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

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

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This standard applies to PATIENT CABLES as defined in 201.3. 109. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

Medizinische elektrische Geräte - Teil 2-31: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von externen Schrittmachern mit interner Stromversorgung

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

Medicinska električna oprema - 2-31. del: Posebne zahteve za osnovno varnost in bistvene lastnosti zunanjih srčnih spodbujevalnikov z vgrajenim napajalnim virom

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ZUNANJIH SRČNIH SPODBUJEVALNIKOV z VGRAJENIM NAPAJALNIM VIROM, v nadaljevanju ME OPREMA. Ta mednarodni standard velja za KABLE BOLNIKOV, kot je opredeljeno v točki 201.3.109. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME v okviru uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda.

General Information

• Status: Withdrawn
• Publication Date: 11-Aug-2011
• Withdrawal Date: 02-Aug-2014
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 03-Apr-2023
• Completion Date: 03-Apr-2023
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-31:2008/A1:2011 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Relations

• Replaced By: EN IEC 60601-2-31:2020 - 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: 07-Apr-2020
• Amends: EN 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: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2011
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL]XQDQMLKVUþQLKVSRGEXMHYDOQLNRY]YJUDMHQLPQDSDMDOQLPYLURP
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and
essential performance of external cardiac pacemakers with internal power source
Medizinische elektrische Geräte - Teil 2-31: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von externen Schrittmachern mit
interner Stromversorgung
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
Ta slovenski standard je istoveten z: EN 60601-2-31:2008/A1:2011
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-31/A1
NORME EUROPÉENNE
August 2011
EUROPÄISCHE NORM
ICS 11.040.01
English version
Medical electrical equipment -
Part 2-31: Particular requirements for the basic safety and essential
performance of external cardiac pacemakers with internal power source
(IEC 60601-2-31:2008/A1:2011)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-31: Exigences particulières pour Teil 2-31: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des stimulateurs cardiaques Leistungsmerkmale von externen
externes à source d'énergie interne Schrittmachern mit interner
(CEI 60601-2-31:2008/A1:2011) Stromversorgung
(IEC 60601-2-31:2008/A1:2011)
This amendment A1 modifies the European Standard EN 60601-2-31:2008; it was approved by CENELEC on
2011-08-03. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This amendment exists in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CENELEC member into its own language and notified to the
Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-31:2008/A1:2011 E

Foreword
The text of document 62D/918/FDIS, future amendment 1 to IEC 60601-2-31:2008, prepared by SC 62D,
Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as amendment A1 to EN 60601-2-31:2008
on 2011-08-03.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the amendment has to be
implemented at national level by publication of
an identical national standard or by endorsement (dop) 2012-05-03
– latest date by which the national standards conflicting
with the amendment have to be withdrawn (dow) 2014-08-03
__________
Endorsement notice
The text of amendment 1:2011 to the International Standard IEC 60601-2-31:2008 was approved by
CENELEC as an amendment to the European Standard without any modification.
__________
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

– 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.
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 GE
...