prEN IEC 80601-2-31:2024
(Main)Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
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 Anforderungen an die Basissicherheit einschließlich der wesentlichen Leistungsmerkmale von externen Herzschrittmachern mit geräteeigener 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
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2024
Medicinska električna oprema - 2-31. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti zunanjih srčnih spodbujevalnikov z vgrajenim napajalnim virom
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 Anforderungen an die
Basissicherheit einschließlich der wesentlichen Leistungsmerkmale von externen
Herzschrittmachern mit geräteeigener 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: prEN IEC 80601-2-31:2024
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.
62D/2136/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-31 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-06-28 2024-09-20
SUPERSEDES DOCUMENTS:
62D/2040/CD, 62D/2061A/CC
IEC SC 62D : PARTICULAR MEDICAL EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if any,
in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they
are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries”
clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for
submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).
TITLE:
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential
performance of external cardiac pacemakers with internal power source
PROPOSED STABILITY DATE: 2029
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.
62D/2136/CDV – 2 – IEC CDV 80601-2-31 © IEC 2024
2 CONTENTS
3 FOREWORD . 4
4 INTRODUCTION . 7
5 201.1 Scope, object and related standards . 8
6 201.2 Normative references . 9
7 201.3 * Terms and definitions. 10
8 201.4 General requirements . 12
9 201.5 General requirements for testing ME EQUIPMENT . 12
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
11 201.7 ME EQUIPMENT identification, marking and documents . 12
12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
14 201.10 Protection against unwanted and excessive radiation HAZARDS . 22
15 201.11 Protection against excessive temperatures and other HAZARDS . 22
16 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 22
17 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 26
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 27
19 201.15 Construction of ME EQUIPMENT . 27
20 201.16 ME SYSTEMS . 27
21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 27
22 202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 27
23 Annexes . 29
24 Annex I (xxx) Identification of IMMUNITY pass/fail criteria . 30
25 Annex AA (informative) Particular guidance and rationale . 31
26 Bibliography . 52
27 Index of defined terms used in this particular standard . 53
29 Figure 201.101 – Test waveform V implemented by example RCL circuit using C = 120 µF
test
30 L = 25 µH, RL + R = 1 Ω. 17
31 Figure 201.102 – Example circuit of defibrillation test voltage generator for generating a
32 decaying exponential waveform . 18
33 Figure 201.103 – Test setup for a SINGLE CHAMBER external CARDIAC PACEMAKER . 19
34 Figure 201.104 – Test setup for a DUAL CHAMBER external CARDIAC PACEMAKER . 19
35 Figure 201.105 – Test setup for a triple chamber external CARDIAC PACEMAKER, e.g. bi-
36 ventricular external CARDIAC PACEMAKER . 20
37 Figure 201.106 – Timing sequence . 20
38 Figure 201.107 – Measuring circuit for the PATIENT AUXILIARY CURRENT for ME EQUIPMENT with
39 an INTERNAL ELECTRICAL POWER SOURCE . 21
IEC CDV 80601-2-31 © IEC 2024 – 3 – 62D/2136/CDV
40 Figure 201.108 – Measuring circuit for the MAXIMUM TRACKING RATE . 24
41 Figure 201.109 – Initial oscilloscope display when measuring MAXIMUM TRACKING RATE . 25
42 Figure AA.1 – Simple model of a SINGLE CHAMBER EXTERNAL PACEMAKER during defibrillation 40
43 Figure AA.2 – First proposal for a defib-protection test of SINGLE CHAMBER EXTERNAL PACEMAKER
44 42
45 Figure AA.3 – Circuit for a defibrillation test generator for defibrillation test according to
46 conditions during open heart surgery. 43
47 Figure AA.4 – Defibrillation PULSE generated by the defibrillation test generator from
48 Figure AA.3 . 44
49 Figure AA.5 – Rise times of a defibrillation PULSE according to the circuit proposed in
50 Figure AA.3 . 48
52 Table 201.101 – Colours and meanings of indicators lights for EXTERNAL PACEMAKERS. 14
53 Table 201.102 – ME EQUIPMENT parameters . 23
54 Table 202.101 – Static discharge requirements . 28
55 Table AA.1 – EXTERNAL PACEMAKER HAZARD inventory . 32
56 Table 201.101 from IEC 60601-2-31:2020 – Distributed ESSENTIAL PERFORMANCE requirements
57 34
58 Table AA.2 – PULSE energies calculated for C = 120 µF ± 5 % . 45
59 Table AA.3 – PULSE energies calculated for C = 122 µF ± 5 % . 46
60 Table AA.4 – PULSE energies calculated for C = 126,32 µF ± 5 % . 47
62D/2136/CDV – 4 – IEC CDV 80601-2-31 © IEC 2024
63 INTERNATIONAL ELECTROTECHNICAL COMMISSION
