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.

General Information

Status
Published
Publication Date
07-Mar-2018
Current Stage
PPUB - Publication issued
Start Date
08-Mar-2018
Completion Date
08-Mar-2018
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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
IEC 80601-2-49:2018-03(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
IEC 80601-2-49:2018 © IEC 2018 – 3 –

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

---------------------- Page: 5 ----------------------
– 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

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC

Publication(s)"). 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. 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 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 IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

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assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

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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.
---------------------- Page: 6 ----------------------
IEC 80601-2-49:2018 © IEC 2018 – 5 –
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.
---------------------- Page: 7 ----------------------
– 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.
---------------------- Page: 8 ----------------------
IEC 80601-2-49:2018 © IEC 2018 – 7 –
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.

---------------------- Page: 9 ----------------------
– 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.
---------------------- Page: 10 ----------------------
IEC 80601-2-49:2018 © IEC 2018 – 9 –
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.
---------------------- Page: 11 ----------------------
– 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

---------------------- Page: 12 ----------------------
IEC 80601-2-49:2018 © IEC 2018 – 11 –
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 term
...

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