IEC 60601-1-8:2006/Amd 2:2020

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Status
Published
Publication Date
22-Sep-2020
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
20-Jun-2020
Completion Date
19-Jun-2020
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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
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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".

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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:
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– 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
...

PROJET D’AMENDEMENT
IEC 60601-1-8:ISO custom-meta
generation-date/DAM 2
ISO/TC 121/SC 3 Secrétariat: ANSI
Début de vote: Vote clos le:
2019-05-24 2019-08-16
Appareils électromédicaux —
Partie 1-8:
Exigences générales pour la sécurité de base et les
performances essentielles — Norme collatérale: Exigences
générales, essais et guides pour les systèmes d'alarme des
appareils et des systèmes électromédicaux
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
AMENDMENT 2
ICS: 11.040.10
CE DOCUMENT EST UN PROJET DIFFUSÉ POUR
OBSERVATIONS ET APPROBATION. IL EST DONC
SUSCEPTIBLE DE MODIFICATION ET NE PEUT
ÊTRE CITÉ COMME NORME INTERNATIONALE
AVANT SA PUBLICATION EN TANT QUE TELLE.

Le présent document est distribué tel qu’il est parvenu du secrétariat du comité.

OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES
FINS INDUSTRIELLES, TECHNOLOGIQUES ET
COMMERCIALES, AINSI QUE DU POINT DE VUE
Ce projet est soumis à un vote parallèle à ISO et à IEC.
DES UTILISATEURS, LES PROJETS DE NORMES
INTERNATIONALES DOIVENT PARFOIS ÊTRE
CONSIDÉRÉS DU POINT DE VUE DE LEUR
POSSIBILITÉ DE DEVENIR DES NORMES
POUVANT SERVIR DE RÉFÉRENCE DANS LA
RÉGLEMENTATION NATIONALE.
Numéro de référence
LES DESTINATAIRES DU PRÉSENT PROJET
IEC 60601-1-8:2006/DAM 2:2019(F)
SONT INVITÉS À PRÉSENTER, AVEC LEURS
OBSERVATIONS, NOTIFICATION DES DROITS
DE PROPRIÉTÉ DONT ILS AURAIENT
ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE. IEC 2019
---------------------- Page: 1 ----------------------
62A/1325/CDV – 2 – IEC CDV 60601-1-8:2006/AMD2 © IEC:2019
1 AVANT-PROPOS

2 Le présent amendement a été établi par le sous-comité 62A: Aspects généraux des

3 équipements électriques utilisés en pratique médicale, du comité d’études 62 de l’IEC:

4 Équipements électriques dans la pratique médicale, et le sous-comité 3: Ventilateurs

5 pulmonaires et équipements connexes du comité technique 121 de l'ISO: Matériel d'anesthésie

6 et de réanimation respiratoire.
7 Le texte de cet amendement est issu des documents suivants:
FDIS Rapport de vote
62A/XXXX/FDIS 62A/XXXX/RVD

9 Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant

10 abouti à l'approbation de cet amendement.

11 Le comité a décidé que le contenu de cet amendement et de la publication de base ne sera pas

12 modifié avant la date de stabilité indiquée sur le site web de l'IEC sous

13 « http://webstore.iec.ch » dans les données relatives à la publication recherchée. À cette date,

14 la publication sera
15 • reconduite,
16 • supprimée,
17 • remplacée par une édition révisée, ou
18 • amendée.

19 Pour la présente publication, les Comités nationaux sont priés de noter que la date de

20 stabilité est 2024.

21 CE TEXTE EST INCLUS A TITRE D'INFORMATION POUR LES COMITES NATIONAUX. IL SERA SUPPRIME AU

22 STADE PUBLICATION.
IMPORTANT – Le logo « colour inside » qui se trouve sur la page de couverture de

cette publication indique qu'elle contient des couleurs qui sont considérées comme

utiles à une bonne compréhension de son contenu. Les utilisateurs devraient, par
conséquent, imprimer ce document en utilisant une imprimante couleur.
24 _____________

25 Note encadrée 1: Étant donné l’ampleur des modifications apportées par cet amendement, il a

26 été demandé aux Comités nationaux d’indiquer s’ils soutiendraient la publication finale en tant

27 que nouvelle édition de l’IEC 60601-1-8 plutôt qu’en tant que deuxième amendement tel qu’il a

28 été initialement prévu. Parmi les Comités nationaux qui ont répondu, le Comité national

29 allemand est fermement opposé à l’idée d’une nouvelle édition tandis que ceux de la Finlande et

30 de l’Afrique du Sud ont estimé qu’une nouvelle édition serait acceptable. À mesure que le projet

31 se poursuit, il convient que les Comités nationaux prennent en compte la section 2.10.3 des

32 directives ISO/IEC:

33 « Au stade approbation (voir 2.7), le Secrétaire général doit décider, en concertation avec le

34 secrétariat du comité technique ou du sous-comité, et en gardant à l'esprit à la fois les