64 ____________
66 MEDICAL ELECTRICAL EQUIPMENT –
68 Part 2-31: Particular requirements for the basic safety and essential performance
69 of external cardiac pacemakers with internal power source
71 FOREWORD
72 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all
73 national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co -
74 operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to
75 other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available
76 Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical
77 committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work.
78 International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation.
79 IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions
80 determined by agreement between the two organizations.
81 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
82 consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC
83 National Committees.
84 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees
85 in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate,
86 IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user.
87 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently
88 to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication
89 and the corresponding national or regional publication shall be clearly indicated in the latter.
90 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment
91 services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by
92 independent certification bodies.
93 6) All users should ensure that they have the latest edition of this publication.
94 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of
95 its technical committees and IEC National Committees for any personal injury, property damage or other damage of any
96 nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the
97 publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
98 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
99 indispensable for the correct application of this publication.
100 9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). IEC
101 takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of
102 the date of publication of this document, IEC [had/had not] received notice of (a) patent(s), which may be required to
103 implement this document. However, implementers are cautioned that this may not represent the latest information, which
104 may be obtained from the patent database available at https://patents.iec.ch. IEC shall not be held responsible for
105 identifying any or all such patent rights.
106 IEC 80601-2-31 has been prepared by a Joint Working Group of IEC subcommittee 62D:
107 Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice,
108 and ISO subcommittee SC6: Active implants, of ISO technical committee 150: Implants for surgery. It
109 is an International Standard.
110 This publication is published as a double logo standard.
111 This first edition of IEC 80601-2-31 cancels and replaces the third edition of IEC 60601-2-31
112 published in 2020. This edition constitutes a technical revision.
113 This edition includes the following significant technical changes with respect to the previous edition:
114 • The requirements regarding essential performance have been simplified;
115 • The allowed colours for indicators have been modified from those specified in the general standard;
IEC CDV 80601-2-31 © IEC 2024 – 5 – 62D/2136/CDV
116 • Requirements for terminal markings have been clarified;
117 • The required instructions for use regarding estimated service time for a fully charged battery have
118 been modified;
119 • The test for saline exposure has been clarified as an additional test;
120 • The requirements related to immunity from ELECTROSTATIC DISCHARGE have been modified;
121 • Additional rationale for all changes.
122 The text of this International Standard is based on the following documents:
Draft Report on voting
62D/XX/FDIS 62D/XX/RVD
124 Full information on the voting for the approval of this International Standard can be found in the report
125 on voting indicated in the above table. In ISO, the standard has been approved by TBD P members
126 out of TBD having cast a vote.
127 This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
128 In this document, the following print types are used:
129 – requirements and definitions: roman type;
130 – test specifications: italic type;
131 – informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative
132 text of tables is also in a smaller type;
133 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
134 SMALL CAPITALS.
135 In referring to the structure of this document, the term
136 – "clause" means one of the seventeen numbered divisions within the table of contents, inclusive
137 of all subdivisions ( e.g., Clause 7 includes subclauses 7.1, 7.2, etc.);
138 – "subclause" means a numbered subdivision of a clause ( e.g., 7.1, 7.2 and 7.2.1 are all subclauses
139 of Clause 7).
