Amendment 2 - 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

Amendement 2 - Appareils électromédicaux - Partie 1-8 : Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux

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Publication Date
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IEC 60601-1-8:2006/AMD2:2020 - Amendment 2 - 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
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IEC 60601-1-8:2006/AMD2:2020 - Amendment 2 - 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
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IEC 60601-1-8
Edition 2.0 2020-07
INTERNATIONAL
STANDARD
colour
inside
AMENDMENT 2
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 60601-1-8:2006-10/AMD2:2020-07(en)
---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2020 IEC, Geneva, Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form

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---------------------- Page: 2 ----------------------
IEC 60601-1-8
Edition 2.0 2020-07
INTERNATIONAL
STANDARD
colour
inside
AMENDMENT 2
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-8631-9

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

---------------------- Page: 3 ----------------------
– 2 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
FOREWORD

This amendment has been prepared by subcommittee 62A: Common aspects of electrical

equipment used in medical practice, of IEC technical committee 62: Electrical equipment in

medical practice, and ISO subcommittee 3: Respiratory devices and related equipment used for

patient care, of ISO technical committee 121: Anaesthetic and respiratory equipment.

It is published as a double logo amendment.
The text of this amendment is based on the following documents of IEC:
FDIS Report on voting
62A/1392/FDIS 62A/1407/RVD

Full information on the voting for the approval of this amendment can be found in the report on

voting indicated in the above table. In ISO, the amendment has been approved by 15 P

members out of 15 having cast a vote.

The committee has decided that the contents of this amendment and the base 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.

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 or

ISO 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 committee that the content of this publication be

adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication 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 colour printer.

_____________
---------------------- Page: 4 ----------------------
IEC 60601-1-8:2006/AMD2:2020 – 3 –
© IEC 2020
INTRODUCTION TO AMENDMENT 2

The second edition of IEC 60601-1-8 was published in 2006 and amended in 2012. Since the

publication of IEC 60601-1-8:2006+A1:2012, the IEC Subcommittee (SC) 62A Secretariat has

been collecting issues from a variety of sources including comments from National Committees.

At the November 2015 meeting of IEC/SC 62A in Kobe, Japan, the subcommittee initiated a

process to identify high-priority issues that need to be considered in an amendment and should

not wait until the third edition of IEC 60601-1-8, which is presently targeted for publication

sometime after 2024.

Those issues selected for inclusion on the final "short list" to be addressed in Amendment 2

were those approved by a 2/3 majority of the National Committees present and voting at the

Frankfurt meeting of SC 62A. At the meeting held on 10 October 2016, 20 items were presented

to the National Committees present. All 20 items received the required 2/3 majority of the

National Committees present and voting and have been included in the "short list" for

consideration in preparing Amendment 2. All remaining issues have been placed on a "long list"

for consideration in the third edition of IEC 60601-1-8.

The "short list" of issues was documented in the design specification for Amendment 2. As

IEC 60601-1-8 was jointly developed with ISO/TC 121/SC 3, the work was assigned to

IEC/SC 62A-ISO/TC 121/SC 3 Joint Working Group (JWG) 2. JWG 2 was directed to consider

each issue described in Clause 6 of the design specification and develop an appropriate

solution for the identified problem. That final solution in this amendment can encompass any

technical solution proposed by the author of the issue or it can involve a different solution

developed by the expert group. The expert group can also have recommended that no change

to the standard was justified by the problem statement.

Because this is an amendment to IEC 60601-1-8:2006, the style in force at the time of

publication of IEC 60601-1-8 has been applied to this amendment. The style specified in

ISO/IEC Directives Part 2:2018 has only been applied when implementing the new style

guidance would not result in additional editorial changes. For example, notes to definitions are

designated as "NOTE" rather than "Note to entry" in Clause 3.

Users of this document should note that when constructing the dated references to specific

elements in a standard, such as definitions, amendments are only referenced if they modified

the text being cited. For example, if a reference is made to a definition that has not been

modified by an amendment, then the reference to the amendment is not included in the dated

reference.
---------------------- Page: 5 ----------------------
– 4 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
INTRODUCTION

Replace, in the second sentence of the existing second paragraph, "source" with "origin".

1.3.1 IEC 60601-1
Replace the first two existing dashes with the following new dashes:
– "the general standard" designates IEC 60601-1 alone, including any amendments;

– "this collateral standard" designates IEC 60601-1-8 alone, including any amendments;

2 Normative references

Replace the existing references to IEC 60601-1, IEC 61672-1 and IEC 62366-1 by the following

new references:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety

and essential performance
Amendment 1:2012
Amendment 2:2020
IEC 61672-1:2013, Electroacoustics – Sound level meters – Part 1: Specifications

IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical

devices
Amendment 1:2020
3 Terms and definitions
Replace the existing first paragraph with the following new paragraph:
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012+A2:2020, IEC 62366-1:2015+A1:2020, and the following
definitions apply.
3.17
* DISTRIBUTED ALARM SYSTEM
Replace the existing term and definition with the following new entry:
3.17
* DISTRIBUTED ALARM SYSTEM
DAS

ALARM SYSTEM that involves more than one item of equipment in a ME SYSTEM intended for delivery

of ALARM CONDITIONS with technical confirmation

NOTE 1 The parts of a DISTRIBUTED ALARM SYSTEM can be widely separated in distance.

NOTE 2 A DISTRIBUTED ALARM SYSTEM is intended to notify OPERATORS of the existence of an ALARM CONDITION.

NOTE 3 For the purposes of this document, technical confirmation means that each element of a DISTRIBUTED ALARM

SYSTEM confirms or guarantees the successful delivery of the ALARM CONDITION to the next element or appropriate

TECHNICAL ALARM CONDITIONS are created as described in 6.11.2.2.1.
3.20
FALSE NEGATIVE ALARM CONDITION

Replace, in the existing note, "the equipment itself" with "the ALARM SYSTEM itself".

---------------------- Page: 6 ----------------------
IEC 60601-1-8:2006/AMD2:2020 – 5 –
© IEC 2020
3.22
HIGH PRIORITY
Replace the existing note with the following new notes:

NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.

NOTE 2 Immediate implies the interruption of current workflow is expected [59], [60].

