SIST EN 60601-1-8:2008/A1:2014

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

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in
ME EQUIPMENT and ME SYSTEMS. It also provides guidance for the application of ALARM SYSTEMS.

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 elektrischen Systemen

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

Medicinska električna oprema - 1-8. del: Splošne zahteve za osnovno varnost in bistvene tehnične lastnosti - Spremljevalni standard: Splošne zahteve, preskušanje in napotki za alarmne sisteme v medicinski električni opremi in medicinskih električnih sistemih - Dopolnilo A1 (IEC 60601-1-8:2006/A1:2012)

General Information

• Status: Published
• Publication Date: 02-Jan-2014
• 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: 16-Dec-2013
• Due Date: 20-Feb-2014
• Completion Date: 03-Jan-2014
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60601-1-8:2007/A1:2013 - 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

Relations

• Corrected By: SIST EN 60601-1-8:2008/A1:2014/AC:2014 - 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
• Effective Date: 24-Dec-2013
• Amends: SIST EN 60601-1-8:2008 - 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
• Effective Date: 29-Jan-2023
• Corrected By: SIST EN 60601-1-8:2008/A1:2014/AC:2014 - 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
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-8:2008/A1:2014
01-februar-2014
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHWHKQLþQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG6SORãQH]DKWHYH
SUHVNXãDQMHLQQDSRWNL]DDODUPQHVLVWHPHYPHGLFLQVNLHOHNWULþQLRSUHPLLQ
PHGLFLQVNLKHOHNWULþQLKVLVWHPLK'RSROQLOR$,(&$
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
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 elektrischen Systemen
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
Ta slovenski standard je istoveten z: EN 60601-1-8:2007/A1:2013
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1-8:2008/A1:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-1-8:2008/A1:2014

---------------------- Page: 2 ----------------------

SIST EN 60601-1-8:2008/A1:2014

EUROPEAN STANDARD
EN 60601-1-8/A1

NORME EUROPÉENNE
March 2013
EUROPÄISCHE NORM

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/A1:2012)

Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-8: Exigences générales pour la Teil 1-8: Allgemeine Festlegungen für die
sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles - Leistungsmerkmale -
Norme collatérale: Exigences générales, Ergänzungsnorm: Alarmsysteme -
essais et guide pour les systèmes Allgemeine Festlegungen, Prüfungen und
d'alarme des appareils et des systèmes Richtlinien für Alarmsysteme in
électromédicaux medizinischen elektrischen Geräten und in
(CEI 60601-1-8:2006/A1:2012) medizinischen elektrischen Systemen
(IEC 60601-1-8:2006/A1:2012)


This amendment A1 modifies the European Standard EN 60601-1-8:2007; it was approved by CENELEC on
2013-01-02. 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, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels


© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-8:2007/A1:2013 E

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SIST EN 60601-1-8:2008/A1:2014
EN 60601-1-8:2007/A1:2013 - 2 -
Foreword
The text of document 62A/824/FDIS, future edition 1 of IEC 60601-1-8:2006/A1, prepared by SC 62A,
"Common aspects of electrical equipment used in medical practice", of IEC/TC 62, "Electrical equipment
in medical practice" and ISO SC 3, "Lung ventilators and related devices" of ISO/TC 121, "Anaesthetic
and respiratory equipment" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 60601-1-8:2007/A1:2013.

The following dates are fixed:
(dop) 2013-10-02
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2016-01-02
• latest date by which the national
standards conflicting with the

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 [and/or CEN] shall not be held responsible for identifying any or all such patent
rights.
Endorsement notice
The text of the International Standard IEC 60601-1-8:2006/A1:2012 was approved by CENELEC as a
European Standard without any modification.

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SIST EN 60601-1-8:2008/A1:2014
- 3 - EN 60601-1-8:2007/A1:2013
Replace the Annex ZA of EN 60601-1-8:2007 by the following:

Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.