140 References to clauses within this document are preceded by the term "Clause" followed by the clause
141 number. References to subclauses within this particular standard are by number only.
142 In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
143 combination of the conditions is true.
144 The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
145 Directives, Part 2. For the purposes of this document, the auxiliary verb:
146 – "shall" means that compliance with a requirement or a test is mandatory for compliance with this
147 document;
148 – "should" means that compliance with a requirement or a test is recommended but is not mandatory
149 for compliance with this document;
150 – "may" is used to describe a permissible way to achieve compliance with a requirement or test.
151 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
152 that there is guidance or rationale related to that item in Annex AA.
153 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
154 equipment, can b found on the IEC website.
62D/2136/CDV – 6 – IEC CDV 80601-2-31 © IEC 2024
155 The committee has decided that the contents of this document will remain unchanged until the stability
156 date indicated on the IEC website under webstore.iec.ch in the data related to the specific document.
157 At this date, the document will be
158 • reconfirmed,
159 • withdrawn, or
160 • revised.
161 NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing organizations
162 may need a transitional period following publication of a new, amended or revised IEC publication in which to make products
163 in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the
164 recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier
165 than 3 years from the date of publication.
IMPORTANT – The "colour inside" logo on the cover page of this document indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
IEC CDV 80601-2-31 © IEC 2024 – 7 – 62D/2136/CDV
169 INTRODUCTION
170 The minimum safety requirements specified in this particular standard are considered to provide for a
171 practical degree of safety in the operation of EXTERNAL PACEMAKERS with an internal power source.
172 Basically, CARDIAC PACEMAKERS treat cardiac arrhythmias. Such arrhythmias reduce cardiac output
173 and can lead to confusion, dizziness, loss of consciousness and death. The objective of pacing is to
174 restore cardiac rhythm and output appropriate to the PATIENT's physiological needs.
175 There are two distinct families of CARDIAC PACEMAKERS, implantable PACEMAKERS and EXTERNAL
176 PACEMAKERS. EXTERNAL PACEMAKERS are used to pace PATIENTS temporarily prior to implanting an
177 implantable PACEMAKER as well as for temporary pacing related to other medical PROCEDURES, e.g.
178 open heart surgery.
179 CARDIAC PACEMAKERS differ in the various ways in which they sense and maintain cardiac activity in
180 different circumstances. The simplest model stimulates the atrium or ventricle independently of the
181 cardiac activity; others detect atrial or ventricular activity and stimulate the atrium or ventricle as and
182 when this is necessary; others, more complex, detect the spontaneous heart activity and stimulate
183 appropriately the atrium and/or the ventricle. Certain PACEMAKERS work on pre-set frequency values,
184 amplitudes and impulse duration. Others can have several values for parameters.
185 Standards for EXTERNAL PACEMAKERS require attention to information which will aid in developing and
186 applying these devices. It is through these aspects of standardization that the central role of clinical
187 experience should be, or has been, acknowledged. The ability to predict how a PACEMAKER will
188 perform in a specific PATIENT based on testing of a device to a set of technical criteria is limited.
189 This particular standard does not take into consideration the specific safety aspects of EXTERNAL
190 PACEMAKERS that are connected to a SUPPLY MAINS while simultaneously connected to the PATIENT.
191 This particular standard amends and supplements IEC 60601-1:2005 and
192 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Medical electrical equipment –
193 Part 1: General requirements for basic safety and essential performanc, hereinafter referred to as the
194 general standard.
195 The requirements are followed by specifications for the relevant tests.
196 Clauses or subclauses for which there are explanatory notes in Annex AA are marked with an asterisk
197 (*).
