IEC TR 60601-4-4:2017

IEC TR 60601-4-4 ®
Edition 1.0 2017-08
TECHNICAL
REPORT
Medical electrical equipment –
Part 4-4: Guidance and interpretation – Guidance for writers of particular
standards when creating alarm system-related requirements
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IEC TR 60601-4-4 ®
Edition 1.0 2017-08
TECHNICAL
REPORT
Medical electrical equipment –

Part 4-4: Guidance and interpretation – Guidance for writers of particular

standards when creating alarm system-related requirements

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-4685-6

– 2 – IEC TR 60601-4-4:2017 © IEC 2017
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope and object . 7
1.1 Scope . 7
1.2 Object . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Overview . 8
5 Recommendations . 9
5.1 Prohibiting the use of the untimed ACKNOWLEDGED ALARM SIGNAL inactivation
state . 9
5.1.1 General . 9
5.1.2 Recommended text to prohibit the use of the untimed ACKNOWLEDGED
ALARM SIGNAL inactivation state . 9
5.2 Requiring an ALARM CONDITION and its priority . 10
5.2.1 General . 10
5.2.2 Recommended text to require an ALARM CONDITION and its priority . 10
5.2.3 Example 1 for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT . 10
5.2.4 Example 2 for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT . 10
5.2.5 Example for PULSE OXIMETER EQUIPMENT . 11
5.3 Requiring a maximum pause duration, option 1 . 11
5.3.1 General . 11
5.3.2 Recommended text to require a maximum pause duration, option 1 . 11
5.3.3 Example . 11
5.4 Requiring a maximum pause duration, option 2 . 11
5.4.1 General . 11
5.4.2 Recommended text to require a maximum pause duration, option 2 . 12
5.4.3 Example for a critical care VENTILATOR . 12
5.5 Requiring a restriction for the adjustment range of an ALARM LIMIT . 13
5.5.1 General . 13
5.5.2 Recommended text to restrict the adjustment range of an ALARM LIMIT,
option 1, limit the range . 13
5.5.3 Example for a RESPIRATORY GAS MONITOR (RGM) . 13
5.5.4 Recommended text to restrict the adjustment range of an ALARM LIMIT,
option 2, ensure that the range is wide enough . 14
5.5.5 Example for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT . 14
5.6 Requiring disclosure of a means for testing ALARM SIGNALS . 14
5.6.1 General . 14
5.6.2 Recommended text to require disclosure of a means of testing ALARM
SIGNALS . 14
5.6.3 Example for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT . 15
5.7 Requiring disclosure of a means for testing the ALARM SYSTEM . 15
5.7.1 General . 15
5.7.2 Recommended text to require disclosure of a means of testing the
ALARM SYSTEM . 15
5.7.3 Example for a critical care VENTILATOR . 15
5.8 Requiring REMINDER SIGNALS during ALARM SIGNAL inactivation, option 1 . 16
5.8.1 General . 16

5.8.2 Recommended text to require the generation of REMINDER SIGNALS
during ALARM SIGNAL inactivation . 16
5.8.3 Example for INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT . 16
5.9 Requiring REMINDER SIGNALS during ALARM SIGNAL inactivation, option 2 . 16
5.9.1 Recommended text to require the generation of REMINDER SIGNALS
during ALARM SIGNAL inactivation . 16
5.9.2 Example . 17
5.10 Requiring the capability for a connection to a DISTRIBUTED ALARM SYSTEM . 17
5.10.1 General . 17
5.10.2 Recommended text to require the capability for a connection to a
DISTRIBUTED ALARM SYSTEM . 17
5.10.3 Example for a VENTILATOR FOR A VENTILATOR-DEPENDENT PATIENT. 17
5.11 Requiring a maximum ALARM SIGNAL GENERATION DELAY . 18
5.11.1 General . 18
5.11.2 Recommended text to require a maximum ALARM SIGNAL GENERATION
DELAY . 18
5.11.3 Example for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT . 18
5.12 Requiring ALARM SYSTEM logging . 18
5.12.1 General . 18
5.12.2 Recommended text to require ALARM SYSTEM logging . 18
5.12.3 Example for a life-supporting homecare VENTILATOR . 19
5.13 Requiring the use of the ACKNOWLEDGED ALARM SIGNAL inactivation state . 20
5.13.1 General . 20
5.13.2 Recommended text to require the use of the ACKNOWLEDGED ALARM
SIGNAL inactivation state . 20
Bibliography . 21
Index of defined terms used in this document . 22

