IEC 60601-2-4:2010/AMD1:2018

Amendment 1 - Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

Amendement 1 - Appareils électromédicaux - Partie 2-4: Exigences particulières pour la sécurité de base et les performances essentielles des défibrillateurs cardiaques

General Information

• Status: Published
• Publication Date: 27-Feb-2018
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 19 - TC 62/SC 62D/MT 19
• Current Stage: PPUB - Publication issued
• Start Date: 28-Feb-2018
• Completion Date: 23-Feb-2018

Relations

• Amends: IEC 60601-2-4:2010 - Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
• Effective Date: 05-Sep-2023

Overview

IEC 60601-2-4:2010/AMD1:2018 is an important international amendment to the IEC 60601-2-4 standard, which specifies particular requirements for the basic safety and essential performance of cardiac defibrillators. Published by the International Electrotechnical Commission (IEC), this amendment updates medical electrical equipment standards specifically targeting cardiac defibrillators, emphasizing safety, reliability, and performance concerns.

The document is vital for manufacturers, healthcare providers, and regulatory bodies engaged in the design, production, or certification of cardiac defibrillators. It establishes updated norms to ensure that defibrillators operate safely and effectively in clinical and emergency scenarios, addressing electrical hazards, device function, electrode characteristics, and warning systems.

Key Topics

• Scope Revision: The amendment clarifies the scope exclusions, specifying that implantable defibrillators, remote control defibrillators, and stand-alone cardiac monitors are beyond this standard's coverage. It reinforces the relationship with IEC 60601-2-27 concerning separate ECG monitors and defibrillator electrodes.

• Normative References Update: References to general safety standards like IEC 60601-1 and related collateral standards on electromagnetic compatibility are included, ensuring harmonized technical requirements across medical electrical devices.

• Definitions and Terminology: The amendment updates key terms related to defibrillators, including definitions for electrodes, charging and discharge circuits, external transcutaneous pacers, and battery replacement, facilitating consistent communication across manufacturers and regulatory entities.

• Electrical Safety Enhancements: There are specific requirements regarding protection against electrical hazards:

  • Guidelines for maximum mains voltage and dielectric strength tests for high-voltage circuits.

  • Mandates on creepage distances and air clearances for high-voltage circuits and insulation to prevent electrical shock risk.

  • Special considerations for defibrillators rated for high altitudes (up to 5,000 meters).

• Alarm and Warning Systems: The amendment mandates the inclusion of an audible warning before energy delivery, ensuring operators and bystanders are alerted prior to shocks-an important risk mitigation measure uninterruptible by operators.

• Electrode Requirements and Performance:

  • Updates on electrode impedance specifications at various frequencies ensure reliable electrical contact.

  • Defibrillation recovery parameters to guarantee electrode readiness after shocks.

  • Packaging and shelf life criteria to maintain electrode integrity and usability.

• Battery and Energy Delivery: Clarifications on battery replacement protocols, energy delivery tests for frequent and infrequent use defibrillators, and requirements for rhythm recognition post-CPR intervals.

Applications

IEC 60601-2-4:2010/AMD1:2018 applies primarily to manufacturers and developers of external cardiac defibrillators, including Automated External Defibrillators (AEDs) and manual defibrillators used in hospitals, ambulances, and public access locations. Its practical applications ensure:

• Enhanced patient safety by minimizing risks associated with electrical faults and unintended energy delivery.

• Improved device reliability and performance under varying environmental conditions, including altitude and electromagnetic disturbances.

• Clear audible warnings to reduce operator errors during emergency cardiac resuscitation.

• Standardized electrode performance and durability, contributing to consistent defibrillation efficacy.

This amendment also guides regulatory bodies and testing laboratories in evaluating defibrillator compliance with modern safety and performance expectations.

Related Standards

• IEC 60601-1 (2005) and Amendments: General safety requirements for medical electrical equipment, forming the foundational framework for IEC 60601-2-4’s specialized rules.

• IEC 60601-1-2 (2014): Collateral standard on electromagnetic disturbances and immunity relevant to defibrillator operation in electromagnetic environments.