198 An inventory of the PATIENT's safety posed by EXTERNAL PACEMAKERS and a rationale for the safety
199 requirements contained in this particular standard are given in Annex AA. It is considered that
200 knowledge of the reasons for these requirements will not only facilitate the proper application of
201 this particular standard but will, in due course, expedite any revision necessitated by changes in
202 clinical practice or as a result of developments in technology. However, Annex AA does not form part
203 of the requirements of this document.
204 In accordance with IEC directives concerning standards developed jointly with ISO, the numbering of
205 this particular standard has been changed from IEC 60601 -2-31 to IEC 80601-2-31. This document
206 constitutes the first edition of IEC 80601 -2-31.
62D/2136/CDV – 8 – IEC CDV 80601-2-31 © IEC 2024
209 MEDICAL ELECTRICAL EQUIPMENT –
211 Part 2-31: Particular requirements for the basic safety and essential performance
212 of external cardiac pacemakers with internal power source
216 201.1 Scope, object and related standards
217 Clause 1 of the general standard applies, except as follows:
218 201.1.1 * Scope
219 Replacement:
220 This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL
221 PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME
222 EQUIPMENT.
223 This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as
224 defined in 201.3.206.
225 HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this
226 document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the
227 general standard.
228 NOTE See also 4.2 of the general standard.
229 This document does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered
230 by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected
231 directly or indirectly to a SUPPLY MAINS.
232 This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and
233 antitachycardia ME EQUIPMENT.
234 201.1.2 Object
235 Replacement:
236 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
237 PERFORMANCE requirements for EXTERNAL PACEMAKERS as defined in 201.3.205.
238 201.1.3 Collateral standards
239 Addition:
240 This particular standard refers to those applicable collateral standards that are listed in Clause 2 of
241 the general standard and Clause 201.2 of this particular standard.
242 IEC 60601-1-2:2014 + AMD1:2020 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-9,
243 IEC 60601-1-10, IEC 60601-1-11, and IEC 60601-1-12 do not apply. All other published collateral
244 standards in the IEC 60601-1 series apply as published.
245 201.1.4 Particular standards
246 Replacement:
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
IEC CDV 80601-2-31 © IEC 2024 – 9 – 62D/2136/CDV
247 In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in
248 the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under
249 consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.
250 A requirement of a particular standard takes priority over the general standard.
251 For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 and IEC 60601-:2005/AMD2:2020
252 are referred to in this particular standard as the general standard. Collateral standards are referred to
253 by their document number.
254 The numbering of clauses and subclauses of this particular standard corresponds to that of the
255 general standard with the prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1
256 of the general standard) or applicable collateral standard with the prefix "20x" where x is the final
257 digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses
258 the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this particular standard
259 addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the
260 text of the general standard and applicable collateral standards are specified by the use of the
261 following words:
262 "Replacement" means that the clause or subclause of the general standard or applicable collateral
263 standard is replaced completely by the text of this particular standard.
264 "Addition" means that the text of this particular standard is additional to the requirements of the
265 general standard or applicable collateral standard.
266 "Amendment" means that the clause or subclause of the general standard or applicable collateral
267 standard is amended as indicated by the text of this particular standard.
268 Subclauses, figures or tables which are additional to those of the general standard are numbered
269 starting from 201.101. However, due to the fact that definitions in the general standard are numbered
270 3.1 through 3.154, additional definitions in this document are numbered beginning from 201.3.201.
271 Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
272 Subclauses, figures or tables which are additional to those of a collateral standard are numbered
273 starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203
274 for IEC 60601-1-3, etc.
275 The term "this document" is used to make reference to the general standard, any applicable collateral
276 standards and this particular standard taken together.
277 Where there is no corresponding clause or subclause in this particular standard, the clause or
278 subclause of the general standard or applicable collateral standard, although possibly not relevant,
279 applies without modification; where it is intended that any part of the general standard or applicable
280 collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given
281 in this particular standard.