3.23
*INFORMAL SIGNAL
Add, after the existing Example 3, the following new note:
NOTE An ADVISORY is a type of INFORMATION SIGNAL.
3.25
INTERBURST INTERVAL

Replace, in the existing parenthetical, "Figure 1" with "Figure 1 and Figure G.1".

Add the following new note:

NOTE For the purposes of this document, when an AUDITORY ICON is used, the INTERBURST INTERVAL begins at the

end of the AUDITORY ICON.
3.27
LOW PRIORITY
Replace the existing term, definition and note with the following new entry:
3.27
LOW PRIORITY
indicating that OPERATOR awareness is required and future action might be needed

NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.

NOTE 2 Awareness implies the planning of future workflow is expected [59], [60].
3.28
MEDIUM PRIORITY
Replace the existing note with the following new notes:

NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.

NOTE 2 Prompt implies the re-planning of current workflow is expected [59], [60].

3.37
* ACKNOWLEDGED

Replace the existing term, definition and notes, added by Amendment 1, with the following new

entry:
3.37
* ACKNOWLEDGED

state of an ALARM SYSTEM initiated by OPERATOR action, where the auditory ALARM SIGNAL

associated with a currently active ALARM CONDITION is inactivated until the ALARM CONDITION no

longer exists or until a predetermined time interval has elapsed

NOTE ACKNOWLEDGED only affects ALARM SIGNALS that are active at the time of the OPERATOR action.

Add, after 3.37, the following new terms and definitions:
---------------------- Page: 7 ----------------------
– 6 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
3.38
* ADVISORY
ADVISORY SIGNAL

INFORMATION SIGNAL notifying the OPERATOR of a condition of the PATIENT or ME EQUIPMENT

providing contextual awareness that is intended to improve the clinical workflow or

PATIENT condition, the awareness not being intended as a means of RISK
understanding of the
CONTROL

NOTE 1 A notification that a lab result is available, where the lab result requires immediate clinical action is not an

ADVISORY. It is an ALARM CONDITION.

NOTE 2 A signal associated with an ADVISORY, which is an INFORMATION SIGNAL, is required by this document to be

designed so that an OPERATOR does not confuse it with an ALARM SIGNAL. See 6.3.2.2.2 and 6.3.3.2.

EXAMPLE 1 A notification that it is time to draw the next blood sample.

EXAMPLE 2 A battery status notification that replacement will be needed in a day.

EXAMPLE 3 A notification that it is time to bathe the PATIENT.

EXAMPLE 4 A notification that a lab result is available, where the lab results are normal.

3.39
ALARM FATIGUE

situation wherein the presence of frequent ALARM SIGNALS desensitizes an OPERATOR to an

ALARM SIGNAL

NOTE 1 A desensitized OPERATOR can fail to perceive, recognize or act on an ALARM SIGNAL.

NOTE 2 The response of a desensitized OPERATOR can be inadequate, delayed or non-existent.

NOTE 3 ALARM FLOOD can cause ALARM FATIGUE.
3.40
ALARM FLOOD

situation wherein OPERATORS receive more ALARM SIGNALS in a time period than they can

manage appropriately
NOTE See [56], [57].
3.41
* ALERT

synonym for the combination of PHYSIOLOGICAL ALARM CONDITIONS, TECHNICAL ALARM CONDITIONS

and ADVISORIES

[SOURCE: ISO/IEEE 11073-10201:2020 [76], 3.3, modified – Replaced "alarms" with "ALARM

CONDITIONS", "equipment-user advisory signals" with "ADVISORIES" and deleted "patient

related".]
3.42
AUDITORY ICON
sound that creates a strong semantic link to the category it represents

NOTE 1 An AUDITORY ICON is typically a real-world sound or mimics a real-world sound.

NOTE 2 An AUDITORY ICON can aid in locating the COMMUNICATOR and the SOURCE type.

3.43
AUDITORY POINTER

sound that attracts attention, denotes the priority and aids in localization of the COMMUNICATOR

---------------------- Page: 8 ----------------------
IEC 60601-1-8:2006/AMD2:2020 – 7 –
© IEC 2020
3.44
* CLINICALLY ACTIONABLE

type of ALARM CONDITION for which a panel of experts would agree that OPERATOR action is

necessary to prevent HARM within the timeframe implied by the priority communicated by the

ALARM SYSTEM

NOTE 1 An OPERATOR action can include assessment of a PATIENT or the changing of ALARM LIMITS when they are

inappropriately set for the state of the PATIENT.

NOTE 2 A LOW PRIORITY ALARM CONDITION, which requires action within the timeframe of a MEDIUM PRIORITY or HIGH

PRIORITY timeframe, is considered CLINICALLY ACTIONABLE. A HIGH PRIORITY ALARM CONDITION, which requires action

within the timeframe of a LOW PRIORITY or MEDIUM PRIORITY timeframe, is considered CLINICALLY NONACTIONABLE. In

both cases, the ALARM CONDITION priority was improperly assigned.

NOTE 3 A FALSE POSITIVE ALARM CONDITION is never considered CLINICALLY ACTIONABLE even though an unrelated

OPERATOR action might be required to prevent a future FALSE POSITIVE ALARM CONDITION.

NOTE 4 A CLINICALLY ACTIONABLE ALARM CONDITION is generally considered useful by the OPERATOR.

3.45
* CLINICALLY NONACTIONABLE

type of ALARM CONDITION for which a panel of experts would agree that OPERATOR action is not

expected within a timeframe equal to or shorter than the timeframe implied by its priority

NOTE 1 A LOW PRIORITY ALARM CONDITION, which requires action within the timeframe of a MEDIUM PRIORITY or HIGH

PRIORITY timeframe, is considered CLINICALLY ACTIONABLE. A HIGH PRIORITY ALARM CONDITION, which requires action

within the timeframe of a LOW PRIORITY or MEDIUM PRIORITY timeframe, is considered CLINICALLY NONACTIONABLE. In

both cases, the ALARM CONDITION priority was improperly assigned.

NOTE 2 CLINICALLY NONACTIONABLE ALARM CONDITIONS are considered detrimental to OPERATOR performance and

PATIENT safety.

