SIST EN 60601-1-8:2008/A2:2021

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/A2:2020)

2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) and M/432

Medizinische elektrische Geräte - Teil 1-8: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Alarmsysteme - Allgemeine Festlegungen, Prüfungen und Richtlinien für Alarmsysteme in medizinischen elektrischen Geräten und in medizinischen Systemen (IEC 60601-1-8:2006/A2:2020)

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/A2:2020)

Medicinska električna oprema - 1-8. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Splošne zahteve, preskušanje in navodila za alarmne sisteme v medicinski električni opremi in medicinskih električnih sistemih - Dopolnilo A2 (IEC 60601-1-8:2006/A2:2020)

General Information

• Status: Published
• Publication Date: 22-Aug-2021
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 27-Jul-2021
• Due Date: 01-Oct-2021
• Completion Date: 23-Aug-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: EN 60601-1-8:2007/A2:2021 - 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

Overview

EN 60601-1-8:2007/A2:2021 (aligned with IEC 60601-1-8:2006/A2:2020) is a collateral standard for medical electrical equipment that defines general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. Amendment A2 updates definitions, priorities and alarm system concepts (for example Distributed Alarm System, Advisory, Alarm Fatigue, Alarm Flood) and updates normative references. The amendment was prepared by IEC SC 62A with ISO input and adopted by CENELEC in 2020–2021.

Key topics and technical requirements

• Scope and purpose
  • Sets requirements for alarm signals, alarm categories and alarm performance to support safe clinical decision-making and patient care.
• Terminology and definitions
  • Introduces and clarifies terms such as DISTRIBUTED ALARM SYSTEM (DAS), ADVISORY, ACKNOWLEDGED, ALARM FATIGUE and ALARM FLOOD.
• Alarm priority and risk-based assignment
  • Priorities (High, Medium, Low) are assigned through risk analysis and have defined expectations for operator response and workflow interruption.
• Alarm signal design
  • Guidance for auditory/visual signals (including auditory icons and interburst intervals) to minimise confusion between advisories and alarms and to reduce alarm fatigue.
• System behaviour
  • Requirements on alarm delivery, technical confirmation in distributed systems, acknowledgement behavior and handling of false negatives.
• Usability and acoustics
  • Normative cross-references to IEC 62366-1 (usability) and IEC 61672-1 (sound level meters) to ensure alarm signals are perceptible and usable in clinical environments.
• Tests and verification
  • Specifies testing approaches and references for measuring acoustic characteristics and functional delivery of alarm conditions (see annexes and normative references).

Practical applications

• Design and validation of alarm subsystems in:
  • Patient monitors, ventilators, infusion pumps, anaesthesia machines and integrated medical systems.
• Clinical alarm management programs in hospitals to reduce alarm fatigue and improve patient safety.
• Usability engineering during product development to ensure alarms are interpretable and actionable.
• Conformity assessment and type testing by test laboratories and notified bodies.

Who should use this standard

• Medical device manufacturers (hardware and software)
• Biomedical engineers and clinical engineers
• Usability specialists and human factors engineers
• Test laboratories, regulatory compliance teams and hospital safety managers

Related standards

• IEC 60601-1 (general standard for basic safety and essential performance)
• IEC 62366-1 (usability engineering)
• IEC 61672-1 (electroacoustics / sound level meters)
• ISO 3744, ISO/IEEE 11073 series (relevant references)

This standard is essential when designing, testing or implementing alarm functions that must be safe, usable and effective in clinical practice.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2021
Medicinska električna oprema - 1-8. del: Splošne zahteve za osnovno varnost in
bistvene lastnosti - Spremljevalni standard: Splošne zahteve, preskušanje in
navodila za alarmne sisteme v medicinski električni opremi in medicinskih
električnih sistemih - Dopolnilo A2 (IEC 60601-1-8:2006/A2:2020)
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/A2:2020)
Medizinische elektrische Geräte - Teil 1-8: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Alarmsysteme -
Allgemeine Festlegungen, Prüfungen und Richtlinien für Alarmsysteme in medizinischen
elektrischen Geräten und in medizinischen Systemen (IEC 60601-1-8:2006/A2:2020)
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/A2:2020)
Ta slovenski standard je istoveten z: EN 60601-1-8:2007/A2:2021
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-1-8:2007/A2

NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2021
ICS 11.040.01
English Version
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/A2:2020)
Appareils électromédicaux - Partie 1-8 : exigences Medizinische elektrische Geräte - Teil 1-8: Allgemeine
générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles - Norme collatérale: exigences générales, wesentlichen Leistungsmerkmale - Ergänzungsnorm:
essais et guide pour les systèmes d'alarme des appareils et Alarmsysteme - Allgemeine Festlegungen, Prüfungen und
des systèmes électromédicaux Richtlinien für Alarmsysteme in medizinischen elektrischen
(IEC 60601-1-8:2006/A2:2020) Geräten und in medizinischen Systemen
(IEC 60601-1-8:2006/A2:2020)
This amendment A2 modifies the European Standard EN 60601-1-8:2007; it was approved by CENELEC on 2020-08-27. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the
status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-1-8:2007/A2:2021 E