• IEC 60601-2-27 (2011): Standards governing cardiac monitors, referenced for devices employing separate ECG electrodes.

• ISO 15223-1 (2016): Medical device symbols standard that influences labeling and electrode packaging specifications.

• ANSI/AAMI EC12: Provides guidance on electrode impedance testing relevant to this IEC amendment.

Conclusion

IEC 60601-2-4:2010/AMD1:2018 amendment reinforces critical safety and performance standards for cardiac defibrillators, a key life-saving medical electrical device. It offers updated technical criteria that address device electrical safety, electrode quality, warning systems, and operational reliability. Compliance with this amendment not only enhances patient protection but also supports global harmonization in defibrillator design, testing, and certification.

Professionals in the medical device industry, healthcare institutions, and regulatory authorities should integrate these standards to ensure their defibrillators meet internationally recognized safety and performance benchmarks, ultimately contributing to improved patient outcomes in cardiac emergency care.

Standards Content (Sample)

IEC 60601-2-4 ®
Edition 3.0 2018-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-4: Particular requirements for the basic safety and essential performance
of cardiac defibrillators
Appareils électromédicaux –
Partie 2-4: Exigences particulières pour la sécurité de base et les performances
essentielles des défibrillateurs cardiaques

IEC 60601-2-4:2010-12/AMD1:2018-02(en-fr)

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IEC 60601-2-4 ®
Edition 3.0 2018-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –

Part 2-4: Particular requirements for the basic safety and essential performance

of cardiac defibrillators
Appareils électromédicaux –
Partie 2-4: Exigences particulières pour la sécurité de base et les performances

essentielles des défibrillateurs cardiaques

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.10 ISBN 978-2-8322-5376-2

– 2 – IEC 60601-2-4:2010/AMD1:2018
 IEC 2018
FOREWORD
This amendment has been prepared by subcommittee 62D: Electromedical equipment, of IEC
technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/1549/FDIS 62D/1555/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.
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 website 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.
_____________
201.1.1 * Scope
Replace the fourth existing paragraph by the following new paragraph:
This particular standard does not apply to implantable DEFIBRILLATORs, remote control
DEFIBRILLATORS, or separate stand-alone cardiac monitors (which are standardized by
IEC 60601-2-27:2011 [2] ). Cardiac monitors which use separate ECG monitoring electrodes
are not within the scope of this standard unless they are used as the sole basis for AED
rhythm recognition detection or beat detection for synchronized cardioversion. DEFIBRILLATOR
electrodes as described in 201.108 can also be used for ECG monitoring; however, due to the
larger electrode area, the requirements of IEC 60601-2-27 are not applicable for
DEFIBRILLATOR ELECTRODES.
201.2 Normative references
Replace, in the "Amendment" section, the existing reference IEC 60601-1-2, including its title,
by the following new reference:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
_______________
Numbers in square brackets refer to the bibliography.