NOTE 3 ALARM SIGNALS for an ALARM CONDITION of which the OPERATOR is already aware are considered CLINICALLY

NONACTIONABLE.
3.46
COMMUNICATOR
COM
ANNUNCIATOR

function of the ALARM SYSTEM that generates ALARM SIGNALS to notify an OPERATOR (e.g. to the

presence of an ALARM CONDITION)
NOTE 1 A COMMUNICATOR can receive an OPERATOR response.
NOTE 2 An OPERATOR response is not limited to direct OPERATOR action.
NOTE 3 See Figure 2.
3.47
DISTRIBUTED ALARM SYSTEM WITH OPERATOR CONFIRMATION
CDAS

DISTRIBUTED ALARM SYSTEM that includes the capability to receive an OPERATOR response

3.48
* DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS
DIS

system that involves more than one item of equipment in a ME SYSTEM intended to provide

information about ALARM CONDITIONS but does not guarantee delivery of that information

NOTE 1 A DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS is not intended to notify OPERATORS of the

existence of an ALARM CONDITION as a RISK CONTROL measure. A DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM

CONDITIONS is intended to provide information about an ALARM CONDITION while the OPERATOR is aware of the

existence of the ALARM CONDITION by an ALARM SYSTEM.

NOTE 2 A DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS is not intended for confirmed delivery of

ALARM CONDITIONS.
---------------------- Page: 9 ----------------------
– 8 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
3.49
INTEGRATOR
INT
ALARM MANAGER

function of the ALARM SYSTEM that distributes ALARM CONDITIONS, combines ALARM CONDITIONS

SOURCES or handles the communication between those SOURCES and COMMUNICATORS
from

NOTE 1 An INTEGRATOR can direct or redirect an ALARM CONDITION to another COMMUNICATOR and hence OPERATOR.

NOTE 2 An INTEGRATOR can send the acceptance of responsibility from a COMMUNICATOR to a SOURCE.

NOTE 3 See Figure 2.
3.50
* NUISANCE ALARM SIGNAL

ALARM SIGNAL for which a panel of experts would agree that the HARM associated with the ALARM

SIGNAL is greater than the benefit associated with action resulting from the ALARM SIGNAL

NOTE 1 A NUISANCE ALARM SIGNAL contributes to ALARM FATIGUE.
NOTE 2 A NUISANCE ALARM SIGNAL can arise from a FALSE POSITIVE ALARM CONDITION.

NOTE 3 A NUISANCE ALARM SIGNAL can arise from a CLINICALLY NONACTIONABLE ALARM CONDITION.

NOTE 4 A NUISANCE ALARM SIGNAL can cause an inappropriate OPERATOR action.
EXAMPLE Causing the OPERATOR to set ALARM LIMITS to inappropriate settings.

NOTE 5 An ALARM SIGNAL that unnecessarily irritates or startles the PATIENT or OPERATOR can be a NUISANCE ALARM

SIGNAL.
3.51
REDIRECTION
INTEGRATOR provides a response hierarchy for directing an ALARM CONDITION
means by which an
to a COMMUNICATOR or transfers an ALARM CONDITION to another COMMUNICATOR
NOTE See Figure 2.
3.52
RESPONSIBILITY ACCEPTED

state created by an OPERATOR response accepting ownership for addressing an ALARM

CONDITION

NOTE 1 A RESPONSIBILITY ACCEPTED can be used to initiate an ALARM SIGNAL inactivation state.

NOTE 2 See Figure 2.
3.53
RESPONSIBILITY REJECTED

state created by an OPERATOR response rejecting ownership for addressing an ALARM CONDITION

NOTE 1 A RESPONSIBILITY REJECTED can be used to initiate an ESCALATION or REDIRECTION.

NOTE 2 See Figure 2.
3.54
RESPONSIBILITY UNDEFINED

state, automatically initiated when neither a RESPONSIBILITY ACCEPTED nor RESPONSIBILITY

REJECTED is received within a specified period, which indicates that an OPERATOR is not

responding

NOTE 1 RESPONSIBILITY UNDEFINED is not used as an indication that the COMMUNICATOR and INTEGRATOR cannot

communicate.
NOTE 2 See Figure 2.
---------------------- Page: 10 ----------------------
IEC 60601-1-8:2006/AMD2:2020 – 9 –
© IEC 2020
3.55
SOURCE
SRC
function that has the capability to initiate an ALARM CONDITION
NOTE 1 The SOURCE transfers the ALARM CONDITION to the INTEGRATOR.
NOTE 2 See Figure 2.
3.56
TRUE NEGATIVE ALARM CONDITION

absence of an ALARM CONDITION when no valid triggering event has occurred in the PATIENT, the

equipment or the ALARM SYSTEM
3.57
TRUE POSITIVE ALARM CONDITION

presence of an ALARM CONDITION when a valid triggering event has occurred in the PATIENT, the

equipment or the ALARM SYSTEM
6.2 * Disclosures for INTELLIGENT ALARM SYSTEM
Replace the existing list item e) with the following new item:

e) changes the characteristics of the generated ALARM SIGNALS (for example, volume, pitch,

tempo, urgency, AUDITORY ICON category).
6.3.1 General

Replace, in the first sentence of the existing first paragraph, "ALARM SIGNALS" with "ALARM

SIGNALS by a COMMUNICATOR".
6.3.2.2.2 1 m (OPERATOR’s POSITION) visual ALARM SIGNALS and INFORMATION SIGNALS

Replace, in the existing Note 3, modified by Amendment 1, "IEC 62366" with "IEC 62366-1".