Table 1 – Recommendations for particular standard references to the collateral
standard IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD:2012 . 9

– 4 – IEC TR 60601-4-4:2017 © IEC 2017
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 4-4: Guidance and interpretation – Guidance for
writers of particular standards when creating
alarm system-related requirements

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
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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.
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 60601-4-4, which is a technical report, has been prepared by a Joint Working Group of
subcommittee 62A: Common aspects of electrical equipment used in medical practice, of
IEC technical committee 62: Electrical equipment in medical practice, and ISO subcommittee
SC 3: Lung ventilators and related equipment, of ISO technical committee 121: Anaesthetic
and respiratory equipment.
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62A/1186/DTR 62A/1197/RVDTR
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
A list of all parts in the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
Terms used throughout this document that have been defined in Clause 3 appear in SMALL
CAPITALS.
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 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.
A bilingual version of this publication may be issued at a later date.

– 6 – IEC TR 60601-4-4:2017 © IEC 2017
INTRODUCTION
It has become apparent in reviewing various particular standards in the IEC 60601 and
IEC 80601 or ISO 80601 series of standards that there is inconsistency in the references to
ALARM SYSTEM-related requirements. This inconsistency is especially challenging for
MANUFACTURERS whose products have multiple applicable particular standards.
This document was generated to address this problem by providing model language, with
examples, for common ALARM SYSTEM-related requirements that have been needed in existing
particular standards. It is hoped that writers of particular standards will use this model
language when ALARM SYSTEM-related requirements need to be provided in these standards.
This document contains 13 recommendations, numbered 1 to 13 (see Table 1). All these
recommendations are based upon IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012.
The numbering of clauses and subclauses of this document corresponds to that of
IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012 with the prefix “208” (e.g. 208.1 in
this document addresses the content of Clause 1 of IEC 60601-1-8:2006 and
IEC 60601-1-8:2006/AMD1:2012). Similarly, IEC 60601-1:2005 and IEC 60601-
1:2005/ AMD1:2012 are indicated with the prefix “201” (e.g. 201.4 in this document addresses
the content of Clause 4 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012). Changes to
the rationale for a clause or subclause are indicated with the prefix "Subclause"
(e.g. Subclause 208.6.8.5 indicates rationale for Subclause 208.6.8.5).
The changes to the text are specified by the use of the following words:
"Replacement" means that the clause or subclause of the reference is replaced completely by
the text of this document.
"Addition" means that the text of this document is additional to the requirements of the
reference.
"Amendment" means that the clause or subclause of the reference is amended as indicated
by the text of this document.
MEDICAL ELECTRICAL EQUIPMENT –

Part 4-4: Guidance and interpretation – Guidance for
writers of particular standards when creating
alarm system-related requirements

1 Scope and object
1.1 Scope
This document is intended to assist writers when drafting ALARM SYSTEM-related requirements
for particular standards in the IEC 60601 and IEC 80601 or ISO 80601 series of standards.
1.2 Object
The object of this document is to encourage consistent references to ALARM SYSTEM-related
requirements when introducing those requirements to particular standards. This is
accomplished by providing suggested model language, with examples, for common ALARM
SYSTEM-related requirements. Each of the recommendations is based upon text that has been
used in existing particular standards. The expectation is that this model language will be used
when ALARM SYSTEM-related requirements are needed in particular standards.
The collateral standard for ALARM SYSTEMS, IEC 60601-1-8, contains the horizontal ALARM
SYSTEM-related requirements for ME EQUIPMENT and ME SYSTEMS. The recommendations in this
document are intended to aid the writers of particular standards when referencing IEC 60601-
1-8:2006 and IEC 60601-1-8:2006/AMD1:2012.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their
content constitutes requirements of this document. For dated references, only the edition
cited applies. For undated references, the latest edition of the referenced document (including
any amendments) applies.
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1-8:2006, 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 60601-2-27:2011, 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
ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use – Part 1: Salt
test method to assess filtration performance

