE BF and CF APPLIED PARTS with
MULTIPLE FUNCTIONS caused by an external voltage on the PATIENT CONNECTIONS . 48

Table 201.101 – ESSENTIAL PERFORMANCE requirements . 11
Table 208.101 – ALARM CONDITION priorities . 27
Table 208.102 – Characteristics of the BURST of auditory ALARM SIGNALS . 28

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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 monitoring equipment





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
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
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2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-49 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition of IEC 60601-2-49, published in
2001. This edition constitutes a technical revision to the new structure of IEC 60601-1:2005
(third edition).

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60601-2-49  IEC:2011 – 5 –


The text of this particular standard is based on the following documents:

FDIS Report on voting


62D/886/FDIS 62D/908/RVD



Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table.


This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.


In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;

– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

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The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data

related to the specific publication. At this date, the publication will be


• reconfirmed,

• withdrawn,

• replaced by a revised edition, or

• amended.

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60601-2-49  IEC:2011 – 7 –


INTRODUCTION


This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of

MULTIFUNCTION PATIENT MONITORING EQUIPMENT. It amends and supplements IEC 60601-1

(third edition, 2005): Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance), hereinafter referred to as the general standard.


The aim of this second edition is to bring this particular standard up to date with reference to

the third edition of the general standard through reformatting and technical changes.


The requirements of this particular standard take priority over those of the general standard.

A “General 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 standard.

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MEDICAL ELECTRICAL EQUIPMENT –



Part 2-49: Particular requirements for the basic

safety and essential performance of multifunction

patient monitoring equipment








201.1 Scope, object and related standards

1
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of
MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in 201.3.63, hereafter referred to as
ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital
environment as well as when used outside the hospital environment, such as in ambulances
and air transport.
ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions
outside the hospital environment, such as in ambulances and air transport, shall comply with
this particular standard. Additional standards may apply to ME EQUIPMENT for those
environments of use.
The scope of this standard is restricted to ME EQUIPMENT intended for connection to a single
PATIENT that has either two or more APPLIED PARTS or MULTIPLE FUNCTIONS on an APPLIED PART.
This standard does not specify requirements for individual monitoring functions such as ECG,
invasive pressure and pulse oximetry. The particular standards related to these physiological
parameters specify requirements from the perspective of stand-alone ME EQUIPMENT. This
particular standard addresses the differences related to MULTIFUNCTION PATIENT MONITORING
EQUIPMENT, since such equipment has a broader INTENDED USE than this stand-alone
ME EQUIPMENT.
201.1.2 Object
Replacement:

The object of this particular standard is to establish BASIC SAFETY and
ESSENTIAL PERFORMANCE requirements for MULTIFUNCTION PATIENT MONITORING EQUIPMENT as
defined in 201.3.63.
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.
—————————
1
 The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.

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60601-2-49  IEC:2011 – 9 –


IEC 60601-1-2 and IEC 60601-1-8 apply as modified in Clauses 202 and 208 respectively.

IEC 60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1

series apply as published.


201.1.4 Particular standards


Replacement:


In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL

PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this particular standard addresses the
content of Clause 1 of the general standard) or applicable collateral standard with the prefix
“20x”, where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in
this particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.

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201.2 Normative references


Clause 2 of the general standard applies, except as follows.


Replacement:


IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Collateral standard: Electromagnetic compatibility –

Requirements and tests


IEC 60601-1-8:2006, 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.
ISO 15223-1:2007, Medical devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General requirements
Addition:
IEC 60601-2-2:2009, 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
2
IEC 60601-2-27:___ , Medical electrical equipment – Part 2-27, Particular requirements for
the basic safety and essential performance of electrocardiographic monitoring equipment
3
IEC 60601-2-34:___ , 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
NOTE An index of defined terms is found beginning on page 50.
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005
apply, except as follows:
Replacement:
201.3.63
MULTIFUNCTION PATIENT MONITORING EQUIPMENT

ME EQUIPMENT
modular or pre-configured device whose primary intended use is patient monitoring provided
with not more than one connection to a particular SUPPLY MAINS, including more than one
PHYSIOLOGICAL MONITORING UNIT designed to acquire physiological signals from a single
PATIENT and to process those signals for display purposes and to generate ALARM SIGNALS
Additional definitions:
201.3.201
MULTIPLE FUNCTION
measurement of more than one physiological function on one APPLIED PART
—————————
2
Third edition, to be published.
3
Third edition, to be published.

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60601-2-49  IEC:2011 – 11 –


201.3.202

PART LEAKAGE CURRENT

current flowing from all PATIENT CONNECTION of one SINGLE FUNCTION of an APPLIED PART

through the PATIENT to the remaining PATIENT CONNECTION(S) of all other SINGLE FUNCTION(S) of

that same APPLIED PART under NORMAL CONDITIONS and not intended to produce a

physiological effect


201.3.203

PHYSIOLOGICAL MONITORING UNIT

part of the ME EQUIPMENT whose purpose is to collect information relating to (a) physiological
function(s) and to process it for monitoring and possibly also diagnostic purposes


201.3.204
SINGLE FUNCTION
measurement of one physiological function on one APPLIED PART
NOTE Examples of physiological functions are body temperature, ECG, ECG/impedance respiration, invasive and
non-invasive blood pressure etc.
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements for MULTIFUNCTION PATIENT MONITORING
are found in subclauses listed in Table 201.101.
EQUIPMENT
Table 201.101 – ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Defibrillator protection 201.8.5.5.1
Electrosurgery interference 202.6.2.101
Delays to or from a DISTRIBUTED ALARM SYSTEM 208.6.4.2

201.4.5 * Equivalent safety for ME EQUIPMENT or ME SYSTEMS
Addition:

When several particular standards simultaneously apply to MULTI-FUNCTION PATIENT
MONITORING EQUIPMENT, all relevant requirements from those standards shall be applied. If
requirements from particular standards are in conflict, the RISK MANAGEMENT PROCESS shall be
used to identify which standard
...