282 201.2 Normative references
283 NOTE Informative references are listed in the Bibliography.
284 Clause 2 of the general standard applies, except as follows:
285 Replacement:
286 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety
287 and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and
288 tests
289 IEC 60601-1-2:2014/AMD1:2020
290 Addition:
62D/2136/CDV – 10 – IEC CDV 80601-2-31 © IEC 2024
291 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and
292 essential performance
293 IEC 60601-1:2005/AMD1:2012
294 IEC 60601-1:2005/AMD2:2020
295 ISO 14117:2019, Active implantable medical devices – Electromagnetic compatibility – EMC test
296 protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac
297 resynchronization devices
298 ISO 14708-2:2019, Implants for surgery – Active implantable medical devices – Part 2: Cardiac
299 pacemakers
300 201.3 * Terms and definitions
301 For the purposes of this document, the terms and definitions specified in IEC 60601-1:2005 and
302 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, ISO 14117:2019, and ISO 14708-
303 2:2019 and the following apply.
304 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
305 • IEC Electropedia: available at http://www.electropedia.org/
306 • ISO Online browsing platform: available at http://www.iso.org/obp
307 NOTE An Index of defined terms is found beginning on page 53.
308 Addition:
309 201.3.201
310 ACTIVE IMPLANTABLE MEDICAL DEVICE
311 active medical device which is intended to be totally or partially introduced, surgically or medically,
312 into the human body or by medical intervention into a natural orifice, and which is intended to remain
313 in place after the procedure
314 [SOURCE: ISO 14708-1:2014, 3.2, modified – The words "in place" have been added to the definition,
315 and the note to entry has been deleted.]
316 201.3.202
317 BATTERY DEPLETION INDICATOR
318 means of indicating when the battery should be replaced
319 201.3.203
320 CARDIAC PACEMAKER
321 ME EQUIPMENT intended to treat bradyarrhythmias
322 201.3.204
323 DUAL CHAMBER
324 relating to both atrium and ventricle
325 201.3.205
326 EXTERNAL PACEMAKER
327 CARDIAC PACEMAKER consisting of a NON-IMPLANTABLE PULSE GENERATOR and PATIENT CABLE(S) (if used)
328 201.3.206
329 LEAD
330 flexible tube enclosing one or more insulated electrical conductors, intended to transfer electrical
331 energy along its length between the EXTERNAL PACEMAKER and the PATIENT'S heart
332 [SOURCE: ISO 14708-1:2014, 3.13, modified – The words "between the EXTERNAL PACEMAKER and the
333 PATIENT'S heart" have been added to the definition, and the note to entry has been deleted.]
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334 201.3.207
335 MAXIMUM TRACKING RATE
336 maximum PULSE RATE at which the multi-chamber NON-IMPLANTABLE PULSE GENERATOR will respond on a
337 1:1 basis to a sensed atrial signal
338 [SOURCE: ISO 14708-2:2019, 3.30, modified – The word " IMPLANTABLE " has been replaced by "multi-
339 chamber NON-IMPLANTABLE" and the word "triggering" by "sensed atrial".]
340 201.3.208
341 NON-IMPLANTABLE PULSE GENERATOR
342 ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE which is intended for use outside the body
343 and which produces a periodic electrical PULSE intended to stimulate the heart through a LEAD (or
344 combination of a LEAD and PATIENT CABLE)
345 201.3.209
346 PATIENT CABLE
347 cable used to extend the distance between the NON-IMPLANTABLE PULSE GENERATOR and the pacing
348 LEAD
349 201.3.210
350 POST-VENTRICULAR ATRIAL REFRACTORY PERIOD
351 PVARP
352 refractory period in atrial channel after paced or sensed event in ventricular channel , used in DUAL
353 CHAMBER modes
354 Note 1 to entry: This note applies to the French language only.
355 201.3.211
356 PRIMARY BATTERY
357 one or more cells, which are not designed to be electrically recharged, that are fitted with devices
358 necessary for use, for example case, terminals, marking and protective devices
359 [SOURCE: IEC 60050-482:2004 + AMD1:2016 + AMD2:2020, 482-01-04, modified – The word
360 "primary" has been added to the term, and the words "which are not designed to be electrically
361 recharged" have been added to the definition.]