Replace the existing Note 5, added by Amendment 1, with the following new note:

NOTE 5 It is recognized that visual INFORMATION SIGNALS and visual ALARM SIGNALS can sometimes contain identical

or similar information. When they are intended to convey different meanings, care needs to be taken to ensure that

visual ALARM SIGNALS cannot be confused with visual INFORMATION SIGNALS.
6.3.3.1 * Characteristics of auditory ALARM SIGNALS

Replace, in the existing first paragraph, modified by Amendment 1, the first sentence with:

If a COMMUNICATOR of an ALARM SYSTEM is provided with auditory ALARM SIGNALS:
Replace the existing list item b) to d), modified by Amendment 1, with:

b) of HIGH PRIORITY, the HIGH PRIORITY auditory ALARM SIGNALS of that COMMUNICATOR shall

convey a higher level of urgency than the MEDIUM or LOW PRIORITY auditory ALARM SIGNALS of

that ALARM SIGNAL set as well as a higher level of urgency than any auditory INFORMATION

SIGNAL

c) of MEDIUM PRIORITY, the MEDIUM PRIORITY auditory ALARM SIGNALS of that COMMUNICATOR shall

convey a higher level of urgency than the LOW PRIORITY auditory ALARM SIGNALS of that ALARM

SIGNAL set as well as a higher level of urgency than any auditory INFORMATION SIGNAL;

d) the COMMUNICATOR shall have at least one set of ALARM SIGNALS that:
1) complies with Annex G; or
---------------------- Page: 11 ----------------------
– 10 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
i) * A COMMUNICATOR with means to provide more than one set of auditory ALARM
SIGNALS should be equipped with at least one set of auditory ALARM SIGNALS that
complies with Annex G.
ALARM

2) * is generated by means of different technology (e.g. voice synthesizing of verbal

SIGNALS) and is VALIDATED (e.g. by clinical or simulated clinical USABILITY testing); or

3) * meets the requirements of Table 3 and Table 4.

Replace, in the existing Note 2, modified by Amendment 1, "IEC 62366" with "IEC 62366-1".

Delete the existing paragraph following Note 2.

Replace, in the third sentence of the existing compliance check, modified by Amendment 1,

"Verify" with "Confirm".
Delete t from the compliance check modified by Amendment 1.

Replace the existing last sentence of the compliance check, modified by Amendment 1, with

the following new sentence:

When the sound files of Annex G are utilized, only testing of t is required and testing of the

acoustic signal is permitted.

Replace the existing last paragraph, added by Amendment 1, with the following new paragraph:

Amongst the required frequency components with the largest sound pressure levels,

acoustically confirm the presence of at least one frequency component in range of 150 Hz to

1 000 Hz and at least the required components in the range of 150 Hz to 4 000 Hz in the auditory

ALARM SIGNAL at 1 m or the intended OPERATOR's POSITION. Only the AUDITORY POINTERS need

be tested when evaluating the ALARM SIGNALS of Annex G.
Table 3 – * Characteristics of the BURST of auditory ALARM SIGNALS

Replace, in the paragraph at the bottom of the table starting with "Where", modified by

Amendment 1, the third line with the following new text:
the variation of t , x and y within a BURST shall not exceed ± 20 %, and
Replace, in the existing table footnote c, "source" with "origin".
---------------------- Page: 12 ----------------------
IEC 60601-1-8:2006/AMD2:2020 – 11 –
© IEC 2020
Table 4 – * Characteristics of the PULSE of auditory ALARM SIGNALS

Replace the existing Table 4, modified by Amendment 1, with the following new table:

Characteristic Value

Frequency component in the range of 150 Hz to At least one that is among the four frequency

1 000 Hz components with the largest sound pressure level
Number of peaks in the frequency At least four peaks in the frequency domain
range of 150 Hz to 4 000Hz
Effective PULSE duration (t ) (see Figure 1)
75 ms to 200 ms
HIGH PRIORITY
125 ms to 250 ms
MEDIUM and LOW PRIORITY
RISE TIME (t ) (see Figure 1)
FALL TIME (t ) (see Figure 1)

Within the frequency range of 150 Hz to 4 000 Hz, the relative sound pressure levels of the four frequency

components with the largest sound pressure levels should be within 15 dB of each other.

NOTE Care is needed to ensure that the MEDIUM PRIORITY ALARM SIGNAL cannot be confused with the audible

emergency evacuation signal specified in ISO 8201:2017 [30].
The RISE TIME should not be so short as to create mechanical speaker noise.
The FALL TIME should be short enough to ensure that the PULSES do not overlap.
Figure 1 – Illustration of temporal characteristics of auditory ALARM SIGNALS
Replace, in the existing note, the word "NOTE" with "NOTE 1".
Add, after the existing note, the following new note:
NOTE 2 See Figure G.1 and Figure G.2 for additional information.

6.3.3.2 * Volume and characteristics of auditory ALARM SIGNALS and INFORMATION SIGNALS

Replace the existing first paragraph, modified by Amendment 1, with the following new

paragraph:

The auditory HIGH PRIORITY and MEDIUM PRIORITY ALARM SIGNAL sound pressure level range and

measurement radius, measured in accordance with the method of this subclause, shall be

ACCOMPANYING DOCUMENTS.
disclosed in the

Replace the existing list items c) to k), added by Amendment 1, with the following new items:

COMMUNICATOR on the floor and use a microphone of
c) Place the equipment containing the

the sound level meter complying with the requirements of type 1 instruments specified in

IEC 61672-1:2013, measure the sound pressure levels at least at positions 1, 2, 3, 4, 5, 6,

7, 8, 9 and 10, as specified in Figure B.1 and Table B.1 of ISO 3744:2010, in a hemisphere

with a radius of 1 m from the geometric centre of the COMMUNICATOR. For a large

COMMUNICATOR, where d , as calculated in Figure 1 a) of ISO 3744:2010, is greater than

0,5 m, utilize a radius such that the distance from the surface of the COMMUNICATOR to the

hemisphere is at least 0,5 m everywhere, extended to the next higher value in the series

1,5 m, 2 m, 2,5 m, 3 m, 3,5 m, 4 m.

d) Measure the maximum time-weighted sound pressure level using frequency weighting A and

the time weighting F of the sound level meter (i.e. L ).
AFmax

e) For ALARM SIGNALS utilizing AUDITORY POINTERS complying with Annex G, confirm that the

drive signal of the audio transducer utilizing an oscilloscope or other suitable instrument is

not clipped.
---------------------- Page: 13 ----------------------
– 12 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020

f) Calculate the A-weighted sound pressure level averaged over the measurement surface

according to 8.2.2 of ISO 3744:2010.

g) If the ALARM SYSTEM is provided with a MEDIUM PRIORITY ALARM CONDITION, simulate a MEDIUM

and repeat c) to f).
PRIORITY ALARM CONDITION

h) If the ALARM SYSTEM is provided with a LOW PRIORITY ALARM CONDITION, simulate a LOW