35 conséquences financières pour l'organisation et les intérêts des utilisateurs de la Norme

36 internationale, s'il convient de publier un amendement ou une nouvelle édition de la Norme

37 internationale incorporant l'amendement. (Voir aussi 2.10.4.) »

38 En règle générale, si un amendement fait plus de 10 pages ou 15 % de la publication de base,

39 selon la plus petite des deux valeurs, il est d’usage que le Bureau central de l’IEC publie une

40 nouvelle édition complète plutôt que l’amendement.
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IEC CDV 60601-1-8:2006/AMD2 © IEC:2019 – 3 – 62A/1325/CDV
42 INTRODUCTION À L’AMENDEMENT 2

43 La deuxième édition de l‘IEC 60601-1-8 a été publiée en 2006 et amendée en 2012. Depuis la

44 publication de l’IEC 60601-1-8:2006/AMD1:2012, le Secrétariat du sous-comité (SC) 62A a

45 recueilli les préoccupations de différentes sources, y compris les commentaires des Comités

46 nationaux. Lors de la réunion du SC 62A de l’IEC en novembre 2015 à Kobe, au Japon, le

47 sous-comité a lancé un processus visant à identifier les questions hautement prioritaires qu’il y

48 a lieu de prendre en considération dans l’Amendement 2 et qu’il convient de traiter avant la

49 troisième édition, dont la publication est prévue peu après 2024.

50 Comme cela est spécifié au point 2 de la Résolution 1 de Kobe (62A/1069/RM), pour qu’une

51 question soit incluse dans la « sélection réduite » finale et soit traitée dans l’Amendement 2, la

52 question doit avoir été approuvée à la majorité des deux tiers des Comités nationaux présents

53 et votant à la réunion du SC 62A à Francfort. 20 points ont été présentés aux Comités nationaux

54 présents à la réunion du 10 octobre 2016. Les 20 points ont tous recueilli la majorité exigée des

55 2/3 des Comités nationaux présents et votants et ont été inclus dans la « sélection réduite »

56 pour examen lors de l’élaboration de l’Amendement 2. Toutes les questions restantes ont été

57 inscrites sur une « liste plus large » pour examen lors de la troisième édition.

58 La « sélection réduite » de questions a fait l’objet de documentation dans la Spécification de

59 conception de l’Amendement 2 (62A/1170/INF). L’IEC 60601-1-8 ayant été développée

60 conjointement avec le SC 3 du TC 121 de l’ISO, les travaux ont été confiés au Groupe de travail

61 commun (JWG) 2 IEC/SC 62A-ISO/TC 121/SC 3. Le JWG 2 a été chargé d’examiner les

62 questions décrites à l’Article 6 des spécifications de conception et de proposer une solution

63 appropriée au problème identifié. La solution finale proposée dans cet amendement peut inclure

64 les solutions techniques proposées par l’auteur de la question soulevée ou une solution

65 différente élaborée par le groupe d’experts. Le groupe d’experts a également pu indiquer que

66 l’énoncé du problème ne justifiait aucune modification de la norme.

67 Étant donné qu’il s’agit d’un amendement à l’édition 2006 de l’IEC 60601-1-8, le style en vigueur

68 à la date de publication de l’IEC 60601-1-8 a été appliqué au présent amendement. Le style

69 spécifié dans les directives ISO/IEC Partie 2:2018 n’a été appliqué que lorsque l’application du

70 nouveau guide stylistique n’entraînait pas de modifications rédactionnelles supplémentaires. Par

71 exemple, les notes aux définitions dans l’Article 3 sont désignées par « NOTE » plutôt que par

72 « Note à l’article ».

73 Il convient que les utilisateurs du présent document notent qu’à l’insertion des références

74 datées à des éléments spécifiques (aux définitions, par exemple) dans une norme, les

75 amendements ne sont référencés que s’ils modifient le texte cité. Par exemple, si une référence

76 est faite à une définition qui n’a pas été modifiée par un amendement, la référence à

77 l’amendement n’est pas incluse dans la référence datée.
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78 AVANT-PROPOS

79 Remplacer « l’Annexe H des Directives ISO/CEI, Partie 2 » par « l’Article 7 des directives

80 ISO/IEC, Partie 2:2018 » dans l’alinéa existant commençant par « Les formes verbales utilisées

81 dans la présente norme… »

82 Remplacer l’alinéa existant commençant par « Les articles, les paragraphes et les

83 définitions… » par:

84 Lorsqu’un astérisque (*) est utilisé comme premier caractère devant un titre, ou au début d’un

85 titre d’alinéa ou de tableau, il indique l’existence d’un guide ou d’une justification à consulter à

86 l’Annexe A.
87 INTRODUCTION

88 Dans la deuxième phrase du deuxième alinéa existant, remplacer « source » par « origine ».

89 Insérer, après le dernier alinéa existant de l’INTRODUCTION, les nouveaux alinéas suivants:

90 L’Amendement 1 à la présente norme a résolu la question des essais d’impulsions et de salves.

91 En outre, il a traité des points qui ont été soulevés par l’IEC/62D/MT 22, Appareils

92 électromédicaux de diagnostic et de surveillance des patients, au cours de la mise en œuvre

93 des exigences pour les SYSTEMES D'ALARME dans les normes particulières relevant de son

94 domaine de compétence.