 IEC 2018
Replace, in the "Addition" section, the existing reference "ISO 15223-1:2007" by
"ISO 15223-1:2016"
Add, in the "Addition" section, the following new reference:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
201.3 Terms and definitions
Replace the first existing paragraph by the following new paragraph:
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012 apply, except as follows:
201.3.202
Replace the existing Note 2 by the following new note:
NOTE 2 Such ME EQUIPMENT may also include other monitoring or therapeutic functions (e.g. transcutaneous
pacing).
201.3.203
Add, after the definition, the following new note:
NOTE The CHARGING CIRCUITS for defibrillation and pacing functions may be separate or combined.
201.3.204
Replace the existing definition and note by the following new definition and note:
electrode intended to deliver an electrical pulse for the purpose of cardiac defibrillation and
which may also be used to provide transcutaneous pacing and other monitoring functions
NOTE DEFIBRILLATOR ELECTRODES may be internal or external and disposable or reusable.
201.3.206
Add, after the definition, the following new note:
NOTE The DISCHARGE CIRCUITS for defibrillation and pacing functions may be separate or combined.
201.3.209
Replace the existing note by the following new note:
NOTE The energy storage devices for defibrillation and pacing functions may be separate or combined.
Add, after 201.3.220, the following new term and definition:
201.3.221
PACER
EXTERNAL TRANSCUTANEOUS PACEMAKER
optional circuit within the DEFIBRILLATOR intended to stimulate the heart by a series of
electrical pulses via electrodes applied to the PATIENT's skin
201.7.2.103 Disposable defibrillator electrodes
Replace, in item a) of the existing paragraph, the reference "ISO 15223-1:2007" by
"ISO 15223-1:2016".
– 4 – IEC 60601-2-4:2010/AMD1:2018
 IEC 2018
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Add, after 201.8.3, the following new subclause:
201.8.5.3 * MAXIMUM MAINS VOLTAGE
Addition:
Where the MAXIMUM MAINS VOLTAGE has been assigned the value of 250 V, and the derivation
of test voltage from the value of the MAXIMUM MAINS VOLTAGE includes a 110 % multiplier, that
multiplier shall not apply.
201.8.7.1 General requirements
Replace the existing instruction by the following new instruction:
Replacement of b) dash 4 with:
201.8.8.3 * Dielectric strength
Replace, in the "Addition" section, the first existing paragraph by the following new paragraph:
For the DEFIBRILLATOR and PACER high-voltage circuits, between high-voltage parts of opposite
polarity and high-voltage to low-voltage circuits, the following tests shall replace those of the
general standard.
Delete, in the second paragraph in the "Addition" section, the words "during discharging".
Replace, in the fifth paragraph of Test 1, the term "DEFIBRILLATOR" by "DEFIBRILLATOR or
PACER".
Replace, in the seventh paragraph of Test 1, the term "DEFIBRILLATORS" by "DEFIBRILLATORS or
PACERS".
Add, after the last paragraph of the Subclause, the following new paragraph:
For the dielectric tests of the general standard, the WORKING VOLTAGE is determined without
regard to the presence of defibrillation or pacing voltages.
201.8.9.1.5 * ME EQUIPMENT RATED for high altitudes
Replace the existing paragraph by the following new paragraph:
General standard subclause 8.9.1.5 does not apply to DEFIBRILLATORS rated for use at
altitudes up to 5  000 m.
201.8.9.1.101 * DEFIBRILLATOR ELECTRODES, high-voltage circuits and cables
Delete, in the note, the words "but is under consideration for future application".
Replace the existing item b), excluding the compliance statement, by the following new
paragraphs:
b) * Except for components where the adequacy of ratings can be demonstrated (e.g. by
component manufacturers' ratings or by the dielectric strength tests of 201.8.8.3 of this
standard) the CREEPAGE DISTANCES and AIR CLEARANCES of insulation between the
DEFIBRILLATOR or PACER high-voltage circuits and other parts, and between different parts
of the high-voltage circuits, shall be at least 3 mm/kV.

