IEC 60601-2-31:2008/AMD1:2011

IEC 60601-2-31

®


Edition 2.0 2011-06



INTERNATIONAL



STANDARD



NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1


Medical electrical equipment –
Part 2-31: Particular requirements for the basic safety and essential performance
of external cardiac pacemakers with internal power source

Appareils électromédicaux –
Partie 2-31: Exigences particulières pour la sécurité de base et les performances
essentielles des stimulateurs cardiaques externes à source d'énergie interne


IEC 60601-2-31:2008/A1:2011

---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 60601-2-31


®


Edition 2.0 2011-06



INTERNATIONAL



STANDARD



NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1


Medical electrical equipment –
Part 2-31: Particular requirements for the basic safety and essential performance
of external cardiac pacemakers with internal power source

Appareils électromédicaux –
Partie 2-31: Exigences particulières pour la sécurité de base et les performances
essentielles des stimulateurs cardiaques externes à source d'énergie interne


INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE PRICE CODE
J
CODE PRIX
ICS 11.040.01 ISBN 978-2-88912-553-1

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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– 2 – 60601-2-31 Amend. 1  IEC:2011



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/918/FDIS 62D/931/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 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• withdrawn,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
The purpose of this amendment is to address comments received during the process of
harmonizing the standard in Europe, update several references to defined terms that were not
printed in SMALL CAPS, and improve terminology usage.

INTRODUCTION
Replace the term "IMPLANTABLE" in the first and third lines of the third paragraph with the

same term in normal case
Replace the defined terms "pacemaker" and "patient" in the fourth line of the fifth paragraph
with the same terms in SMALL CAPS.

201.1.1 Scope
Replace the second paragraph with:
This standard applies to PATIENT CABLES as defined in 201.3.109, but does not apply to LEADS
as defined in 201.3.106.
Delete the third paragraph.

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60601-2-31 Amend. 1  IEC:2011 – 3 –


In the fifth paragraph, replace the defined term "active implantable medical devices" with the

same term in SMALL CAPS.


201.1.2 Object


Replace "AS DEFINED IN" in the second line with the same words in normal case.





Replace definition 201.3.105 with:


201.3.105
EXTERNAL PACEMAKER
CARDIAC PACEMAKER consisting of a NON-IMPLANTABLE PULSE GENERATOR and PATIENT CABLE(S)
(if used)
201.3.106
Replace the defined term "patient's" in the second line with the same term in SMALL CAPS.

Replace definition 201.3.107 with:
201.3. 107
MAXIMUM TRACKING RATE
maximum PULSE RATE at which the NON-IMPLANTABLE PULSE GENERATOR will respond on a 1:1
basis to a triggering signal
[ISO 14708-2:2005, definition 3.3.18 modified]
201.3.108
Replace the defined term "pulse" in the second line of the definition with the same term in
small caps.
201.4.3.101
Replace “PERFORMACNE” with “PERFORMANCE”.


201.4.10.2 Supply mains for ME EQUIPMENT and ME SYSTEMS
Replace the defined term "Supply mains" in the title with the same term in SMALL CAPS.

201.7.9.2.2 * Warning and SAFETY notices
Replace the term "pulse generator" with "NON-IMPLANTABLE PULSE GENERATOR" in three places
in item 201.7.9.2.2 aa).
Replace the term "external pulse generator" with "NON-IMPLANTABLE PULSE GENERATOR" in item
201.7.9.2.2 ff).
Replace the defined terms "patient", "lead", "leakage current", "manufacturer", " non-
implantable pulse generator", "patient cable" and "supply mains" with same terms formatted in
SMALL CAPS in items 201.7.9.2.2 bb), cc), dd), ee), ff) and gg).

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– 4 – 60601-2-31 Amend. 1  IEC:2011


201.7. 9.2.4 * Electrical power source


Replace the defined term "primary battery" in the second paragraph with the same term in

SMALL CAPS.





201.7.9.2.13 Maintenance


Replace the term "EQUIPMENT" in the final dashed item with "ME EQUIPMENT".



201.8.5.5 Defibrillation-proof applied parts
Replace the subclause title with:
201.8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS
201.8.5.5.1
Add Note:
NOTE ANSI/AAMI PC69:2007 is being adopted as ISO 14117.
201.8.7.3 * Allowable values
In the requirement, replace "for both d.c. and a.c." with "for d.c.".
Add note:
NOTE Where the a.c. component of the current is intended to produce a physiological effect, it is therefore
outside the definition of PATIENT AUXILIARY CURRENT.