95 L’Amendement 2 à la présente norme vise à traiter des questions hautement prioritaires

96 identifiées par une majorité des 2/3 des Comités nationaux présents et votants à la réunion de

97 l’IEC/SC 62A d’octobre 2016 à Francfort, en Allemagne, comme nécessitant d’être examinées

98 dans un amendement. Il convient, pour ce faire, de ne pas attendre la publication de la

99 troisième édition, dont la publication est prévue peu après 2024.
100 1 Domaine d'application, objet et normes connexes
101 1.3 Normes connexes
102 1.3.1 IEC 60601-1
103 Remplacer les textes existants des deux premiers tirets par:

104 ‒ « la norme générale » désigne l’IEC 60601-1 seule y compris les éventuels amendements;

105 ‒ « la présente norme collatérale » désigne l’IEC 60601-1-8 seule y compris les éventuels

106 amendements;
107 2 Références normatives

108 Note encadrée 2: Dans le cadre du projet en cours, des amendements à l’IEC 60601-1 ainsi

109 qu’un amendement à l’IEC 62366-1 sont en cours d’élaboration. Les références indiquées

110 ci-dessous seront mises à jour dès lors que le document a atteint le stade FDIS.

111 Remplacer, dans le premier alinéa existant, la première phrase par:

112 Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie

113 de leur contenu, des exigences du présent document.

114 Insérer, après le premier alinéa existant, la NOTE 1 et la NOTE 2 comme suit:

115 NOTE 1 La manière dont ces documents de référence sont cités dans les exigences normatives détermine la mesure

116 (en intégralité ou en partie) dans laquelle ils s’appliquent.
117 NOTE 2 Les références informatives sont répertoriées dans la bibliographie.
118 Mettre à jour les références normatives suivantes:

119 IEC 60601-1:2005, Appareils électromédicaux – Partie 1: Exigences générales pour la sécurité

120 de base et les performances essentielles
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IEC CDV 60601-1-8:2006/AMD2 © IEC:2019 – 5 – 62A/1325/CDV
121 IEC 60601-1:2005/AMD1:2012
122 IEC 60601-1:2005/AMD2:—
123 IEC 61672-1:2013, Électroacoustique – Sonomètres – Partie 1: Spécifications

124 IEC 62366-1:2015, Dispositifs médicaux – Application de l'ingénierie de l'aptitude à l'utilisation

125 aux dispositifs médicaux
126 IEC 62366-1:2015/AMD1:—
127 Ajouter les notes de bas de page 2) et 3) comme suit.

128 Il existe une édition consolidée 3.2 (—) incluant l’IEC 60601-1:2005, son Amendement 1 (2012) et son

129 Amendement 2 (—).

130 Il existe une édition consolidée 1.1 (—) incluant l’IEC 62366-1:2015 et son Amendement 1 (—).

131 3 Termes et définitions
132 Remplacer le premier alinéa existant par:
133 Pour les besoins du présent document, les termes et définitions donnés dans

134 l’IEC 60601-1:2005, l’IEC 60601-1:2005/AMD1:2012, l’IEC 60601-1:2005/AMD2:— et

135 l’IEC 62366-1:2015, ainsi que les suivants s’appliquent.

136 L'ISO et l'IEC tiennent à jour des bases de données terminologiques destinées à être utilisées

137 en normalisation, consultables aux adresses suivantes:
138 – IEC Electropedia: disponible à l’adresse http://www.electropedia.org/

139 – ISO Online browsing platform: disponible à l’adresse http://www.iso.org/obp

140 Remplacer la NOTE 2 existante par:

141 NOTE 2 Une liste des termes définis utilisés dans la présente norme collatérale est donnée dans l’index.

142 Remplacer le terme et la définition 3.17 existants par:
143 3.17
144 * SYSTEME D’ALARME REPARTI
145 DAS

146 SYSTEME D’ALARME qui implique plus d'un élément d’équipement dans un SYSTEME EM destiné à

147 fournir des CONDITIONS D’ALARME accompagnées d’une confirmation technique

148 NOTE 1 Les parties d'un SYSTEME D’ALARME REPARTI peuvent être situées à très grande distance les unes des

149 autres.

150 NOTE 2 Un SYSTEME D’ALARME REPARTI est destiné à informer les OPERATEURS de l’existence d’une CONDITION

151 D’ALARME.

152 NOTE 3 Pour les besoins du présent document, la confirmation technique signifie que chaque élément d’un SYSTEME

153 D’ALARME REPARTI confirme ou garantit la transmission réussie de la CONDITION D’ALARME au prochain élément ou que

154 des CONDITIONS D’ALARME TECHNIQUES appropriées sont créées, comme cela est décrit en 6.11.2.2.1.