PRIORITY ALARM CONDITION and repeat c) to f).

i) Set the ALARM SIGNAL sound pressure level (volume level) to its minimum setting.

j) Repeat b) to h).

k) Confirm that the criteria for background noise, including any INFORMATION SIGNALS, specified

in 4.2 of ISO 3744:2010 are fulfilled.

l) Confirm that the measured sound pressure level range is in compliance with the values

ACCOMPANYING DOCUMENTS.
indicated in the
6.4.2 * Delays to or from a DISTRIBUTED ALARM SYSTEM

Replace the existing title and entire subclause 6.4.2, modified by Amendment 1, with the

following new text:

6.4.2 * Delays to or from a DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS (DIS)

or a DISTRIBUTED ALARM SYSTEM (DAS)

If an ALARM SYSTEM is provided with a means to send or receive ALARM CONDITIONS in a DIS or

DAS:
ALARM CONDITION to the point that the representation of
a) the delay time from the onset of the

the ALARM CONDITION leaves the SIGNAL INPUT/OUTPUT PART shall be disclosed in the

instructions for use; and

b) the maximum ALARM SIGNAL GENERATION DELAY of the COMMUNICATOR, including the method

ALARM SIGNAL GENERATION DELAY, or the time to determine
used to determine the maximum

the generation of the TECHNICAL ALARM CONDITION (see 6.11.2.2.1 b)) shall be disclosed in

the instructions for use.
The following methods may be used to determine the ALARM SIGNAL GENERATION DELAY
contribution fo
...

IEC 60601-1-8
Edition 2.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
AMENDMENT 2
AMENDEMENT 2
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
Appareils électromédicaux –
Partie 1-8: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: exigences générales, essais et guide pour les
systèmes d'alarme des appareils et des systèmes électromédicaux
IEC 60601-1-8:2006-10/AMD2:2020-07(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 60601-1-8
Edition 2.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
A MENDMENT 2
AM ENDEMENT 2
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
Appareils électromédicaux –
Partie 1-8: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: exigences générales, essais et guide pour les
systèmes d'alarme des appareils et des systèmes électromédicaux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-1014-3

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 60601-1-8:2006/AMD2:2020
© IEC 2020
FOREWORD

This amendment has been prepared by subcommittee 62A: Common aspects of electrical

equipment used in medical practice, of IEC technical committee 62: Electrical equipment in

medical practice, and ISO subcommittee 3: Respiratory devices and related equipment used for

patient care, of ISO technical committee 121: Anaesthetic and respiratory equipment.

It is published as a double logo amendment.
The text of this amendment is based on the following documents of IEC:
FDIS Report on voting
62A/1392/FDIS 62A/1407/RVD

Full information on the voting for the approval of this amendment can be found in the report on

voting indicated in the above table. In ISO, the amendment has been approved by 15 P

members out of 15 having cast a vote.

The committee has decided that the contents of this amendment and the base 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.

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 or

ISO 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 committee that the content of this publication be

adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication 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 colour printer.

_____________
---------------------- Page: 4 ----------------------
IEC 60601-1-8:2006/AMD2:2020 – 3 –
© IEC 2020
INTRODUCTION TO AMENDMENT 2

The second edition of IEC 60601-1-8 was published in 2006 and amended in 2012. Since the

publication of IEC 60601-1-8:2006+A1:2012, the IEC Subcommittee (SC) 62A Secretariat has

been collecting issues from a variety of sources including comments from National Committees.

At the November 2015 meeting of IEC/SC 62A in Kobe, Japan, the subcommittee initiated a

process to identify high-priority issues that need to be considered in an amendment and should

not wait until the third edition of IEC 60601-1-8, which is presently targeted for publication

sometime after 2024.

Those issues selected for inclusion on the final "short list" to be addressed in Amendment 2

were those approved by a 2/3 majority of the National Committees present and voting at the

Frankfurt meeting of SC 62A. At the meeting held on 10 October 2016, 20 items were presented

to the National Committees present. All 20 items received the required 2/3 majority of the

National Committees present and voting and have been included in the "short list" for

consideration in preparing Amendment 2. All remaining issues have been placed on a "long list"

for consideration in the third edition of IEC 60601-1-8.

The "short list" of issues was documented in the design specification for Amendment 2. As

IEC 60601-1-8 was jointly developed with ISO/TC 121/SC 3, the work was assigned to

IEC/SC 62A-ISO/TC 121/SC 3 Joint Working Group (JWG) 2. JWG 2 was directed to consider

each issue described in Clause 6 of the design specification and develop an appropriate

solution for the identified problem. That final solution in this amendment can encompass any

technical solution proposed by the author of the issue or it can involve a different solution

developed by the expert group. The expert group can also have recommended that no change

to the standard was justified by the problem statement.

Because this is an amendment to IEC 60601-1-8:2006, the style in force at the time of

publication of IEC 60601-1-8 has been applied to this amendment. The style specified in

ISO/IEC Directives Part 2:2018 has only been applied when implementing the new style

guidance would not result in additional editorial changes. For example, notes to definitions are

designated as "NOTE" rather than "Note to entry" in Clause 3.

Users of this document should note that when constructing the dated references to specific

elements in a standard, such as definitions, amendments are only referenced if they modified

the text being cited. For example, if a reference is made to a definition that has not been

modified by an amendment, then the reference to the amendment is not included in the dated

reference.
---------------------- Page: 5 ----------------------
– 4 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
INTRODUCTION

Replace, in the second sentence of the existing second paragraph, "source" with "origin".