362 201.3.212
363 SINGLE CHAMBER
364 relating to either atrium or ventricle
365 201.3.213
366 BASIC RATE
367 PULSE RATE of a NON-IMPLANTABLE PULSE GENERATOR, either atrial or ventricular, unmodified by sensed
368 cardiac or other electrical influence
369 [SOURCE: ISO 14708-2:2019, 3.26, modified – The words "an implantable" have been replaced by "a
370 NON-IMPLANTABLE".]
371 201.3.214
372 ESCAPE INTERVAL
373 time elapsing between the sensing of a spontaneous BEAT and the succeeding non-triggered PULSE of
374 a NON-IMPLANTABLE PULSE GENERATOR
375 [SOURCE: ISO 14117:2019, 3.128, modified – The words "an implantable" have been replaced by "a
376 NON-IMPLANTABLE".]
377 201.3.215
378 INTERFERENCE PULSE RATE
379 PULSE RATE with which the NON-IMPLANTABLE PULSE GENERATOR responds when it senses electrical
380 activity that it recognizes as interference
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381 [SOURCE: ISO 14117:2019, 3.129, modified – The words "an implantable" have been replaced by
382 "NON-IMPLANTABLE".]
383 201.4 General requirements
384 Clause 4 of the general standard applies, except as follows:
385 201.4.3 Essential performance
386 Additional subclause:
387 201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
388 Pacing is considered as ESSENTIAL PERFORMANCE. During intended use, pacing output shall not be
389 interrupted for a period exceeding two pre-set pacing intervals.
390 201.4.10.1 Source of power for ME EQUIPMENT
391 Replacement:
392 ME EQUIPMENT shall be powered by a PRIMARY BATTERY.
393 Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
394 201.4.10.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS
395 This subclause of the general standard does not apply.
396 201.4.11 * Power input
397 This subclause of the general standard does not apply.
398 201.5 General requirements for testing ME EQUIPMENT
399 Clause 5 of the general standard applies.
400 201.6 Classification of ME EQUIPMENT and ME SYSTEMS
401 Clause 6 of the general standard applies, except as follows:
402 201.6.2 * Protection against electric shock
403 Replacement:
404 ME EQUIPMENT shall be classified as INTERNALLY POWERED ME EQUIPMENT.
405 ME EQUIPMENT shall be recognized as INTERNALLY POWERED only if no external connections to an
406 electrical power source are provided.
407 APPLIED PARTS shall be classified as TYPE CF APPLIED PARTS. APPLIED PARTS shall be classified as
408 DEFIBRILLATION-PROOF APPLIED PARTS.
409 201.7 ME EQUIPMENT identification, marking and documents
410 Clause 7 of the general standard applies, except as follows:
411 201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
412 Additional subclauses:
413 201.7.2.101 ME EQUIPMENT intended for SINGLE CHAMBER application
414 If the ME EQUIPMENT is intended for SINGLE CHAMBER applications, the polarity of the connector
415 terminals (if used) shall be conspicuously marked positive (+) and negative ( –).
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416 201.7.2.102 * ME EQUIPMENT intended for DUAL CHAMBER application
417 If the ME EQUIPMENT is intended for DUAL CHAMBER application, the connector terminals (if used) for
418 each channel shall be marked as follows:
419 a) The polarity of each terminal shall be marked as positive (+) and negative ( –).
420 b) The channels shall be marked as follows:
421 – The terminals associated with the atrial channel shall be marked “A”.
422 – The terminals associated with the ventricular channel shall be marked “V”.
423 A single letter may be used to indicate the channel for a pair of terminals where it is not ambiguous as
424 to which terminals are associated with the channel (e.g. by grouping or colour coding).
