IEC 60601-2-31:1994/AMD1:1998

Amendment 1 - Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source

General Information

• Status: Published
• Publication Date: 31-Dec-1997
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 26-Mar-2008

Relations

• Revised: IEC 60601-2-31:2008 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-31
AMENDMENT 1
1998-01
Amendment 1
Medical electrical equipment –
Part 2-31:
Particular requirements for the safety of external
cardiac pacemakers with internal power source
Amendement 1
Appareils électromédicaux –
Partie 2-31:
Règles particulières de sécurité des stimulateurs cardiaques
externes à source d’énergie interne

 IEC 1998 Droits de reproduction réservés  Copyright - all rights reserved
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http: //www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
PRICE CODE H
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue

– 2 – 60601-2-31 Amend. 1 © IEC:1998(E)

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/252/FDIS 62D/269/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.
A bilingual version of this amendment may be issued at a later date.
–––––––––
Page 9
INTRODUCTION
Replace the text of the first paragraph by the following:
This Particular Standard concerns the safety of PACEMAKERS. The relationship of this Particular
Standard with IEC 60601-1 (including its amendments) and the Collateral Standards is
explained in 1.3.
Replace the text of the fourth paragraph by the following:
PACEMAKERS differ in the various ways in which they maintain and monitor cardiac activity in
different circumstances. The simplest model stimulates the atrium or ventricle independently of
the cardiac activity; others detect atrial or ventricular activity and stimulate the atrium or
ventricle as and when this is necessary; others, more complex, detect the spontaneous heart
activity and stimulate appropriately the atrium and/or the ventricle. Certain PACEMAKERS work
on preset frequency values, amplitudes and impulse duration. Others can have several values
for parameters.
Delete the sixth paragraph.
Page 11
1.3 Particular standards
Replace the text of the first two paragraphs by the following:
Addition:
This Particular Standard amends and supplements a set of IEC publications, hereinafter
referred to as “General Standard”, consisting of IEC 60601-1:1988, Medical electrical
equipment – Part 1: General requirements for safety, amendment 1, amendment 2;
IEC 60601-1-1:1992, Medial electrical equipment – Part 1: General requirements for safety,
1. Collateral Standard: Safety requirements for medical electrical systems, amendment 1;
IEC 60601-1-2:1993, Medical electrical equipment – Part 1: General requirements for safety,
2. Collateral Standard: Electromagnetic compatibility – Requirements and tests, and
IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety, 4.
Collateral Standard: Programmable electronic medical systems.

60601-2-31 Amend. 1 © IEC:1998(E) – 3 –

For brevity, IEC 60601-1 is referred to in this Particular Standards either as the “General

Standard” or as the “General Requirement(s)”, and IEC 60601-1-1, IEC 60601-1-2 and

IEC 60601-1-4 as the “Collateral Standards”.

The term “this Standard” covers this Particular Standard, used together with the General

Standard and Collateral Standards.

Page 13
2 Terminology and definitions

Replace the text of 2.1.102 by the following:
2.1.102
MAXIMUM TRACKING RATE
maximum ventricular pacing rate in response to sensed atrial activity
Page 15
Replace the text of 2.1.105 by the following:
2.1.105
POST-VENTRICULAR ATRIAL REFRACTOR PERIOD (PVARP)
period after a ventricular event (whether sensed or paced), during which synchronous
ventricular pacing is disabled, regardless of any atrial event
6 Identification, marking and documents
6.8 Accompanying documents
6.8.2 Instructions for use
Add, on page 17, the following:
a)* Replacement:
Replace the text of the third dash by the following:

– Instructions for use shall include warnings regarding potential changes in the behaviour of
PULSE GENERATOR
the caused by electromagnetic or other interference sources (e.g.
communication transmitters in hospitals, emergency transport vehicles, cellular telephones,
etc.) and the effects of therapeutic and diagnostic energy sources (e.g. external
cardioversion, diathermy, TENS devices, high-frequency surgical equipment, magnetic
resonance imaging or similar sources) on the PULSE GENERATOR. This shall include advice
PULSE GENERATOR
on recognizing when the behaviour of the is being influenced by external
interference sources and steps to be taken to avoid such interference.

– 4 – 60601-2-31 Amend. 1 © IEC:1998(E)

Page 17
aa) Supplementary instructions for use

3)* Replace the text of the fifth indent by the following:

– sensing amplifier blanking period(s) (if a sensing function is provided);

6)* Replace the existing text by the following:

6) Not used.
Page 21
12)* Replace the text of the fourth indent by the following:
– inspection of the NON-IMPLANTABLE PULSE GENERATOR and PATIENT CABLE for signs of
physical damage or contamination, in particular damage or contamination that may have a
detrimental effect on the electrical isolation properties of the EQUIPMENT;
Add new items 13) and 14) as follows:
13)* A warning that, before handling the EXTERNAL PULSE GENERATOR, the PATIENT CABLE or
indwelling LEADS, steps should be taken to equalize the electrostatic potential between the
USER and the PATIENT, for example by touching the PATIENT at a site remote from the pacing
LEAD.
14)* A caution that, when clinically indicated, supplemental monitoring of the PATIENT should
be considered.
Page 25
36* Electromagnetic compatibility
Replace the text of the first two paragraphs by the following:

This clause of the General Standard applies, except as follows:
36.202.1* ELECTROSTATIC DISCHARGE
Replacement:
Construction of the EQUIPMENT shall ensure a sufficient degree of protection against SAFETY
HAZARDS caused by repeated exposure to ELECTROSTATIC DISCHARGE.
Replace the last sentence in the third paragraph of the compliance test by the following:
No inappropriate delivery of energy to the APPLIED PART shall occur at any severity level
specified in table 102.
60601-2-31 Amend. 1 © IEC:1998(E) – 5 –

Page 33
51 Protection against hazardous output

Add t
...