European foreword
The text of document 62A/1392/FDIS, future IEC 60601-1-8/A2, prepared by SC 62A "Common
aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in
medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-01-16
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-07-16
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-1-8:2006/A2:2020 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 80001-1 NOTE Harmonized as EN 80001-1
ISO 9000:2015 NOTE Harmonized as EN ISO 9000:2015 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.
Replace Annex ZA by the following one:
Publication Year Title EN/HD Year
IEC 60417 - Graphical symbols for use on equipment. - -
Index, survey and compilation of the single
sheets.
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014
+ A2 2020  + A2 2021
IEC 61672-1 2013 Electroacoustics - Sound level meters - EN 61672-1 2013
Part 1: Specifications
IEC 62366-1 2015 Medical devices - Part 1: Application of EN 62366-1 2015
usability engineering to medical devices
- -  + AC 2015
+ A1 2020  + A1 2020
ISO 3744 2010 Acoustics - Determination of sound power EN ISO 3744 2010
levels and sound energy levels of noise
sources using sound pressure -
Engineering methods for an essentially
free field over a reflecting plane
ISO 7000 - Graphical symbols for use on equipment - - -
Registered symbols
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

– 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.

_____________
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.
– 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".

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:

– 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

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.
– 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.
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
– 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.
r
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
b
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
d
Replace, in the existing table footnote c, "source" with "origin".

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)
d
75 ms to 200 ms
HIGH PRIORITY
125 ms to 250 ms
MEDIUM and LOW PRIORITY
a
RISE TIME (t ) (see Figure 1)
r
b
FALL TIME (t ) (see Figure 1)
f
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].
a
The RISE TIME should not be so short as to create mechanical speaker noise.
b
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
O
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.
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© 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:

IEC 60601-1-8:2006/AMD2:2020 – 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 longer exists 8 or 14
8 or 14
ALARM CONDITION no 7 or 13
Timed 6 or
longer exists or time or 7
ACKNOWLEDGED 9 or 15
interval elapsed 9 or 15
6.11 * DISTRIBUTED ALARM SYSTEM
Replace the existing title and the entire subclause 6.11 with:
6.11 * DISTRIBUTED ALARM SYSTEMS and DISTRIBUTED INFORMATION SYSTEMS ABOUT ALARM
CONDITIONS
6.11.1 * Existence of a DIS or DAS
The details necessary for the safe use of a DIS or a DAS shall be disclosed in the technical
description. A DIS or a DAS is a permitted form of an ALARM SYSTEM. Figure 2 illustrates the
functions of a DISTRIBUTED ALARM SYSTEM utilizing a MEDICAL IT NETWORK.
NOTE Additional information is found in IEC 80001-2-5 [31].

– 14 – IEC 60601-1-8:2006/AMD2:2020
© IEC 2020
NOTE This is a functional diagram and does not imply that these functions are in separate components. It is possible
for functionality to be provided in one or more components.
Figure 2 – Functions of a DISTRIBUTED ALARM SYSTEM utilizing a MEDICAL IT NETWORK
An ALARM SYSTEM is permitted to send or receive data, including the indication of INFORMATION
SIGNALS and ALARM CONDITIONS, to or from other parts of a DIS or a DAS. A DIS or a DAS is
permitted to be located outside of the PATIENT ENVIRONMENT. Part(s) of a DIS or a DAS are
permitted to be located outside of the PATIENT ENVIRONMENT. Data are permitted to be
transmitted between different parts of a DIS or a DAS by wire, by telemetry or by other means.
EXAMPLE 1 A central station.
EXAMPLE 2 An electronic record-keeping device.
EXAMPLE 3 Remote viewing from home or office.
EXAMPLE 4 Bed-to-bed viewing of ALARM CONDITIONS (e.g. one nurse for two beds).
EXAMPLE 5 Transmission of ALARM CONDITIONS to pagers, cell phones, hand-held computers, etc.
Compliance is checked by inspection of the technical description.
6.11.2 Requirements for communication of ALARM CONDITIONS
6.11.2.1 SOURCE and identification of ALARM CONDITIONS
In a DAS or DIS, means shall be provided to identify the SOURCE of the ALARM CONDITION at every
COMMUNICATOR that generates ALARM SIGNALS for that ALARM CONDITION.
ALARM SIGNALS that indicate the urgency of the response required, categorization of the cause
of the ALARM CONDITION and identification of the PATIENT, equipment or PATIENT's location should
also be generated by the DISTRIBUTED ALARM SYSTEM.