155 NOTE 4 L’abréviation « DAS » est dérivée du terme anglais développé correspondant « distributed alarm system ».

156 Remplacer « appareil » par « SYSTEME D’ALARME » dans la note existante de la définition 3.20.

157 Remplacer la note existante de la définition 3.22 par ce qui suit:

158 NOTE 1 La priorité est attribuée dans le cadre d'une ANALYSE DE RISQUE. Voir 6.1.2 pour plus d’informations sur

159 l’attribution des priorités.

160 NOTE 2 « Immédiat » indique que l’interruption du flux de travaux en cours est attendue. [60], [61]

161 Ajouter une note après l’EXEMPLE 3 existant de la définition 3.23.
162 NOTE Une alerte est un type de SIGNAL D’INFORMATION.

163 Dans la parenthèse existante de la définition 3.25, remplacer « Figure 1 » par « Figure 1 et

164 Figure G.1 ».
165 Ajouter à la définition 3.25 la note suivante:
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62A/1325/CDV – 6 – IEC CDV 60601-1-8:2006/AMD2 © IEC:2019

166 NOTE Pour les besoins de la présente norme, l’INTERVALLE ENTRE SALVES commence à la fin de l’ICONE SONORE

167 lorsque ce dernier est utilisé.

168 Remplacer le terme, la définition et la note existants de la définition 3.27 par:

169 3.27
170 FAIBLE PRIORITE

171 indique que la vigilance de l’OPERATEUR est exigée ou une action future peut être nécessaire

172 NOTE 1 La priorité est attribuée dans le cadre d'une ANALYSE DE RISQUE. Voir 6.1.2 pour plus d’informations sur

173 l’attribution des priorités.

174 NOTE 2 « Vigilance » indique que la planification du flux de travaux futur peut être prévue. [60], [61]

175 Remplacer la note existante de la définition 3.28 par ce qui suit:

176 NOTE 1 La priorité est attribuée dans le cadre d'une ANALYSE DE RISQUE. Voir 6.1.2 pour plus d’informations sur

177 l’attribution des priorités.

178 NOTE 2 « Rapide » indique que la reprogrammation du flux de travaux en cours est attendue. [60], [61]

179 Remplacer le terme, la définition et les notes existants de la définition 3.37 par:

180 3.37
181 * ACQUITTE

182 état d'un SYSTEME D’ALARME initié par une action de l'OPERATEUR dans lequel le SIGNAL D’ALARME

183 sonore associé à une CONDITION D’ALARME active a été désactivé; cet état perdure jusqu'à ce que

184 la CONDITION D’ALARME soit résolue ou jusqu’à ce qu’un intervalle de temps prédéterminé soit

185 écoulé

186 ACQUITTE n'affecte que les SIGNAUX D’ALARME qui sont actifs au moment de l'action réalisée par

NOTE L'état
187 l'OPERATEUR.
188 Ajouter les nouvelles définitions suivantes:
189 3.38
190 FATIGUE LIEE AUX ALARMES

191 situation dans laquelle de fréquents SIGNAUX D’ALARME provoquent une désensibilisation de

192 l’OPERATEUR à un SIGNAL D’ALARME

193 NOTE 1 Un OPERATEUR désensibilisé peut échouer de percevoir, de reconnaître ou d’agir sur un SIGNAL D’ALARME.

194 NOTE 2 La réponse d’un OPERATEUR désensibilisé peut être inadéquate, retardée ou inexistante.

195 NOTE 3 L’INONDATION D’ALARME peut causer une FATIGUE LIEE AUX ALARMES.
196 3.39
197 INONDATION D’ALARME

198 état dans lequel les OPERATEURS reçoivent plus de SIGNAUX D’ALARME pendant une période

199 donnée qu’ils ne peuvent gérer de manière appropriée [57], [58]
200 3.40
201 * ALERTE
202 SIGNAL D’ALERTE

203 SIGNAL d’INFORMATION informant l'OPERATEUR de l’état du PATIENT ou de l'APPAREIL EM fournissant

204 une vigilance contextuelle destinée à améliorer le flux de travaux cliniques ou la compréhension

205 de l’état du PATIENT, mais cette vigilance n'est pas destinée à servir de moyen de MAITRISE DU

206 RISQUE

207 EXEMPLE 1 Une notification indiquant qu’il est temps de prélever le prochain échantillon de sang.

208 EXEMPLE 2 Une notification d’état de batterie indiquant que le remplacement sera nécessaire dans une journée.

209 EXEMPLE 3 Une notification indiquant qu'il est temps de laver le PATIENT.
210 3.41
211 ICONE SONORE
212 son qui crée un lien sémantique fort avec la catégorie qu’il représente