Publication Year Title EN/HD Year

IEC 60417 Data- Graphical symbols for use on equipment - -
base


IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
+ corr. December 2006 Part 1: General requirements for basic safety + corr. March 2010
+ corr. December 2007 and essential performance + A11 2011
+ A1 2012


IEC 61672-1 2002 Electroacoustics - Sound level meters - EN 61672-1 2003
Part 1: Specifications


IEC 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices


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 - -

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SIST EN 60601-1-8:2008/A1:2014

---------------------- Page: 6 ----------------------

SIST EN 60601-1-8:2008/A1:2014



IEC 60601-1-8


Edition 2.0 2012-11




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE




AMENDMENT 1

AMENDEMENT 1





Medical electrical equipment –

Part 1-8: General requirements for basic safety and essential performance –

Collateral standard: General requirements, tests and guidance for alarm systems


in medical electrical equipment and medical electrical systems



Appareils électromédicaux –


Partie 1-8: Exigences générales pour la sécurité de base et les performances

essentielles – Norme collatérale: Exigences générales, essais et guide pour

les systèmes d’alarme des appareils et des systèmes électromédicaux










INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

CODE PRIX U


ICS 11.040.01 ISBN 978-2-83220-442-9



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

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

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SIST EN 60601-1-8:2008/A1:2014
– 2 – 60601-1-8 Amend. 1 © IEC:2012
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 SC 3: Lung ventilators and related devices of
ISO technical committee 121: Anaesthetic and respiratory equipment.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/824/FDIS 62A/837/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 standard has been approved by 19 P-
members out of 21 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.
_____________

INTRODUCTION TO THE AMENDMENT
The second edition of IEC 60601-1-8 was published in 2006. Since its publication, an issue
has been identified with respect to pulse and burst testing. In addition, issues have been
raised by IEC/62D/MT 22, Electromedical diagnostic and patient monitoring equipment, during
implementation of alarm system requirements in particular standards within their scope of
work.
At the Brussels meeting, IEC/SC 62A accepted a proposal, based on ISO/TC 121/SC 3
st
Resolution Orebro 6, to develop the 1 amendment to IEC 60601-1-8:2006 to address the
issues identified above. IEC/SC 62A – ISO/TC 121/SC 3 Joint Working Group 2, Alarms, was
reactivated as a maintenance team to develop this amendment.
Foreword
Add the following note at the end of the Foreword:
NOTE The attention of National Committees 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.

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SIST EN 60601-1-8:2008/A1:2014
60601-1-8 Amend. 1 © IEC:2012 – 3 –
1.2 Object
In the first paragraph, change the print type of the defined terms "basic safety" and "essential
performance" to small caps.
1.3.1 IEC 60601-1
Replace the existing first dash with:
– "the general standard" designates IEC 60601-1 alone (latest edition including any
amendments);
2 Normative references
Replace the introductory paragraph with:
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any
amendments) applies.
Replace the normative references for IEC 60417 and IEC 60601-1 with the following:
IEC 60417, Graphical symbols for use on equipment. Available from: symbols.info/equipment>
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
Delete the normative references for IEC 60601-1-2, and IEC 60601-1-6.
Replace the normative reference to IEC 60651:1979 and its Amendment 1 (1993) and
Amendment 2 (2000) with the following:
IEC 61672-1:2002, Electroacoustics – Sound level meters – Part 1: Specifications
Add the following normative reference:
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
Replace the normative references for ISO 3744:1994 and ISO 7000:1989 with the following:
ISO 3744:2010, Acoustics – Determination of sound power 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. Available from: symbols.info/equipment>