 IEC 2018
This requirement shall also apply to the isolating means between the high-voltage circuit
of the DEFIBRILLATOR or PACER and other PATIENT circuits.
201.12.3 ALARM SYSTEMS
Delete the entire subclause, including 201.12.3.101.
201.12.4 Protection against hazardous output
Add, after 201.12.4.103, the following new subclause:
201.12.4.104 * Audible warnings prior to energy delivery
The DEFIBRILLATOR shall include an audible warning signal that indicates the DEFIBRILLATOR is
preparing to or is about to deliver energy to the PATIENT. The preparing-to or about-to-deliver-
energy-to-the-patient warning shall not be capable of being inhibited by the OPERATOR or
RESPONSIBLE ORGANIZATION. The warning shall occur:
a) for manual DEFIBRILLATORS and AEDs with OPERATOR activated discharge control, when the
discharge control is active;
b) for AEDs with automatic discharge control, at least 5 s prior to energy delivery.
The effectiveness of the audible warnings to mitigate the risk of unintentional energy delivery
OPERATOR or bystander shall be included in the RISK MANAGEMENT FILE.
to the
201.15.4.3.101 * Non-rechargeable battery replacement
Replace the existing title by the following new title:
201.15.4.3.101 * Battery replacement
201.101.1 Requirements for FREQUENT USE, MANUAL DEFIBRILLATORS
Replace, in the third paragraph, "201.7.2.101" by "201.7.2.102".
201.101.4 * Requirements for INFREQUENT USE, AUTOMATED EXTERNAL DEFIBRILLATORS
Replace the existing paragraph before the last by the following new paragraph:
In case of a DEFIBRILLATOR with non-rechargeable batteries, the test is to start with a battery
depleted by the delivery of the number of charge/discharge cycles after which it is specified
as still useable by the MANUFACTURER, or when the ME EQUIPMENT indicates that the battery
needs replacement, whichever comes first.
201.102.3.1 FREQUENT USE AED
Add, after the first paragraph, the following new paragraphs:
If the AED is incapable of meeting one of the above criteria due to the implementation of a
fixed protocol which does not meet the above criteria, select and use the available protocol
that most closely matches one of the provided criteria.
For a FREQUENT USE AED with a pre-programmed energy setting sequence, not changeable by
the OPERATOR or RESPONSIBLE ORGANIZATION, the AED shall be able to deliver 20 defibrillation
discharges at the pre-programmed setting. In case of pre-programmed energy setting
sequence being changeable by the OPERATOR or RESPONSIBLE ORGANIZATION, the AED shall be
able to deliver 20 defibrillation discharges at the maximum energy setting sequence
selectable.
– 6 – IEC 60601-2-4:2010/AMD1:2018
 IEC 2018
201.102.3.2 INFREQUENT USE AED
Add, after the first paragraph, the following new paragraph:
If the AED is incapable of meeting one of the above criteria due to the implementation of a
fixed protocol which does not meet the above criteria, select and use the available protocol
that most closely matches one of the provided criteria.
201.105.1 ECG signal derived via DEFIBRILLATOR ELECTRODES
Add, after the second paragraph, the following new paragraph:
If the AED incorporates a CPR interval after a shock within the pre-programmed defibrillation
sequence, the ECG shall be correctly interpreted by the ECG RHYTHM RECOGNITION DETECTOR
20 s after the minimum CPR interval setting.
201.105.3 ECG signal derived via non-reusable DEFIBRILLATOR ELECTRODES
Add, after the last paragraph, the following new paragraph:
If the AED incorporates a CPR interval after a shock within the pre-programmed defibrillation
sequence, the ECG shall be correctly interpreted by the ECG RHYTHM RECOGNITION DETECTOR
20 s after the minimum CPR interval setting.
201.106 * Disturbance to the MONITOR from charging or internal discharging
Add, after item c) of the third paragraph, the following new paragraph:
If necessary, a capacitor may be added in parallel with the 5 kΩ impedance for tests b) and c)
above such that the device operates within its valid patient impedance range. If used, the
capacitor shall be the minimum value required to achieve a valid patient impedance. The
value of the capacitor and the rationale for the selected value shall be disclosed in the test
report.
201.108.1.1 * AC small signal impedance
Replace the first two existing paragraphs by the following new paragraphs:
The 10 Hz impedance for any of at least 12 electrode pairs connected gel-to-gel, at a level of
impressed current not exceeding 100 microamperes (µA) peak-to-peak, shall not exceed
3 kΩ. The impedance at 30 kHz shall be less than 10 Ω.
Reference: ANSI/AAMI EC12, Section 4.2.2.1 on sample size and failure rate.
Compliance is checked by connecting a pair of electrodes, gel-to-gel, applying a 10 Hz
sinusoidal current of known amplitude not exceeding 100 µA p-p and observing the amplitude
of the resulting voltage across the electrodes. The magnitude of the impedance is the ratio of
the voltage to that of the current. An adequate current generator can be assembled utilizing a
sinusoidal signal (voltage) generator with a resistor in series with the electrode pair. The
value of the resistor should be at least 10 times the value of the electrode impedance.
201.108.1.2 * AC large signal impedance
Replace, in the first paragraph, "3 Ω" by "5 Ω".
Replace, in the second paragraph, "3:50" by "5:50".