213 NOTE 1 Un ICONE SONORE est généralement un son du monde réel ou une imitation d’un son du monde réel.

214 NOTE 2 Un ICONE SONOre peut aider à localiser le COMMUNICATEUR et le type de SOURCE.

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IEC CDV 60601-1-8:2006/AMD2 © IEC:2019 – 7 – 62A/1325/CDV
215 3.42
216 INDICATEUR SONORE

217 son qui attire l’attention, indique la priorité et facilite la localisation du COMMUNICATEUR

218 3.43
219 * CLINIQUEMENT REALISABLE

220 type de CONDITION D’ALARME pour lequel un groupe d’experts convient que l’action de

221 l'OPERATEUR est nécessaire pour empêcher que des DOMMAGES ne surviennent dans les délais

222 prévus par la priorité attribuée par le SYSTEME D’ALARME

223 NOTE 1 Une action de l’OPERATEUR peut consister à évaluer un PATIENT ou à modifier les LIMITES D’ALARME

224 lorsqu'elles sont définies de manière inappropriée pour l’état du PATIENT.

225 NOTE 2 Une CONDITION D’ALARME DE FAIBLE PRIORITE, qui exige une action dans les délais impartis d’une PRIORITE

226 MOYENNE ou d’une PRIORITE ELEVEE, est considérée comme étant CLINIQUEMENT REALISABLE. Une CONDITION D’ALARME

227 DE PRIORITE ELEVEE, qui exige une action dans les délais impartis d’une FAIBLE PRIORITE ou d’une PRIORITE MOYENNE,

228 est considérée comme étant cliniquement non réalisable. Dans les deux cas, la priorité de la CONDITION D’ALARME n’a

229 pas été correctement attribuée.

230 NOTE 3 Une FAUSSE CONDITION D’ALARME POSITIVE n'est jamais considérée comme étant CLINIQUEMENT REALISABLE,

231 même si une action indépendante de l’OPERATEUR peut être exigée pour éviter une future FAUSSE CONDITION D’ALARME

232 POSITIVE.

233 NOTE 4 Une CONDITION D’ALARME CLINIQUEMENT REALISABLE est généralement considérée comme utile pour

234 l’OPERATEUR.
235 3.44
236 * CLINIQUEMENT NON REALISABLE

237 type de CONDITION D’ALARME pour lequel un groupe d’experts convient que l’action de

238 l'OPERATEUR n’est pas attendue dans un délai inférieur ou égal au délai prévu par sa priorité

239 NOTE 1 Une CONDITION D’ALARME DE FAIBLE PRIORITE, qui exige une action dans les délais impartis d’une priorité

240 moyenne ou d’une priorité élevée, est considérée comme étant CLINIQUEMENT REALISABLE. Une CONDITION D’ALARME DE

241 PRIORITE ELEVEE, qui exige une action dans les délais impartis d’une FAIBLE PRIORITE ou d’une PRIORITE MOYENNE, est

242 considérée comme étant CLINIQUEMENT NON REALISABLE. Dans les deux cas, la priorité de la CONDITION D’ALARME n’a

243 pas été correctement attribuée.

244 NOTE 2 Les conditions d’alarme CLINIQUEMENT NON REALISABLES sont considérées comme étant préjudiciables aux

245 performances de l’OPERATEUR et à la sécurité du PATIENT.

246 NOTE 3 Les SIGNAUX D’ALARME d’une CONDITION D’ALARME dont l’OPERATEUR a déjà connaissance sont considérés

247 comme CLINIQUEMENT NON REALISABLES.
248 3.45
249 COMMUNICATEUR
250 COM
251 ANNONCIATEUR

252 fonction du SYSTEME D’ALARME qui génère des SIGNAUX D’ALARME pour avertir un OPERATEUR

253 NOTE 1 Un COMMUNICATEUR peut recevoir une réponse de l’OPERATEUR.

254 NOTE 2 La réponse de l’OPERATEUR n’est pas limitée à une action directe de l’OPERATEUR.

255 3.46
256 SYSTEME D’ALARME REPARTI AVEC CONFIRMATION DE L’OPERATEUR
257 CDAS

258 SYSTEME D’ALARME REPARTI équipé de la capacité de recevoir une réponse de l’OPERATEUR

259 NOTE 1 L’abréviation « CDAS » est dérivée du terme anglais développé correspondant « distributed alarm system

260 with operator confirmation ».
261 3.47
262 * SYSTEME D’INFORMATION REPARTI SUR LES CONDITIONS D’ALARME
263 DIS

264 système qui implique plus d’un élément d’équipement d’un SYSTEME EM destiné à fournir des

265 informations sur les CONDITIONS D’ALARME, mais ne garantit pas la transmission de ces

266 informations

267 NOTE 1 Un SYSTEME D’INFORMATION REPARTI SUR LES CONDITIONS D’ALARME n'est pas destiné à informer les

268 OPERATEURS de l'existence d'une CONDITION D’ALARME à titre de mesure de MAITRISE DU RISQUE. Un SYSTEME

269 D’INFORMATION REPARTI SUR LES CONDITIONS D’ALARME vise à fournir de l’information sur une CONDITION D’ALARME

270 pendant que l’OPERATEUR est informé de l’existence de cette CONDITION D’ALARME par un SYSTEME D’ALARME.