– 8 – IEC TR 60601-4-4:2017 © IEC 2017
ISO 80601-2-12:2011, Medical electrical equipment – Part 2-12: Particular requirements for
basic safety and essential performance of critical care ventilators
ISO 80601-2-55:2011, Medical electrical equipment – Part 2-55: Particular requirements for
the basic safety and essential performance of respiratory gas monitors
ISO 80601-2-61:2011, Medical electrical equipment – Part 2-61: Particular requirements for
basic safety and essential performance of pulse oximeter equipment
ISO 80601-2-72:2015, Medical electrical equipment – Part 2-72:Particular requirements for
basic safety and essential performance of home healthcare environment ventilators for
ventilator-dependent patients
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012,
IEC 60601-2-27:2011, IEC 60601-2-34:2011, ISO 23328-1:2003, ISO 80601-2-12:2011,
ISO 80601-2-55:2011, ISO 80601-2-61:2011 and ISO 80601-2-72:2015 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 22.
4 Overview
Table 1 provides an overview of the recommendations in this document listed in the order of
the subclauses of the collateral standard, IEC 60601-1-8:2006 and
IEC 60601-1-8:2006/AMD1:2012.
In these recommendations, text in a field with
• square brackets [ ] represents where the writers should choose an appropriate phrase.
• curly brackets { } represents a field where the choices are listed inside the brackets or
later in the text.
Table 1 – Recommendations for particular standard references to the collateral
standard IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD:2012
Recommend
Subclause of the
ation Topic Page
particular standard
number
201.7.9.2.8.101 5.6 Requiring disclosure of a means for testing ALARM SIGNALS 14
201.7.9.3.101 5.7 Requiring disclosure of a means for testing the ALARM 15
SYSTEM
208.6.6.2.101 5.5 Requiring a restriction for the adjustment range of an 13
ALARM LIMIT
208.6.8.1 5.13 Requiring the use of the ACKNOWLEDGED ALARM SIGNAL 18
inactivation state
208.6.8.1 5.1 Prohibiting the use of the untimed ACKNOWLEDGED ALARM 9
SIGNAL inactivation state
208.6.8.2 5.8 Requiring REMINDER SIGNALS, option 1 16
208.6.8.2 5.9 Requiring REMINDER SIGNALS, option 2 16
208.6.8.5 5.3 Requiring a maximum pause duration, option 1 11
208.6.8.5 5.4 Requiring a maximum pause duration, option 2 11
208.6.12 5.12 Requiring ALARM SYSTEM logging 18
a
— 5.11 Requiring a maximum ALARM SIGNAL GENERATION DELAY 17
a
— 5.2 Requiring an ALARM CONDITION and its priority 9
b
— 5.10 Requiring the capability for a connection to a DISTRIBUTED 17
ALARM SYSTEM
a
Generally placed in a particular standard subclause calling out the ALARM CONDITION.
b
Generally placed in a particular standard in subclause 201.10x.

5 Recommendations
5.1 Prohibiting the use of the untimed ACKNOWLEDGED ALARM SIGNAL inactivation state
5.1.1 General
This recommendation is applicable only for those particular standards that intend to prohibit
the use of the untimed ACKNOWLEDGED ALARM SIGNAL inactivation state.
The recommended text would typically be placed in the particular standard at 208.6.8.1.
5.1.2 Recommended text to prohibit the use of the untimed ACKNOWLEDGED ALARM
SIGNAL inactivation state
208.6.8.1 General
Amendment (delete from the first paragraph):
or indeterminate (indefinite ACKNOWLEDGED)
Amendment (add to end of the first paragraph):
ME EQUiPMENT shall not be equipped with a means for the clinical OPERATOR to initiate the
indeterminate (indefinite) ACKNOWLEDGED ALARM SIGNAL inactivation state.
Check compliance by functional testing.

– 10 – IEC TR 60601-4-4:2017 © IEC 2017
5.2 Requiring an ALARM CONDITION and its priority
5.2.1 General
This recommendation is applicable only for those particular standards that intend to require
an ALARM CONDITION and its associated priority.
The recommended text would typically be placed in the particular standard in a subclause
where the source of the ALARM CONDITION is considered (e.g. 201.12.1.xxx, 201.12.4.xxx or
208.6.1.2.xxx).
5.2.2 Recommended text to require an ALARM CONDITION and its priority
ME EQUIPMENT shall be equipped with an ALARM SYSTEM that detects an ALARM CONDITION to
indicate [describe the ALARM CONDITION here]. The [describe the ALARM CONDITION here] ALARM
CONDITION shall be at least {choose a priority from the choices below}, unless an INTELLIGENT
ALARM SYSTEM, based on additional information, determines that the [describe the ALARM
CONDITION here] ALARM CONDITION is suppressed or its priority is changed.
Choices:
• HIGH PRIORITY,
...