 IEC 2018
201.108.1.3 * Combined offset instability and internal noise
Delete the entire subclause.
201.108.1.4 * Defibrillation recovery
Replace the existing paragraph by the following new paragraphs:
The potential of a pair of gel-to-gel electrodes in series with a 50 Ω resistor and subjected to
three shocks at 360 J or maximum energy at 1 min intervals shall not exceed 500 mV at 4 s
and 400 mV at 60 s after the last shock delivery.
When this test is executed after pacing according to 201.108.1.10 c) the potential shall not
exceed 1 000 mV at 4 s and 750 mV at 60 s.
201.108.1.9 * Packaging and shelf life
Replace the existing two paragraphs by the following new paragraphs:
The electrodes shall be manufactured and packaged in such a way that all requirements of
this standard shall be met up to the expiration date and under the storage conditions specified
by the MANUFACTURER. At a minimum, electrodes shall comply with all performance
specifications after storage for 1 year at 35 °C. One-year storage may be simulated by
accelerated testing at higher temperatures. Electrodes shall comply after storage for 24 h at
−30 °C and for 24 h at +65 °C. Electrodes shall be returned to a temperature in the range of
15 °C to 35 °C before the test for compliance is performed. Electrodes shall be tested at both
15 °C and 35 °C.
Compliance is checked by conducting the tests of 201.108.1.1 through 201.108.1.8 at the end
of the specified shelf life and at both 15 °C and 35 °C.
201.108.1.10 * Universal-function electrodes
Replace the last existing paragraph by the following new paragraph:
Compliance is checked by the electrodes meeting these requirements or shall be met by the
disclosure of the performance to each specification: 201.108.1.1 to 201.108.1.4 following an
hour of pacing. Tests shall be conducted immediately after the conclusion of pacing.
201.108.1.11 * Cable length
Replace the first sentence of the first existing paragraph by the following new sentence:
The electrode cables shall have an extended length of at least 2 m for monitor/DEFIBRILLATORs
(e.g. hospital crash cart), and a length of at least 1 m for AEDs.
201.109 * External pacing (U.S.)
Delete, in the title, the words "(U.S.)".
201.109.2.1 Separate pacing pathway
Replace, in item (1) of the second existing paragraph, the reference "Figure US.2" by
"Figure 201.109".
201.109.7 Demand pacing
Add, after the last paragraph of the subclause, the following new paragraphs:

– 8 – IEC 60601-2-4:2010/AMD1:2018
 IEC 2018
Set the pacing rate to its maximum rate. Input ECG with maximum rate +10 %. The unit shall
not have pacing activated. Change the ECG signal rate to maximum rate −10 %. The unit
shall now have pacing activated.
Set the pacing rate to its minimum rate. Input ECG with minimum rate +10 %. The unit shall
not have pacing activated. Change the ECG signal rate to minimum rate −10 %. The unit shall
now have pacing activated.
201.109.8 Pacer lead-off indication
Delete Figure 201.109.
Figure 201.110 – Test circuit for DEFIBRILLATOR overload test of pacing output circuitry
Replace, in the key to the figure, the existing L and R + R values by the following new
L
values:
L = 500 µH
R + R ≤ 10 Ω (R represents the d.c. resistance of inductor L)

L L
202 * Electromagnetic compatibility – Requirements and tests
Replace, in the first sentence, the reference "IEC 60601-1-2:2007" by "IEC 60601-1-2:2014".
202.6.2.3.2 Tests
Add, in the title, an asterisk before the word "Tests".
Replace the first sentence of the existing paragraph before the last by the following new
sentences:
* The DEFIBRILLATOR ELECTRODES are terminated in a simulated PATIENT load (1 kΩ resistor in
parallel with a 1 µF capacitor) and, if necessary, an additional resistor and capacitor parallel
combination in series such that the device operates within its valid patient impedance range.
If used, the additional resistor and capacitor values shall be disclosed in the test report.

