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: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• 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: 23-Feb-2018
• Completion Date: 28-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

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
...