1.3.1 IEC 60601-1
Replace the first two existing dashes with the following new dashes:
– "the general standard" designates IEC 60601-1 alone, including any amendments;

– "this collateral standard" designates IEC 60601-1-8 alone, including any amendments;

2 Normative references

Replace the existing references to IEC 60601-1, IEC 61672-1 and IEC 62366-1 by the following

new references:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety

and essential performance
Amendment 1:2012
Amendment 2:2020
IEC 61672-1:2013, Electroacoustics – Sound level meters – Part 1: Specifications

IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical

devices
Amendment 1:2020
3 Terms and definitions
Replace the existing first paragraph with the following new paragraph:
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012+A2:2020, IEC 62366-1:2015+A1:2020, and the following
definitions apply.
3.17
* DISTRIBUTED ALARM SYSTEM
Replace the existing term and definition with the following new entry:
3.17
* DISTRIBUTED ALARM SYSTEM
DAS

ALARM SYSTEM that involves more than one item of equipment in a ME SYSTEM intended for delivery

of ALARM CONDITIONS with technical confirmation

NOTE 1 The parts of a DISTRIBUTED ALARM SYSTEM can be widely separated in distance.

NOTE 2 A DISTRIBUTED ALARM SYSTEM is intended to notify OPERATORS of the existence of an ALARM CONDITION.

NOTE 3 For the purposes of this document, technical confirmation means that each element of a DISTRIBUTED ALARM

SYSTEM confirms or guarantees the successful delivery of the ALARM CONDITION to the next element or appropriate

TECHNICAL ALARM CONDITIONS are created as described in 6.11.2.2.1.
3.20
FALSE NEGATIVE ALARM CONDITION

Replace, in the existing note, "the equipment itself" with "the ALARM SYSTEM itself".

---------------------- Page: 6 ----------------------
IEC 60601-1-8:2006/AMD2:2020 – 5 –
© IEC 2020
3.22
HIGH PRIORITY
Replace the existing note with the following new notes:

NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.

NOTE 2 Immediate implies the interruption of current workflow is expected [59], [60].

3.23
*INFORMAL SIGNAL
Add, after the existing Example 3, the following new note:
NOTE An ADVISORY is a type of INFORMATION SIGNAL.
3.25
INTERBURST INTERVAL

Replace, in the existing parenthetical, "Figure 1" with "Figure 1 and Figure G.1".

Add the following new note:

NOTE For the purposes of this document, when an AUDITORY ICON is used, the INTERBURST INTERVAL begins at the

end of the AUDITORY ICON.
3.27
LOW PRIORITY
Replace the existing term, definition and note with the following new entry:
3.27
LOW PRIORITY
indicating that OPERATOR awareness is required and future action might be needed

NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.

NOTE 2 Awareness implies the planning of future workflow is expected [59], [60].
3.28
MEDIUM PRIORITY
Replace the existing note with the following new notes:

NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.

NOTE 2 Prompt implies the re-planning of current workflow is expected [59], [60].

3.37
* ACKNOWLEDGED

Replace the existing term, definition and notes, added by Amendment 1, with the following new

entry:
3.37
* ACKNOWLEDGED

state of an ALARM SYSTEM initiated by OPERATOR action, where the auditory ALARM SIGNAL

associated with a currently active ALARM CONDITION is inactivated until the ALARM CONDITION no

longer exists or until a predetermined time interval has elapsed

NOTE ACKNOWLEDGED only affects ALARM SIGNALS that are active at the time of the OPERATOR action.

Add, after 3.37, the following new terms and definitions:
---------------------- Page: 7 ----------------------
– 6 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
3.38
* ADVISORY
ADVISORY SIGNAL

INFORMATION SIGNAL notifying the OPERATOR of a condition of the PATIENT or ME EQUIPMENT

providing contextual awareness that is intended to improve the clinical workflow or

PATIENT condition, the awareness not being intended as a means of RISK
understanding of the
CONTROL

NOTE 1 A notification that a lab result is available, where the lab result requires immediate clinical action is not an

ADVISORY. It is an ALARM CONDITION.

NOTE 2 A signal associated with an ADVISORY, which is an INFORMATION SIGNAL, is required by this document to be

designed so that an OPERATOR does not confuse it with an ALARM SIGNAL. See 6.3.2.2.2 and 6.3.3.2.

EXAMPLE 1 A notification that it is time to draw the next blood sample.

EXAMPLE 2 A battery status notification that replacement will be needed in a day.

EXAMPLE 3 A notification that it is time to bathe the PATIENT.

EXAMPLE 4 A notification that a lab result is available, where the lab results are normal.

3.39
ALARM FATIGUE

situation wherein the presence of frequent ALARM SIGNALS desensitizes an OPERATOR to an

ALARM SIGNAL

NOTE 1 A desensitized OPERATOR can fail to perceive, recognize or act on an ALARM SIGNAL.

NOTE 2 The response of a desensitized OPERATOR can be inadequate, delayed or non-existent.

NOTE 3 ALARM FLOOD can cause ALARM FATIGUE.
3.40
ALARM FLOOD

situation wherein OPERATORS receive more ALARM SIGNALS in a time period than they can

manage appropriately
NOTE See [56], [57].
3.41
* ALERT

synonym for the combination of PHYSIOLOGICAL ALARM CONDITIONS, TECHNICAL ALARM CONDITIONS

and ADVISORIES

[SOURCE: ISO/IEEE 11073-10201:2020 [76], 3.3, modified – Replaced "alarms" with "ALARM

CONDITIONS", "equipment-user advisory signals" with "ADVISORIES" and deleted "patient

related".]
3.42
AUDITORY ICON
sound that creates a strong semantic link to the category it represents

NOTE 1 An AUDITORY ICON is typically a real-world sound or mimics a real-world sound.

NOTE 2 An AUDITORY ICON can aid in locating the COMMUNICATOR and the SOURCE type.

3.43
AUDITORY POINTER

sound that attracts attention, denotes the priority and aids in localization of the COMMUNICATOR

---------------------- Page: 8 ----------------------
IEC 60601-1-8:2006/AMD2:2020 – 7 –
© IEC 2020
3.44
* CLINICALLY ACTIONABLE

type of ALARM CONDITION for which a panel of experts would agree that OPERATOR action is

necessary to prevent HARM within the timeframe implied by the priority communicated by the

ALARM SYSTEM

NOTE 1 An OPERATOR action can include assessment of a PATIENT or the changing of ALARM LIMITS when they are

inappropriately set for the state of the PATIENT.