271 NOTE 2 Un SYSTEME D’INFORMATION REPARTI SUR LES CONDITIONS D’ALARME n'est pas destiné à permettre l’existence

272 confirmée des CONDITIONS D’ALARME.
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273 NOTE 3 L’abréviation « DIS » est dérivée du terme anglais développé correspondant « distributed information

274 system about alarm conditions ».
275 3.48
276 INTEGRATEUR
277 INT
278 GESTIONNAIRE D’ALARME

279 fonction du SYSTEME D’ALARME qui gère la communication entre SOURCES et COMMUNICATEURS ou

280 avec d’autres INTEGRATEURS

281 NOTE 1 Un INTEGRATEUR peut diriger ou rediriger une CONDITION D’ALARME vers un autre COMMUNICATEUR et, par

282 conséquent, vers l’OPERATEUR.

283 NOTE 2 Un INTEGRATEUR peut transmettre l’acceptation de la responsabilité d’un COMMUNICATEUR à une SOURCE.

284 3.49
285 * SIGNAL D’ALARME NUISIBLE

286 SIGNAL D’ALARME pour lequel un groupe d’experts conviendrait que les DOMMAGES associés à ce

287 SIGNAL D’ALARME sont supérieurs aux avantages associés à une action résultant du SIGNAL

288 D’ALARME
289 NOTE 1 Un SIGNAL D’ALARME NUISIBLE contribue à la FATIGUE LIEE AUX ALARMES.

290 NOTE 2 Un SIGNAL D’ALARME NUISIBLE peut provenir d’une CONDITION D’ALARME CLINIQUEMENT NON REALISABLE.

291 NOTE 3 Un SIGNAL D’ALARME NUISIBLE peut provoquer une action inappropriée de l’OPERATEUR.

292 EXEMPLE L'OPERATEUR est amené à définir des LIMITES D’ALARME pour des réglages inappropriés.

293 NOTE 4 Un SIGNAL D’ALARME qui irrite ou fait sursauter inutilement le PATIENT ou l’OPERATEUR peut être considéré

294 comme un SIGNAL D’ALARME NUISIBLE.
295 3.50
296 REDIRECTION

297 moyen par lequel un INTEGRATEUR fournit une hiérarchie de réponses pour diriger une CONDITION

298 D’ALARME vers un COMMUNICATEUR ou redirige une CONDITION D’ALARME vers un autre

299 COMMUNICATEUR
300 3.51
301 RESPONSABILITE ACCEPTEE

302 état créé par une réponse de l’OPERATEUR acceptant d’être propriétaire de l’adressage d’une

303 CONDITION D’ALARME

304 NOTE Une RESPONSABILITE ACCEPTEE peut être utilisée pour initier un état de désactivation du SIGNAL D’ALARME.

305 3.52
306 RESPONSABILITE REJETEE

307 état créé par une réponse de l’OPERATEUR rejetant d’être propriétaire de l’adressage d’une

308 CONDITION D’ALARME

309 NOTE Une RESPONSABILITE REJETEE peut être utilisée pour initier une AUGMENTATION DU NIVEAU DE PRIORITE ou une

310 REDIRECTION.
311 3.53
312 RESPONSABILITE NON DEFINIE

313 état initié automatiquement lorsque ni une RESPONSABILITE ACCEPTEE ni une RESPONSABILITE

314 REJETEE ne sont reçues dans un délai spécifié, ce qui indique qu’un OPERATEUR ne répond pas

315 NOTE L’état RESPONSABILITE NON DEFINIE n’est pas utilisé pour indiquer que le COMMUNICATEUR et l’INTEGRATEUR ne

316 peuvent pas communiquer.
317 3.54
318 SOURCE
319 SRC
320 fonction qui a la capacité d’initier une CONDITION D'ALARME
321 NOTE La SOURCE peut accepter une attribution de responsabilité.
322 3.55
323 VRAIE CONDITION D’ALARME NEGATIVE

324 absence de CONDITION D’ALARME lorsqu’aucun événement déclenchant valable n’est apparu

325 concernant le PATIENT, l’appareil ou le SYSTEME D’ALARME
---------------------- Page: 8 ----------------------
IEC CDV 60601-1-8:2006/AMD2 © IEC:2019 – 9 – 62A/1325/CDV
326 3.56
327 VRAIE CONDITION D’ALARME POSITIVE

328 présence d'une CONDITION D’ALARME lorsqu'un événement déclenchant valable est apparu

329 concernant le PATIENT, l'appareil ou le SYSTEME D’ALARME
330 6 SYSTEMES D’ALARME
331 6.2 * INDICATIONS POUR LES SYSTEMES D’ALARME INTELLIGENTS
332 Remplacer le point e) existant par:

333 e) change les caractéristiques des SIGNAUX D’ALARME générés (par exemple volume, tonie,

334 tempo, urgence, catégorie d’ICONE SONORE).
335 6.3 Génération des SIGNAUX D’ALARME
336 6.3.1 Généralités

337 Remplacer la première phrase du premier alinéa existant par la suivante: « Chaque CONDITION

338 D’ALARME doit provoquer la génération de SIGNAUX D’ALARME visuels par un COMMUNICATEUR

339 comme cela est spécifié dans la norme collatérale. »
340 6.3.2 * SIGNAUX D’ALARME VISUELS
341 6.3.2.2 * Caractéristiques des SIGNAUX D’ALARME visuels

342 6.3.2.2.2 SIGNAUX D’ALARME visuels à 1 m (POSITION de l’opérateur) et SIGNAUX

343 D’INFORMATION
344 Remplacer, dans la NOTE 3 existante, « la CEI 62366 » par « l’IEC 62366-1 ».
345 Remplacer la NOTE 5 existante par ce qui suit:

346 NOTE 5 Il est reconnu que les SIGNAUX D’INFORMATION VISUELS et les SIGNAUX D’ALARME visuels peuvent parfois

347 contenir des informations identiques ou similaires. Il y a lieu de veiller à ce que les SIGNAUX D’ALARME visuels ne

348 puissent pas être confondus avec les SIGNAUX D’INFORMATION VISUELS lorsqu’ils sont destinés à véhiculer des

349 significations différentes.
350 6.3.3 * SIGNAUX D’ALARME SONORES
351 6.3.3.1 * Caractéristiques des SIGNAUX D’ALARME sonores
352 Remplacer, dans le premier alinéa existant, la première phrase par:

353 Si un COMMUNICATEUR d’un SYSTEME D’ALARME intègre des SIGNAUX D’ALARME sonores:

354 Remplacer les points b) à d) existants par:
355 b) de PRIORITE ELEVEE, les SIGNAUX D’ALARME sonores de PRIORITE ELEVEE de ce

356 COMMUNICATEUR doivent donner un niveau d'urgence supérieur à celui des SIGNAUX D’ALARME

357 sonores de PRIORITE MOYENNE ou FAIBLE de ce jeu de SIGNAUX D’ALARME, ainsi qu'un niveau

358 d'urgence supérieur à celui de tout SIGNAL D’INFORMATION sonore;

359 c) de PRIORITE MOYENNE, les SIGNAUX D’ALARME sonores de PRIORITE MOYENNE de ce

360 COMMUNICATEUR doivent donner un niveau d'urgence supérieur à celui des SIGNAUX D’ALARME

361 sonores de FAIBLE PRIORITE de ce jeu de SIGNAUX D’ALARME, ainsi qu'un niveau d'urgence

362 supérieur à celui de tout SIGNAL D’INFORMATION sonore;
363 d) le COMMUNICATEUR doit posséder au moins un jeu de SIGNAUX D’ALARME:
364 1) conforme à l’Annexe G; ou

365 i) * Il convient qu’un COMMUNICATEUR ayant les moyens de fournir plus d’un jeu de

366 SIGNAUX D’ALARME sonores soit équipé d'au moins un jeu de sIGNAUX D’ALARME
367 sonores conforme à l'Annexe G.

368 2) * généré au moyen de différentes technologies (par exemple, synthétiseur de SIGNAUX

369 D’ALARME vocaux) et qui est VALIDE (par exemple, par des essais cliniques ou des essais

370 cliniques simulés d'APTITUDE A L’UTILISATION); ou
371 3) qui satisfait aux exigences des Tableaux 3 et 4.
372 Remplacer « la CEI 62366 » par « l’IEC 62366-1 » dans la NOTE 2 existante.
373 Supprimer l’alinéa existant qui suit la NOTE 2.
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62A/1325/CDV – 10 – IEC CDV 60601-1-8:2006/AMD2 © IEC:2019

374 Remplacer « Vérifier » par « Confirmer » dans la troisième phrase du premier alinéa existant de

375 la vérification de conformité.
376 Supprimer t de la vérification de conformité.

377 Remplacer la dernière phrase existante du premier alinéa de la vérification de conformité par:

378 Lorsque les fichiers sonores de l'Annexe G sont utilisés, seuls les essais de t sont exigés et les

379 essais du signal acoustique sont autorisés.
380 Remplacer le second alinéa existant de la vérification de conformité par:

381 Dans les fréquences exigées, les composantes présentant les niveaux de pression acoustique

382 les plus élevés, confirment de manière acoustique la présence d'au moins une composante de

383 fréquence dans la plage de 150 Hz à 1 000 Hz et d'au moins les composantes exigées dans la

384 plage de 150 Hz à 4 000 Hz dans le SIGNAL D’ALARME sonore à 1 m ou à la position prévue de

385 l’opérateur. Lors de l’évaluation des SIGNAUX D’ALARME de l’Annexe G, il y a lieu de ne soumettre

386 à l’essai que les INDICATEURS SONORES.
387 Tableau 3 – * Caractéristiques de la SALVE des SIGNAUX D’ALARME SONORES

388 Dans la cinquième ligne existante du Tableau 3, remplacer la troisième ligne de texte suivant

389 « Où: » par:
390 la variation de t , x et y dans une SALVE ne doit pas dépasser ± 20 %, et
391 Remplacer, dans la note de bas de ta
...