IEC 60601-1-8:2006/AMD2:2020 – 15 –
© IEC 2020
Compliance is checked by inspection.
6.11.2.2 * Failure of remote communication of ALARM CONDITIONS
6.11.2.2.1 * DAS or CDAS
A DAS or CDAS shall be so designed that a communications failure or failure in any remote
component of the DAS or CDAS:
DAS or CDAS other than the loss of the distributed
a) shall not adversely affect any part of the
functionality; and
b) shall initiate a TECHNICAL ALARM CONDITION for all relevant COMMUNICATORS of the DAS or
CDAS.
1) The ALARM SYSTEM should provide a means for the OPERATOR to inactivate any auditory
ALARM SIGNALS of this TECHNICAL ALARM CONDITION.
MANUFACTURERS should take care in the design of ME EQUIPMENT to ensure that it reverts to a
safe mode of operation, which can include ESCALATION of the volume of auditory ALARM SIGNALS
or utilization of a redundant communication pathway.
Compliance is checked by functional testing and inspection of the ALARM SYSTEM.
IS
6.11.2.2.2 * D
A DIS shall be so designed that a communications failure or failure in any remote component of
DIS:
the
a) shall not adversely affect any part of the DIS other than the loss of the distributed
functionality; and
b) any remote COMMUNICATOR of a DIS that cannot comply with 6.11.2.2.1 shall be marked with
a warning to the effect that it shall not be relied upon for receipt of ALARM SIGNALS.
EXAMPLE A one-way paging system requires such a warning.
NOTE Inability to successfully send or receive ALARM CONDITIONS or INFORMATION SIGNALS is considered a failure.
Compliance is checked by functional testing and inspection of the ALARM SYSTEM.
6.11.2.2.3 * SOURCE with a global AUDIO OFF in a DISTRIBUTED ALARM SYSTEM
If there is a communications failure between a SOURCE with a global AUDIO OFF and the
DISTRIBUTED ALARM SYSTEM, the affected SOURCE shall terminate the global AUDIO OFF state, if
active.
If the OPERATOR subsequently activates AUDIO OFF or a global AUDIO OFF in the SOURCE,
continuing failure of the link need not cause additional auditory ALARM SIGNALS.
Compliance is checked by functional testing and inspection of the ALARM SYSTEM.
6.11.2.3 * Remote ALARM SYSTEM controls
A DAS or CDAS may provide remote OPERATOR access to some or all ALARM SYSTEM controls. If
provided:
a) the ALARM SYSTEM shall provide a means for the RESPONSIBLE ORGANIZATION to restrict
remote OPERATOR access to the available remote controls; and
b) such means shall be restricted to the RESPONSIBLE ORGANIZATION, preventing the clinical
OPERATOR from changing the configuration (see 6.7).
Compliance is checked by functional testing and inspection of the ALARM SYSTEM.

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© IEC 2020
6.11.2.4 * CDAS
In a CDAS, the COMMUNICATOR that receives an ALARM CONDITION shall have means to create the
OPERATOR responses (RESPONSIBILITY ACCEPTED or RESPONSIBILITY REJECTED) and transfer them
to the INTEGRATOR.
a) In a CDAS, the COMMUNICATOR that receives an ALARM CONDITION and initiates an OPERATOR
response (RESPONSIBILITY ACCEPTED or RESPONSIBILITY REJECTED) shall indicate the
OPERATOR response state (RESPONSIBILITY ACCEPTED or RESPONSIBILITY REJECTED).
The means of control used to initiate an OPERATOR response or indication of state may be
marked with:
b) symbol ISO 7000-6334A (2015-06) (see Symbol 13 of Table C.1) for RESPONSIBILITY
ACCEPTED; or
RESPONSIBILITY
c) symbol ISO 7000-6335A (2015-06) (see Symbol 16 of Table C.1) for
REJECTED.
Means shall be provided for the OPERATOR to terminate RESPONSIBILITY ACCEPTED or
RESPONSIBILITY REJECTED while the related ALARM CONDITION is active. Initiating RESPONSIBILITY
REJECTED may be used to terminate RESPONSIBILITY ACCEPTED. Initiating RESPONSIBILITY
ACCEPTED may be used to terminate RESPONSIBILITY REJECTED.
In a CDAS, RESPONSIBILITY ACCEPTED may initiate an ALARM SIGNAL inactivation state.
NOTE RESPONSIBILITY ACCEPTED is a different function than an ALARM SIGNAL inactivation state.
In a CDAS, the INTEGRATOR shall have means to accept OPERATOR responses from the
COMMUNICATOR.
In a CDAS, the SOURCE may receive OPERATOR responses from the INTEGRATOR.
Compliance is checked by functional testing and inspection of the ALARM SYSTEM.
6.12 * ALARM SYSTEM logging
Replace the existing subclause 6.12, modified by Amendment 1, with:
6.12.1 General
An ALARM SYSTEM may be equipped with an OPERATOR ALARM SYSTEM log or a RESPONSIBLE
ORGANIZATION ALARM SYSTEM log.
An OPERATOR ALARM SYSTEM log is intended to be utilized while the ALARM SYSTEM is being used
for a PATIENT. A RESPONSIBLE ORGANIZATION ALARM SYSTEM log is intended to be utilized after
PATIENT use has been concluded.
An OPERATOR ALARM SYSTEM
...