 IEC 2018
Annex AA
(informative)
Particular guidance and rationale
Subclause 201.7.2.101 – Concise operating instructions
Add, after the existing paragraph, the following new paragraph:
The monitoring of a PATIENT's ECG is considered relevant where the ECG is needed to either
deliver defibrillation therapy, or to make the determination that the delivery of defibrillation
therapy is needed.
Add, after Subclause 201.8.3, the following new paragraph:
Subclause 201.8.5.3 – MAXIMUM MAINS VOLTAGE
This clarifies the definition in order to retain the test voltage of 250 V, which is considered to
be sufficient for INTERNALLY POWERED ME EQUIPMENT with no means of connection to the
SUPPLY MAINS, or ME EQUIPMENT with a connection to SUPPLY MAINS where the RATED supply
voltage is less than 100 V.
Subclause 201.8.8.3 – Dielectric strength
Replace the first existing paragraph by the following new paragraphs:
Voltage spikes on the SUPPLY MAINS will not appreciably affect the voltage on the energy
storage capacitor; therefore, a moderate test voltage relative to the PEAK WORKING VOLTAGE of
DEFIBRILLATOR or PACER high-voltage circuits was considered to be sufficient. The removal
the
of defibrillation or pacing voltages from the calculation of WORKING VOLTAGE for the tests of the
general standard ensure that all other tests (e.g. between APPLIED PARTS and MAINS PART)
remain in effect, while the tests of this standard are appropriate to ensure the safety of the
defibrillation and pacing circuits.
In the general standard, earthing of the PATIENT is not considered to be a fault condition;
APPLIED PART is connected to earth had to
consequently, the situation where one side of the
be included.
Replace, in the existing subclause, the eight occurrences of the term "DEFIBRILLATOR" by
"DEFIBRILLATOR or PACER".
Subclause 201.8.9.1.5 – ME EQUIPMENT RATED for high altitudes
Delete, in the existing paragraph, the last sentence.
EFIBRILLATOR ELECTRODES, high-voltage circuits and cables
Subclause 201.8.9.1.101 – D
Add, in item b), the following new text:
CHARGING CIRCUITS,
The defibrillation and pacing circuits, typically both comprised of
DISCHARGING CIRCUITS, ENERGY STORAGE DEVICES, etc., may be combined or separate
depending on the architecture of the DEFIBRILLATOR.
For those pacing circuits which utilize the same energy delivery circuits as the
DEFIBRILLATOR, and where the DEFIBRILLATOR WORKING VOLTAGE used in calculating the
CREEPAGE DISTANCES and AIR CLEARANCES is larger than the WORKING VOLTAGE for the
PACER, there is no need to duplicate the testing at the lower voltage.

– 10 – IEC 60601-2-4:2010/AMD1:2018
 IEC 2018
For those pacing circuits which have their own dedicated energy delivery circuits separate
from the DEFIBRILLATOR, the maximum peak voltage present during pacing in NORMAL USE
is used in calculating the CREEPAGE DISTANCES and AIR CLEARANCES. This should include
the worst-case level of superimposed ripple and overshoot that can be present during
NORMAL USE.
In those cases where a component or insulation which is a sub-part of a combined energy
delivery circuit is only exposed to pacing voltages, only pacing voltages should be
considered for that particular component or insulation.
Subclause 201.12.3.101 – Audible warnings prior to energy delivery
Delete the entire subclause.
Add, after Subclause 201.12.4.103, the following new paragraph:
Subclause 201.12.4.104 – Audible warnings prior to energy delivery
The term "warning" was chosen to differentiate from an alarm associated with patient
monitoring.
Adequate OPERATOR warning prior to discharge is important. However, it is possible to charge
safely even though discharge may not be imminent. Because charging may be an internal
"background" function of the device, it is more important to the OPERATOR to be warned of
impending external events, such as energy delivery. Of more relevance to the OPERATOR is
the following.
a) If the DEFIBRILLATOR is manual or semi-automatic, audible warnings are needed when the
DEFIBRILLATOR becomes fully armed and ready to shock. This allows the OPERATOR and
any bystanders to prepare for the shock.
b) If the DEFIBRILLATOR is fully automatic, audible warnings at least 5 s prior to discharge are
needed to allow time to cease touching the PATIENT.
Audible warnings can be provided as voice prompts, audible tones, or both.
It is highly recommended that the audible warnings prior to energy delivery also be
accompanied by a visual indication.
Subclause 201.15.4.3.101 – Non-rechargeable battery replacement
Replace the existing title by the following new title:
Subclause 201.15.4.3.101 – Battery replacement
Subclause 201.108.1.3 – Combined offset instability and internal noise
Delete the entire subclause.
Subclause 201.108.1.9 – Packaging and shelf life
Add, after the last existing paragraph, the following new paragraph:
The operating temperature range for AEDs is typically 0 °C to 50 °C. Near freezing, a pair of
hydrogel electrodes placed gel-to-gel exhibit very high impedances due to their water content.
However, when placed on the chest, they readily equilibrate with body skin temperature
(~33 °C). At the higher temperatures, there is less resistance to ionic flow and the gel-to-gel
hydrogel electrode pair exhibit lower impedances than at room temperature. Again, when
placed on skin, the electrodes' temperature will approach skin temperature. Thus,