201.8.7.4.8 Measurement of the PATIENT AUXILIARY CURRENT
Replace test method with the following text:
For measurement of the PATIENT AUXILIARY CURRENT, the ME EQUIPMENT is connected as shown
in Figure 201.101. Each PATIENT CONNECTION is connected to a common bus through a

500 Ω ± 1% load resistor (R ). Using a measuring device (MD) consisting of a DC voltmeter,
L
resolution better than 2 µV, fed through a low pass filter with a time constant of at least 10 s,
measure the average direct voltage across each low resistor. Steady state condition shall be
reached before the measurement is made.
The NON-IMPLANTABLE PULSE GENERATOR shall be set to the nominal settings recommended by
the manufacturer (i.e., the factory recommended settings) but with the PULSE AMPLITUDE and
PULSE DURATION programmed to the highest available settings.
NOTE The low pass filter can be implemented by a four-element RC filter with elements built from 1 MΩ resistors
and 10 µF metalized polypropylene capacitors. The input resistance of the dc voltmeter should be ≥ 400 MΩ.
Figure
Replace the existing Figure 201.101 with the following:

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60601-2-31 Amend. 1  IEC:2011 – 5 –



1



R
4
L



+


7


–

4 R
L
MD
IEC  1373/11

Legend

ME EQUIPMENT ENCLOSURE
1



4 PATIENT CONNECTIONS

INTERNAL ELECTRICAL POWER SOURCE
7
Load resistor
R

L
MD Measuring device (see 201.8.7.4.8)

201.11.6.5 * Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
Replace the requirement with:
The ME EQUIPMENT shall be so constructed that the ingress of liquids (accidental wetting),
shall not result in an unacceptable RISK.


201.12.1.101 * ME EQUIPMENT PARAMETERS
Replace the defined term "pulse" in two places in the fifth paragraph with the same term in
SMALL CAPS.

201.12.4.1 * Intentional exceeding of safety limits
In the requirement, replace the reference to "12.4.103" by "201.12.4.103".:
201.12.4.102 * Protection against a low battery condition
Replace the term "EQUIPMENT" in the first line of the first paragraph with ME EQUIPMENT.

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– 6 – 60601-2-31 Amend. 1  IEC:2011


202.6.2.2 Electrostatic discharge (ESD)


202.6.2.2.1 * Requirements

Replace the defined term "operator" in the fourth dashed item with the same term in SMALL
CAPS.





Annex AA – Particular guidance and rationale


Table AA.1 – EXTERNAL PACEMAKER HAZARD inventory
In column 2, row 18, change 'tampering' to 'maladjustment' as follows:
High rate Fault Rate limit (runaway
protection) 201.12.4.103
Maladjustment Protective means 201.12.4.101
Temporary high rate Protective means 201.12.4.1
Atrial tachyarrhythmia MAXIMUM TRACKING RATE 201.12.4.105
Replace "leakage current" and "patient auxiliary current" in Table AA.1 with same terms in
SMALL CAPS.

AA.2 Rationale for particular clauses and subclauses
Subclause 201.1.1 – Scope
Delete the third bullet.
Replace the defined term "pulse generator" in the second line of the paragraph following the
bulleted list with "NON-IMPLANTABLE PULSE GENERATOR".
Clause 201.3 – Terms and definitions
Delete the last sentence in the last paragraph.
Clause 201.6.2 – Protection against electric shock

Delete the first paragraph.

Subclause 201.7.2.102 – ME EQUIPMENT intended for DUAL CHAMBER application
Replace "INSTRUCTIONS FOR USE" in the third line with the same term in normal case.
Replace the defined term "lead" in the fourth line with same term in SMALL CAPS.
Subclause 201.7.2.104 – Battery compartment
Replace the defined term "operator" in the fifth line with the same term in SMALL CAPS.
Subclause 201.7.4.102 – Control or indicator for pulse rate

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60601-2-31 Amend. 1  IEC:2011 – 7 –


Replace the defined term "pulse rate" in the title with the same term in SMALL CAPS.


Subclause 201.7.4.103 – Control for selecting pacing mode


Replace the defined term "pulse generator" in the first line with "NON-IMPLANTABLE PULSE

GENERATOR".


Subclause 201.7.9.2.2 bb)


Delete the first sentence.


Replace the defined term "lead" in the third line with same term in SMALL CAPS.
Subclause 201.7.9.2.2 cc) and dd)
Replace the term "EQUIPMENT" in the third line with "ME EQUIPMENT".
Subclause 201.7.9.2.2 ff)
Replace the term "EXTERNAL PULSE GENERATOR" in the second line with "NON-IMPLANTABLE
PULSE GENERATOR".
Replace the defined terms "pulse" and "patient" in the seventh line with the same terms in
SMALL CAPS.
Subclause 201.7.9.2.2 gg)
Replace the defined terms "pulse" in the first line with the same terms in SMALL CAPS.
Replace the term "EXTERNAL PULSE GENERATOR" in the second line with "NON-IMPLANTABLE
PULSE GENERATOR".
Replace the term "equipment" in the eighth line with "ME EQUIPMENT".
Subclause 201.7.9.2.4 – Electrical power source
Replace the defined term "risks" in the second line of the second paragraph with the same
term in SMALL CAPS.

Subclause 201.7.9.2.5 aa)
Replace the term "pulse generator" in the first line with "NON-IMPLANTABLE PULSE GENERATOR".
Subclause 201.8.7.4.1 aa)
Replace the defined term "pulse" in two place
...