NOTE 2 A LOW PRIORITY ALARM CONDITION, which requires action within the timeframe of a MEDIUM PRIORITY or HIGH

PRIORITY timeframe, is considered CLINICALLY ACTIONABLE. A HIGH PRIORITY ALARM CONDITION, which requires action

within the timeframe of a LOW PRIORITY or MEDIUM PRIORITY timeframe, is considered CLINICALLY NONACTIONABLE. In

both cases, the ALARM CONDITION priority was improperly assigned.

NOTE 3 A FALSE POSITIVE ALARM CONDITION is never considered CLINICALLY ACTIONABLE even though an unrelated

OPERATOR action might be required to prevent a future FALSE POSITIVE ALARM CONDITION.

NOTE 4 A CLINICALLY ACTIONABLE ALARM CONDITION is generally considered useful by the OPERATOR.

3.45
* CLINICALLY NONACTIONABLE

type of ALARM CONDITION for which a panel of experts would agree that OPERATOR action is not

expected within a timeframe equal to or shorter than the timeframe implied by its priority

NOTE 1 A LOW PRIORITY ALARM CONDITION, which requires action within the timeframe of a MEDIUM PRIORITY or HIGH

PRIORITY timeframe, is considered CLINICALLY ACTIONABLE. A HIGH PRIORITY ALARM CONDITION, which requires action

within the timeframe of a LOW PRIORITY or MEDIUM PRIORITY timeframe, is considered CLINICALLY NONACTIONABLE. In

both cases, the ALARM CONDITION priority was improperly assigned.

NOTE 2 CLINICALLY NONACTIONABLE ALARM CONDITIONS are considered detrimental to OPERATOR performance and

PATIENT safety.

NOTE 3 ALARM SIGNALS for an ALARM CONDITION of which the OPERATOR is already aware are considered CLINICALLY

NONACTIONABLE.
3.46
COMMUNICATOR
COM
ANNUNCIATOR

function of the ALARM SYSTEM that generates ALARM SIGNALS to notify an OPERATOR (e.g. to the

presence of an ALARM CONDITION)
NOTE 1 A COMMUNICATOR can receive an OPERATOR response.
NOTE 2 An OPERATOR response is not limited to direct OPERATOR action.
NOTE 3 See Figure 2.
3.47
DISTRIBUTED ALARM SYSTEM WITH OPERATOR CONFIRMATION
CDAS

DISTRIBUTED ALARM SYSTEM that includes the capability to receive an OPERATOR response

3.48
* DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS
DIS

system that involves more than one item of equipment in a ME SYSTEM intended to provide

information about ALARM CONDITIONS but does not guarantee delivery of that information

NOTE 1 A DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS is not intended to notify OPERATORS of the

existence of an ALARM CONDITION as a RISK CONTROL measure. A DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM

CONDITIONS is intended to provide information about an ALARM CONDITION while the OPERATOR is aware of the

existence of the ALARM CONDITION by an ALARM SYSTEM.

NOTE 2 A DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS is not intended for confirmed delivery of

ALARM CONDITIONS.
---------------------- Page: 9 ----------------------
– 8 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
3.49
INTEGRATOR
INT
ALARM MANAGER

function of the ALARM SYSTEM that distributes ALARM CONDITIONS, combines ALARM CONDITIONS

SOURCES or handles the communication between those SOURCES and COMMUNICATORS
from

NOTE 1 An INTEGRATOR can direct or redirect an ALARM CONDITION to another COMMUNICATOR and hence OPERATOR.

NOTE 2 An INTEGRATOR can send the acceptance of responsibility from a COMMUNICATOR to a SOURCE.

NOTE 3 See Figure 2.
3.50
* NUISANCE ALARM SIGNAL

ALARM SIGNAL for which a panel of experts would agree that the HARM associated with the ALARM

SIGNAL is greater than the benefit associated with action resulting from the ALARM SIGNAL

NOTE 1 A NUISANCE ALARM SIGNAL contributes to ALARM FATIGUE.
NOTE 2 A NUISANCE ALARM SIGNAL can arise from a FALSE POSITIVE ALARM CONDITION.

NOTE 3 A NUISANCE ALARM SIGNAL can arise from a CLINICALLY NONACTIONABLE ALARM CONDITION.

NOTE 4 A NUISANCE ALARM SIGNAL can cause an inappropriate OPERATOR action.
EXAMPLE Causing the OPERATOR to set ALARM LIMITS to inappropriate settings.

NOTE 5 An ALARM SIGNAL that unnecessarily irritates or startles the PATIENT or OPERATOR can be a NUISANCE ALARM

SIGNAL.
3.51
REDIRECTION
INTEGRATOR provides a response hierarchy for directing an ALARM CONDITION
means by which an
to a COMMUNICATOR or transfers an ALARM CONDITION to another COMMUNICATOR
NOTE See Figure 2.
3.52
RESPONSIBILITY ACCEPTED

state created by an OPERATOR response accepting ownership for addressing an ALARM

CONDITION

NOTE 1 A RESPONSIBILITY ACCEPTED can be used to initiate an ALARM SIGNAL inactivation state.

NOTE 2 See Figure 2.
3.53
RESPONSIBILITY REJECTED

state created by an OPERATOR response rejecting ownership for addressing an ALARM CONDITION

NOTE 1 A RESPONSIBILITY REJECTED can be used to initiate an ESCALATION or REDIRECTION.

NOTE 2 See Figure 2.
3.54
RESPONSIBILITY UNDEFINED

state, automatically initiated when neither a RESPONSIBILITY ACCEPTED nor RESPONSIBILITY

REJECTED is received within a specified period, which indicates that an OPERATOR is not

responding

NOTE 1 RESPONSIBILITY UNDEFINED is not used as an indication that the COMMUNICATOR and INTEGRATOR cannot

communicate.
NOTE 2 See Figure 2.
---------------------- Page: 10 ----------------------
IEC 60601-1-8:2006/AMD2:2020 – 9 –
© IEC 2020
3.55
SOURCE
SRC
function that has the capability to initiate an ALARM CONDITION
NOTE 1 The SOURCE transfers the ALARM CONDITION to the INTEGRATOR.
NOTE 2 See Figure 2.
3.56
TRUE NEGATIVE ALARM CONDITION

absence of an ALARM CONDITION when no valid triggering event has occurred in the PATIENT, the

equipment or the ALARM SYSTEM
3.57
TRUE POSITIVE ALARM CONDITION

presence of an ALARM CONDITION when a valid triggering event has occurred in the PATIENT, the

equipment or the ALARM SYSTEM
6.2 * Disclosures for INTELLIGENT ALARM SYSTEM
Replace the existing list item e) with the following new item:

e) changes the characteristics of the generated ALARM SIGNALS (for example, volume, pitch,

tempo, urgency, AUDITORY ICON category).
6.3.1 General

Replace, in the first sentence of the existing first paragraph, "ALARM SIGNALS" with "ALARM

SIGNALS by a COMMUNICATOR".
6.3.2.2.2 1 m (OPERATOR’s POSITION) visual ALARM SIGNALS and INFORMATION SIGNALS

Replace, in the existing Note 3, modified by Amendment 1, "IEC 62366" with "IEC 62366-1".

