IEC 60601-1-8:2006/Amd 1:2012
(Amendment)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 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 — Amendment 1
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 1
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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
IEC 60601-1-8:2006/A1:2012
---------------------- Page: 1 ----------------------
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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.
---------------------- Page: 3 ----------------------
– 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.
---------------------- Page: 4 ----------------------
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>
---------------------- Page: 5 ----------------------
– 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.
---------------------- Page: 6 ----------------------
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:
---------------------- Page: 7 ----------------------
– 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:
---------------------- Page: 8 ----------------------
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:
---------------------- Page: 9 ----------------------
– 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:
---------------------- Page: 10 ----------------------
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 duration.
ACKNOWLEDGED shall not inactivate the 1 m visual ALARM SIGNALS specified in 6.3.2.2.2.
ACKNOWLEDGED may inactivate some or all of the 4 m visual ALARM SIGNALS specified in
6.3.2.2.1.
ACKNOWLEDGED may cause the DE-ESCALATION of the ALARM CONDITION priority, including DE-
ESCALATION of the ALARM SIGNALS of a LOW PRIORITY ALARM CONDITION into an INFORMATION
SIGNAL.
Compliance is checked by inspection and functional testing.
6.8.3 * Global indefinite ALARM SIGNAL inactivation states
Replace existing Note 1 with the following:
NOTE 1 For the purposes of this standard, a global ALARM OFF or AUDIO OFF ALARM SIGNAL inactivation state can
affect all ALARM CONDITIONS or all PHYSIOLOGICAL ALARM CONDITIONS in an ALARM SYSTEM.
---------------------- Page: 11 ----------------------
– 10 – 60601-1-8 Amend. 1 © IEC:2012
6.8.4 * Termination of inactivation of ALARM SIGNALS
Replace the existing text of the subclause with the following:
Means shall be provided for the OPERATOR to terminate any ALARM SIGNAL inactivation state.
An ALARM SIGNAL inactivation state may terminate automatically, ALARM CONDITION by ALARM
CONDITION, when the affected ALARM CONDITION no longer exists.
EXAMPLE 1 A non-latching PHYSIOLOGICAL ALARM CONDITION automatically terminates when the monitored
parameter returns within its ALARM LIMITS.
EXAMPLE 2 When an ALARM CONDITION has been ACKNOWLEDGED, the resulting state automatically terminates
when the underlying ALARM CONDITION no longer exists.
When an ALARM SIGNAL inactivation state is terminated, the ALARM SYSTEM shall re-evaluate
the need for ALARM CONDITIONS and generate ALARM SIGNALS if appropriate.
Compliance is checked by functional testing.
6.8.5 * Indication and access
Replace the existing first sentence of the first paragraph with the following:
The ALARM SIGNAL inactivation states AUDIO PAUSED, ALARM PAUSED, AUDIO OFF, ALARM OFF and
ACKNOWLEDGED shall be visually indicated (marked) with the appropriate symbol referenced in
Table 5.
Replace the existing third and fourth paragraphs with the following:
The duration of AUDIO PAUSED, ALARM PAUSED or a timed ACKNOWLEDGED, if provided, shall be
disclosed in the instructions for use.
If the AUDIO PAUSED, ALARM PAUSED or a timed ACKNOWLEDGED interval is OPERATOR adjustable,
means to adjust the maximum interval shall only be provided to the RESPONSIBLE
ORGANIZATION (see 6.7) and means may be provided for the OPERATOR to adjust the interval up
to the maximum interval.
Table 5 – ALARM SIGNAL inactivation states
Replace the existing ta
...
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