 IEC 2018
DEFIBRILLATOR electrodes will operate in a 0 °C to 50 °C space, as long as the body they are
attached to is warm.
Subclause 201.108.1.11 – Cable length
Replace the existing paragraph by the following new paragraphs:
For monitor/DEFIBRILLATORs, to ensure that the user has adequate cable for most purposes,
minimum cable length of 2 m (80 in) was specified for those units requiring cables. Although it
was recognized that a minimum cable of 3 m (10 ft) might be more useful in some
circumstances, it was felt that a 3 m cable would be rather cumbersome for some mobile
applications and hence was not specified as a minimum requirement.
For AEDs, the only essential requirement is that the cables reach from a device on the floor or
bed to the PATIENT's chest. To allow the DEFIBRILLATOR to be placed out of the way of where
the user might perform CPR, and allow for it to be placed on the PATIENT's right (furthest away
from the cardiac apex), one may compute the distance for the largest male patient. Consulting
[7] and using the largest values from Tables 10.1 to 10.17 (which look at different
nationalities), we find that the maximum shoulder height (1 545 mm) minus the maximum hip
height (965 mm) is 580 mm, the maximum shoulder breadth is 445 mm and the maximum
abdominal depth is 375 mm. The distance is the square root of the sum of the squares, which
is equal to 822 mm. Therefore, a minimum cable length of 1 m is appropriate.
Also, note that only medical professionals use coil cords, therefore there need not be a
separate requirement for devices used by lay users.
Add, after Clause 202, the following new paragraph:
Subclause 202.6.2.3.2 – Tests
For some DEFIBRILLATORs, the simulated PATIENT load consisting of a 1 kΩ resistor in parallel
with a 1 µF capacitor is not within the acceptable/specified range to detect a valid PATIENT is
connected. The load showed in Figure AA.1 is proposed and is unique to each device.
1 kΩ 1 µF
C
R
IEC
Figure AA.1 – Simulated PATIENT load
This load retains the part of the load in the IEC/AAMI specification, but adds a parallel RC to
this in series. The values of this load would be provided by the manufacturer on request to
satisfy any PATIENT qualification features within the device. Since the frequencies used to test

– 12 – IEC 60601-2-4:2010/AMD1:2018
 IEC 2018
EMI are in the tens-of-megahertz to gigahertz range, there should be no effect on the test.
The difference in impedance at lower frequencies would be insignificant to either the test or
the device. It is not possible for manufacturers to specify loads that would improve their test
results because the load that is specified by the MANUFACTURER is in series with the current
AAMI/IEC load and any load could only make results worse, not better.

Bibliography
Replace reference [2] by the following new reference:
[2] IEC 60601-2-27:2011, Medical electrical equipment – Part 2-27: Particular
requirements for the basic safety and essential performance of electrocardiographic
monitoring equipment
Add, at the end of the bibliography, the fol
...