Replace the existing Note 5, added by Amendment 1, with the following new note:

NOTE 5 It is recognized that visual INFORMATION SIGNALS and visual ALARM SIGNALS can sometimes contain identical

or similar information. When they are intended to convey different meanings, care needs to be taken to ensure that

visual ALARM SIGNALS cannot be confused with visual INFORMATION SIGNALS.
6.3.3.1 * Characteristics of auditory ALARM SIGNALS

Replace, in the existing first paragraph, modified by Amendment 1, the first sentence with:

If a COMMUNICATOR of an ALARM SYSTEM is provided with auditory ALARM SIGNALS:
Replace the existing list item b) to d), modified by Amendment 1, with:

b) of HIGH PRIORITY, the HIGH PRIORITY auditory ALARM SIGNALS of that COMMUNICATOR shall

convey a higher level of urgency than the MEDIUM or LOW PRIORITY auditory ALARM SIGNALS of

that ALARM SIGNAL set as well as a higher level of urgency than any auditory INFORMATION

SIGNAL

c) of MEDIUM PRIORITY, the MEDIUM PRIORITY auditory ALARM SIGNALS of that COMMUNICATOR shall

convey a higher level of urgency than the LOW PRIORITY auditory ALARM SIGNALS of that ALARM

SIGNAL set as well as a higher level of urgency than any auditory INFORMATION SIGNAL;

d) the COMMUNICATOR shall have at least one set of ALARM SIGNALS that:
1) complies with Annex G; or
---------------------- Page: 11 ----------------------
– 10 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
i) * A COMMUNICATOR with means to provide more than one set of auditory ALARM
SIGNALS should be equipped with at least one set of auditory ALARM SIGNALS that
complies with Annex G.
ALARM

2) * is generated by means of different technology (e.g. voice synthesizing of verbal

SIGNALS) and is VALIDATED (e.g. by clinical or simulated clinical USABILITY testing); or

3) * meets the requirements of Table 3 and Table 4.

Replace, in the existing Note 2, modified by Amendment 1, "IEC 62366" with "IEC 62366-1".

Delete the existing paragraph following Note 2.

Replace, in the third sentence of the existing compliance check, modified by Amendment 1,

"Verify" with "Confirm".
Delete t from the compliance check modified by Amendment 1.

Replace the existing last sentence of the compliance check, modified by Amendment 1, with

the following new sentence:

When the sound files of Annex G are utilized, only testing of t is required and testing of the

acoustic signal is permitted.

Replace the existing last paragraph, added by Amendment 1, with the following new paragraph:

Amongst the required frequency components with the largest sound pressure levels,

acoustically confirm the presence of at least one frequency component in range of 150 Hz to

1 000 Hz and at least the required components in the range of 150 Hz to 4 000 Hz in the auditory

ALARM SIGNAL at 1 m or the intended OPERATOR's POSITION. Only the AUDITORY POINTERS need

be tested when evaluating the ALARM SIGNALS of Annex G.
Table 3 – * Characteristics of the BURST of auditory ALARM SIGNALS

Replace, in the paragraph at the bottom of the table starting with "Where", modified by

Amendment 1, the third line with the following new text:
the variation of t , x and y within a BURST shall not exceed ± 20 %, and
Replace, in the existing table footnote c, "source" with "origin".
---------------------- Page: 12 ----------------------
IEC 60601-1-8:2006/AMD2:2020 – 11 –
© IEC 2020
Table 4 – * Characteristics of the PULSE of auditory ALARM SIGNALS

Replace the existing Table 4, modified by Amendment 1, with the following new table:

Characteristic Value

Frequency component in the range of 150 Hz to At least one that is among the four frequency

1 000 Hz components with the largest sound pressure level
Number of peaks in the frequency At least four peaks in the frequency domain
range of 150 Hz to 4 000Hz
Effective PULSE duration (t ) (see Figure 1)
75 ms to 200 ms
HIGH PRIORITY
125 ms to 250 ms
MEDIUM and LOW PRIORITY
RISE TIME (t ) (see Figure 1)
FALL TIME (t ) (see Figure 1)

Within the frequency range of 150 Hz to 4 000 Hz, the relative sound pressure levels of the four frequency

components with the largest sound pressure levels should be within 15 dB of each other.

NOTE Care is needed to ensure that the MEDIUM PRIORITY ALARM SIGNAL cannot be confused with the audible

emergency evacuation signal specified in ISO 8201:2017 [30].
The RISE TIME should not be so short as to create mechanical speaker noise.
The FALL TIME should be short enough to ensure that the PULSES do not overlap.
Figure 1 – Illustration of temporal characteristics of auditory ALARM SIGNALS
Replace, in the existing note, the word "NOTE" with "NOTE 1".
Add, after the existing note, the following new note:
NOTE 2 See Figure G.1 and Figure G.2 for additional information.

6.3.3.2 * Volume and characteristics of auditory ALARM SIGNALS and INFORMATION SIGNALS

Replace the existing first paragraph, modified by Amendment 1, with the following new

paragraph:

The auditory HIGH PRIORITY and MEDIUM PRIORITY ALARM SIGNAL sound pressure level range and

measurement radius, measured in accordance with the method of this subclause, shall be

ACCOMPANYING DOCUMENTS.
disclosed in the

Replace the existing list items c) to k), added by Amendment 1, with the following new items:

COMMUNICATOR on the floor and use a microph
...

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