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SIST EN 60601-1-8:2008/A1:2014
– 4 – 60601-1-8 Amend. 1 © IEC:2012
3 Terms and definitions
Replace the existing first paragraph with the following:
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012 and IEC 62366:2007, and the following terms and definitions
apply.
3.1
* ALARM CONDITION
Replace the existing definition with the following:
state of the ALARM SYSTEM when it has determined that a potential or actual HAZARDOUS
SITUATION exists for which OPERATOR awareness or response is required
NOTE 1 An ALARM CONDITION can be invalid, i.e. a FALSE POSITIVE ALARM CONDITION.
NOTE 2 An ALARM CONDITION can be missed, i.e. a FALSE NEGATIVE ALARM CONDITION.
Add the following new definition:
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
NOTE 1 ACKNOWLEDGED only affects ALARM SIGNALS that are active at the time of the OPERATOR action.
NOTE 2 ACKNOWLEDGED can terminate after a predetermined time interval has elapsed.
6 Alarm systems
6.1 ALARM CONDITION
6.1.2 * ALARM CONDITION priority
Replace the existing title and text of this subclause including Table 1 with the following:
6.1.2 * Determination of ALARM CONDITIONS and assignment of priority
For each HAZARDOUS SITUATION where the MANUFACTURER has chosen to use an ALARM SYSTEM
as a means of RISK CONTROL, the MANUFACTURER shall assign an ALARM CONDITION and its
priority using Table 1.
For HAZARDOUS SITUATIONS where the onset of potential HARM is delayed and the potential
result of a failure to respond is discomfort or minor reversible injury, the MANUFACTURER may
determine that no ALARM CONDITION is required. In such cases, the MANUFACTURER may
implement an INFORMATION SIGNAL.
NOTE Not all LOW PRIORITY ALARM CONDITIONS require prompt notification of the OPERATOR. On this basis an
auditory ALARM SIGNAL or repeating auditory ALARM SIGNAL can be omitted, when appropriate, since the OPERATOR is
expected to check the ME EQUIPMENT at intervals. In the event that the OPERATOR does not check the ME EQUIPMENT
in a timely fashion, the ALARM CONDITION should escalate from LOW PRIORITY to MEDIUM PRIORITY or HIGH PRIORITY,
and can additionally increase the sound pressure level of the related auditory ALARM SIGNALS, as appropriate.
The priority of each ALARM CONDITION shall be disclosed in the instructions for use. Priorities
may be identified in groups.
Compliance is checked by inspection of the instructions for use and RISK MANAGEMENT FILE.

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SIST EN 60601-1-8:2008/A1:2014
60601-1-8 Amend. 1 © IEC:2012 – 5 –
Table 1 – Determination of ALARM CONDITIONS and assignment of priorities
a
Potential result of failure Onset of potential HARM
to respond to the cause
b c d
Immediate Prompt Delayed
of ALARM CONDITION
Death or irreversible injury HIGH PRIORITY ALARM HIGH PRIORITY ALARM MEDIUM PRIORITY ALARM
e
CONDITION  CONDITION CONDITION
Reversible injury HIGH PRIORITY ALARM MEDIUM PRIORITY ALARM LOW PRIORITY ALARM
CONDITION CONDITION CONDITION
Discomfort or reversible MEDIUM PRIORITY ALARM LOW PRIORITY ALARM LOW PRIORITY ALARM
minor injury CONDITION CONDITION CONDITION, no ALARM
CONDITION or
INFORMATION SIGNAL
a
Onset of potential HARM refers to when an injury occurs and not to when it is manifested.
b
Having the potential for the event to develop within a period of time not usually sufficient for manual corrective
action.
c
Having the potential for the event to develop within a period of time usually sufficient for manual corrective
action.
d
Having the potential for the event to develop within an unspecified time greater than that given under “prompt”.
e
Where practicable, ME EQUIPMENT with a therapeutic function incorporates automatic safety mechanisms to
prevent immediate death or irreversible injury caused by the ME EQUIPMENT. See also appropriate particular
standards.

6.3.2 * Visual ALARM SIGNALS
6.3.2.2 Characteristics of visual ALARM SIGNALS
Restructure the content of this subclause by creating two new subclauses as follows:
6.3.2.2.1 * 4 m (distant) visual ALARM SIGNALS
Under this subclause place the existing text of 6.3.2.2 through Table 2.
In the second paragraph delete the last sentence reading "Alternatively, this indication may be
generated by some other type of visual display or device".
6.3.2.2.2 1 m (OPERATOR’S POSITION) visual ALARM SIGNALS and INFORMATION SIGNALS
Under this subclause place the remainder of the existing text of 6.3.2.2.
Renumber Notes 4 through 7 as Notes 1 through 4.
In Note 3, replace "IEC 60601-1-6" with "IEC 62366".
Replace the last paragraph before the compliance test with the following:
Visual INFORMATION SIGNALS, if provided, shall be correctly perceived as different from HIGH
PRIORITY or MEDIUM PRIORITY visual ALARM SIGNALS at a distance of 1 m from the ALARM SYSTEM
or from the OPERATOR’S POSITION.
NOTE 5 It is recognized that visual INFORMATION SIGNALS and visual ALARM SIGNALS can sometimes contain
identical or similar information.
6.3.3 * Auditory ALARM SIGNALS
6.3.3.1 * Characteristics of auditory ALARM SIGNALS
Replace the first paragraph, including items a) and b), with the following:

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SIST EN 60601-1-8:2008/A1:2014
– 6 – 60601-1-8 Amend. 1 © IEC:2012
If an ALARM SYSTEM is provided with auditory ALARM SIGNALS:
a) all auditory ALARM SIGNALS shall be priority encoded;
b) of HIGH PRIORITY, the HIGH PRIORITY auditory ALARM SIGNALS 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 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 ALARM SYSTEM shall have at least one set of ALARM SIGNALS that
– meets the requirements of Table 3 and Table 4; or
– is generated by means of different technology (e.g., voice synthesizing of verbal ALARM
SIGNALS) and is VALIDATED (e.g., by clinical or simulated clinical USABILITY testing).
Table 3 – * Characteristics of the BURST of auditory ALARM SIGNALS
Replace the existing fifth row of the table with the following:
Where: x shall be a value between 50 ms and 125 ms,
y shall be a value between 125 ms and 250 ms,
the variation of x and y within a BURST shall not exceed ± 5 %, and
MEDIUM PRIORITY t + y shall be greater than or equal to HIGH PRIORITY t + x.
d d
The INTERBURST INTERVAL (t ) for HIGH PRIORITY auditory ALARM SIGNALS shall not be greater than the INTERBURST
b
INTERVAL for MEDIUM PRIORITY auditory ALARM SIGNALS which shall not be greater than the INTERBURST INTERVAL
for LOW PRIORITY auditory ALARM SIGNALS.
Table 4 – * Characteristics of the PULSE of auditory ALARM SIGNALS
In the fourth row, replace the value "20 %" with "40 %".
Replace the existing sixth row of the table with the following:
NOTE 1 The relative sound pressure level of the harmonic components should be within 15 dB above or below
amplitude at the PULSE FREQUENCY.
NOTE 2 In practice, the RISE TIME should not be less than 10 ms to prevent mechanical speaker noise.
Replace the first paragraph after Figure 1, including items c) through h) and Notes 1 and 2,
with the following:
If the ALARM SYSTEM is additionally provided with other sets of auditory ALARM SIGNALS, the
following shall apply:
e) the other auditory ALARM SIGNALS shall be VALIDATED, e.g., by clinical or simulated clinical
USABILITY testing;
f) means shall be provided to store a set of auditory ALARM SIGNALS in the DEFAULT ALARM
PRESET; and
g) means may be provided to store a set of auditory ALARM SIGNALS in any ALARM PRESET.
NOTE 1 See also Annex D.
NOTE 2 Attention is drawn to IEC 62366.
Replace the compliance paragraph with:

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SIST EN 60601-1-8:2008/A1:2014
60601-1-8 Amend. 1 © IEC:2012 – 7 –
Compliance is checked by inspection and functional testing of the ALARM SYSTEM and
inspection of any relevant VALIDATION documentation. Measure the drive signal of the audio
transducer utilizing an oscilloscope or other suitable instrument to cover the frequencies and
the RISE and FALL TIMES of the waveform. Verify the values of x, y, t , t , t , t and t in Table 3
b r s f d
and Table 4. Alternatively, acoustic measurements in an anechoic chamber are permitted.
Acoustically verify the presence of (f ) and at least 3 additional harmonics in the range of
o
150 Hz to 4 000 Hz in the auditory ALARM SIGNAL at 1 m or the intended OPERATOR’S POSITION.
6.3.3.2 * Volume of auditory ALARM SIGNALS and INFORMATION SIGNALS
Replace the title and the first two paragraphs with the following:
6.3.3.2 * Volume and characteristics of auditory ALARM SIGNALS and INFORMATION SIGNALS
The auditory HIGH PRIORITY and MEDIUM PRIORITY ALARM SIGNAL sound pressure level range
measured in accordance with the method of this subclause shall be disclosed in the
ACCOMPANYING DOCUMENTS.
Replace the steps of the compliance test with the following:
a) Set the ALARM SIGNAL sound pressure level (volume level) to its maximum setting.
b) If the ALARM SYSTEM is provided with a HIGH PRIORITY ALARM CONDITION, simulate a HIGH
PRIORITY ALARM CONDITION.
c) Using a microphone of the sound level meter complying with the requirements of type 1
instruments specified in IEC 61672-1:2002, measure the sound pressure levels
– for STATIONARY and MOBILE ME EQUIPMENT, at least at positions 1, 3, 5, and 7, as
specified in Table F.1 of ISO 3744:2010, in a circular plane with a radius from the
vertical axis of the geometric centre of the ME EQUIPMENT equivalent to a mean
distance from the ME EQUIPMENT surfaces of 1 m and at an altitude of 1,5 m.
– for PORTABLE ME EQUIPMENT, at least at positions 2, 4, 6, 8, 10, and 12 as specified in
Table F.1 of ISO 3744:2010 in a hemisphere with a radius from the geometric centre of
the ME EQUIPMENT of 1 m.
d) The indicated sound pressure level when measuring BURSTS is corrected in accordance
with Clause C.3 of IEC 61672-1:2002 or a test PULSE of continuous duration is used for
purposes of the measurement or a test signal of continuous duration comprised of each
PULSE in the BURST without PULSE spacing (t = 0 s) is used for purposes of the
s
measurement.
e) Calculate the A-weighted sound pressure level averaged over the measurement surface
according to 8.2.2 of ISO 3744:2010.
f) If the ALARM SYSTEM is provided with a MEDIUM PRIORITY ALARM CONDITION, simulate a
MEDIUM PRIORITY ALARM CONDITION and repeat c) to e).
g) If the ALARM SYSTEM is provided with a LOW PRIORITY ALARM CONDITION, simulate a LOW
PRIORITY ALARM CONDITION and repeat c) to e).
h) Set the ALARM SIGNAL sound pressure level (volume level) to its minimum setting.
i) Repeat b) to g).
j) Verify that the A-weighted background level of extraneous noise, including any
INFORMATION SIGNALS, is at least 6 dB below that measured during the tests.
k) Verify that the measured sound pressure level range is in compliance with the values
indicated in the instructions for use.
Add the following new subclause:

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SIST EN 60601-1-8:2008/A1:2014
– 8 – 60601-1-8 Amend. 1 © IEC:2012
6.3.3.3 * OPERATOR-adjustable sound pressure level
If an ALARM SYSTEM is provided with a HIGH PRIORITY ALARM CONDITION and an OPERATOR-
adjustable auditory ALARM SIGNAL sound pressure level, the instructions for use shall include a
warning to the effect that auditory alarm signal sound pressure levels that are less than
ambient levels can impede OPERATOR recognition of ALARM CONDITIONS and the ALARM SYSTEM
shall:
a) provide a restricted means for the RESPONSIBLE ORGANIZATION to configure the minimum
OPERATOR-adjustable auditory ALARM SIGNAL sound pressure level (see 6.7); or
b) provide a visual indication that the current sound pressure level might be inaudible when
the auditory ALARM SIGNAL sound pressure level is below a threshold that is configured:
– by a means restricted to the RESPONSIBLE ORGANIZATION (see 6.7); or
– by the MANUFACTURER.
This condition may be visually indicated (marked) with symbol IEC 60417-5576 (2002-11)
(see Symbol 5 of Table C.1). If this symbol is used as that visual indication, an
INFORMATION SIGNAL or other additional visual indication may be provided to distinguish
this state from AUDIO OFF.
An ALARM SYSTEM may be equipped with a dynamically algorithm-adjusted minimum auditory
ALARM SIGNAL sound pressure level. If equipped, the ALARM SYSTEM shall include a means,
accessible only to the RESPONSIBLE ORGANIZATION (see 6.7) to enable and disable the
algorithm-adjusted minimum auditory ALARM SIGNAL sound pressure level. If equipped, the
instructions for use shall describe the algorithm and the minimum and maximum levels.
EXAMPLE 1 An algorithm that sets the minimum auditory ALARM SIGNAL sound pressure level in response to
current ambient sound pressure levels, time of day, evidence of OPERATOR attendance or other variables.
EXAMPLE 2 An algorithm that escalates unresolved active auditory ALARM SIGNALS by increasing their sound
pressure level over time.
Compliance is checked by inspection.
6.4.2 * Delays to or from a DISTRIBUTED ALARM SYSTEM
In item b), replace "(see 6.11.2.2)" with "(see item 6.11.2.2.1 b))".
6.6.2.1 Indication of OPERATOR-adjustable ALARM LIMIT
Replace the existing first paragraph with the following:
If an OPERATOR-adjustable ALARM LIMIT is provided, the ALARM LIMIT shall be indicated
continuously or by OPERATOR action. The means of control to display the ALARM LIMITS may be
visually indicated (marked) with symbol IEC 60417-5649 (2002-10) (see symbol 10 of Table
C.1), IEC 60417-5650 (2002-10) (see symbol 11 of Table C.1) or IEC 60417-5651 (2002-10)
(see symbol 12 of Table C.1), as appropriate.
6.7 * ALARM SYSTEM security
Replace the existing first paragraph with the following:
Means of restricting access to changing or to the storage of changes shall be described in the
technical description (see 6.3.3.1, 6.3.3.3, 6.5.3.1, 6.5.3.2, 6.5.4.1, 6.8.2 b) and c), 6.8.3 b),
6.8.5, 6.10, and 6.11.2.2.1).
6.8 * ALARM SIGNAL inactivation states
6.8.1 * General
Replace the entire existing text of the subclause with the following:

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SIST EN 60601-1-8:2008/A1:2014
60601-1-8 Amend. 1 © IEC:2012 – 9 –
Means shall be provided for the OPERATOR to inactivate the auditory, or the visual and
auditory, generation of ALARM SIGNALS. Means may be provided to inactivate the generation of
other ALARM SIGNALS. Inactivation may apply to an individual ALARM CONDITION, to a group of
ALARM CONDITIONS, to the entire ALARM SYSTEM or to any part of a DISTRIBUTED ALARM SYSTEM.
The inactivation of the generation of ALARM SIGNALS may be indefinite (i.e., ALARM OFF, AUDIO
OFF) or indeterminate (indefinite ACKNOWLEDGED) or timed (i.e., ALARM PAUSED, AUDIO PAUSED
or timed ACKNOWLEDGED).
Means shall be provided for the OPERATOR to determine the ALARM CONDITIONS for which ALARM
SIGNALS are inactivated.
NOTE 1 A group can be predetermined or not.
EXAMPLE 1 All ventilation ALARM CONDITIONS.
EXAMPLE 2 An ALARM SYSTEM that has not received valid data since it was enabled (e.g. after power-up or before
a PATIENT has been connected).
NOTE 2 Additional requirements regarding global ALARM OFF or AUDIO OFF are found in 6.8.3.
If ALARM SIGNAL inactivation applies to an individual ALARM CONDITION or a group of ALARM
CONDITIONS, the generation of ALARM SIGNALS from other ALARM CONDITIONS shall be
unaffected.
AUDIO PAUSED or AUDIO OFF shall not inactivate the 1 m visual ALARM SIGNALS specified in
6.3.2.2.2.
AUDIO PAUSED or AUDIO OFF may inactivate some or all of the 4 m visual ALARM SIGNALS
specified in 6.3.2.2.1 or may cause DE-ESCALATION of the ALARM CONDITION priority.
NOTE 3 An INTELLIGENT ALARM SYSTEM can use the OPERATOR’S activation of AUDIO PAUSED or AUDIO OFF to cause
DE-ESCALATION or to re-evaluate the need for an ALARM CONDITION.
ACKNOWLEDGED, if provided, shall inactivate the auditory ALARM SIGNALS of currently active
ALARM CONDITIONS and shall not affect the ALARM SIGNALS of inactive ALARM CONDITIONS.
ACKNOWLEDGED shall terminate automatically, ALARM CONDITION by ALARM CONDITION, when the
affected ALARM CONDITION no longer exists. See also 6.8.4.
A timed ACKNOWLEDGED shall terminate after a defined duration. An indefinite ACKNOWLEDGED
shall not terminate after a defined duratio
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