FINAL
IEC
AMENDMENT
DRAFT
60601-1-8:2006
FDAM 2
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Voting begins on:
Part 1-8:
2020-04-24
General requirements for basic safety
Voting terminates on:
and essential performance — Collateral
2020-06-19
standard: General requirements,
tests and guidance for alarm systems
in medical electrical equipment and
medical electrical systems
AMENDMENT 2
Appareils électromédicaux —
Partie 1-8: Exigences générales pour la sécurité de base et les
performances essentielles — Norme collatérale: Exigences générales,
essais et guides pour les systèmes d'alarme des appareils et des
systèmes électromédicaux
AMENDEMENT 2
This draft is submitted to a parallel vote in ISO and in IEC.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
IEC 60601-1-8:2006/FDAM 2:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. IEC 2020
---------------------- Page: 1 ----------------------
– 2 – IEC FDIS 60601-1-8:2006/AMD2
© 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/XXX/FDIS 62A/XXX/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 XXX P

members out of YYY 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.

_____________
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IEC FDIS 60601-1-8:2006/AMD2 – 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.
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– 4 – IEC FDIS 60601-1-8:2006/AMD2
© 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".

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IEC FDIS 60601-1-8:2006/AMD2 – 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:
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© 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 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 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

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IEC FDIS 60601-1-8:2006/AMD2 – 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. 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.
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– 8 – IEC FDIS 60601-1-8:2006/AMD2
© 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

means by which an INTEGRATOR provides a response hierarchy for directing an ALARM CONDITION

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.
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IEC FDIS 60601-1-8:2006/AMD2 – 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
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– 10 – IEC FDIS 60601-1-8:2006/AMD2
© 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".
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IEC FDIS 60601-1-8:2006/AMD2 – 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 4 000 Hz
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: 11 ----------------------
– 12 – IEC FDIS 60601-1-8:2006/AMD2
© 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 for each component of a DIS or DAS, as applicable:
c) from:
1) the onset of the ALARM CONDITION;
2) the time of the ALARM SIGNAL generation at the SOURCE;

3) the point that the presentation of the ALARM CONDITION leaves the SIGNAL INPUT/OUTPUT

PART of the SOURCE or INTEGRATOR; or

4) the point that the presentation of the ALARM CONDITION arrives at the SIGNAL INPUT/OUTPUT

PART of the INTEGRATOR or COMMUNICATOR;
d) to:

1) the point that the presentation of the ALARM CONDITION leaves the SIGNAL INPUT/OUTPUT

PART of the SOURCE or INTEGRATOR;

2) the point that the presentation of the ALARM CONDITION arrives at the SIGNAL INPUT/OUTPUT

PART of the INTEGRATOR or COMMUNICATOR; or
3) the time of the ALARM SIGNAL generation at the COMMUNICATOR.

Compliance is checked by functional testing under maximum load conditions of NORMAL USE and

inspection of the instructions for use.
6.5.4.2 * Selection of DEFAULT ALARM PRESET
Add, after the existing list item g), the following note:
---------------------- Page: 12 ----------------------
IEC FDIS 60601-1-8:2006/AMD2 – 13 –
© IEC 2020

NOTE Care is needed to ensure that the OPERATOR is aware of which previously retained ALARM SETTINGS are

being restored when the OPERATOR selects the retained ALARM SETTINGS.
Delete, in the existing compliance check, the word "source".
6.5.5 * Interruptions of less than or equal to 30 s
Delete, in the existing compliance check, the word "source".
6.7 * ALARM SYSTEM security

Replace, in the existing first paragraph, modified by Amendment 1, ''6.10 and 6.11.2.2.1" with

"6.10, 6.11.2.2.1 and 6.12.3."
6.8.1 * General
Add, after the existing third paragraph, the following new paragraph and note:

During the ALARM OFF or ALARM PAUSED ALARM SIGNAL inactivation states, the ALARM SYSTEM may

discontinue the processing of signals used to generate the inactivated ALARM CONDITIONS.

NOTE 3 If the ALARM SYSTEM discontinues the processing of a signal used to generate an ALARM CONDITION, the

ALARM SYSTEM log cannot log that ALARM CONDITION.
Renumber the existing Note 3, modified by Amendment 1, as Note 4.
Table 5 – ALARM SIGNAL inactivation states

Replace the existing fifth and sixth rows of Table 5, modified by Amendment 1, with the

following:
7 or 13
Indefinite ALARM CONDITION no 5 or
or 6
ACKNOWLEDGED
...

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