425 201.7.2.103 ME EQUIPMENT intended for bi-ventricular application
426 If the ME EQUIPMENT is intended for bi-ventricular application, the connector terminals (if used) for each
427 channel shall be marked as follows:
428 a) The polarity of each terminal shall be marked as positive (+) and negative ( –).
429 b) The channels shall be marked as follows:
430 – The terminals associated with the atrial channel shall be marked “A”.
431 – The terminals associated with the right ventricular channel shall be marked “RV”.
432 – The terminals associated with the left ventricular channel shall be marked “LV”.
433 A single marking using letters may be used to indicate the channel for a pair of terminals where it is
434 not ambiguous as to which terminals are associated with the channel (e.g. by grouping or colour
435 coding).
436 201.7.2.104 Bipolar connectors
437 When bipolar connectors are used, they shall have keyways that prevent inadvertent polarity reversal.
438 201.7.2.105 * Battery compartment
439 The means of access to the battery compartment shall be easily identifiable. The battery compartment
440 shall be clearly and permanently marked with the IEC battery nomenclature, the voltage and type. The
441 battery compartment shall be clearly and permanently marked to show the correct orientation of the
442 battery or batteries.
443 201.7.4 Marking of controls and instruments
444 Additional subclauses:
445 201.7.4.101 * Control or indicator for pacing output
446 If constant current output is used, the control for selecting pacing output or the relevant indicating
447 means shall be marked in terms of current in milliamperes (mA) through a resistive load of 500 Ω ±
448 1 %. If a constant voltage output is used, the pacing output or the relevant indicating means shall be
449 marked in terms of volts (V) across a resistive load of 500 Ω ± 1 %.
450 201.7.4.102 * Control or indicator for PULSE RATE
451 The control for selecting PULSE RATE or the relevant indicating means shall be marked in terms of
452 reciprocal minutes.
453 201.7.4.103 * Control for selecting pacing mode
454 If a means of selecting the pacing mode is provided, the ME EQUIPMENT shall indicate, as well as the
455 mode selected, the possible pacing modes using the codes described in Annex C of ISO 14708-
456 2:2019.
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457 201.7.8.1 * Colours of indicator lights
458 Additional subclause:
459 In the case of indicators specifically required for EXTERNAL PACEMAKERS, the indicated colours and
460 their meanings are permitted as defined in Table 201.101:
461 Table 201.101 – Colours and meanings of indicators lights for EXTERNAL PACEMAKERS
Name On when Indicator light Accompanied by Operator
sound requirement
Battery Depletion Defined in Red (flashing or Optional As described in
Indicator 201.11.8 not flashing) Instructions for
Use
Output Indicator Defined in Yellow or Green Optional As described in
201.15.101 flash per pace Instructions for
pulse Use
Input Indicator Defined in Blue or green Optional As described in
201.15.102 flash per sensed Instructions for
beat Use
463 201.7.9 Accompanying documents
464 201.7.9.2.2 * Warning and safety notices
465 Replacement:
466 The instructions for use shall include all warning and safety notices.
467 General warnings and safety notices should be placed in a specifically identified section of the
468 instructions for use. A warning or safety notice that applies only to a specific instruction or action
469 should precede the instruction to which it applies.
470 The instructions for use shall provide the OPERATOR OR RESPONSIBLE ORGANIZATION with warnings
471 regarding any significant RISKS of reciprocal interference posed by the presence of the ME EQUIPMENT
472 during specific investigations or treatments.
473 The instructions for use shall include the following.
474 a) * Warnings regarding potential changes in the behaviour of the NON-IMPLANTABLE PULSE GENERATOR
475 caused by ELECTROMAGNETIC DISTURBANCE sources (e.g. communication transmitters in hospitals,
476 emergency transport vehicles, cellular telephones, etc.) and the effects of therapeutic and
477 diagnostic energy sources (e.g. external cardioversion, diathermy, transcutaneous electrical nerve
478 stimulators [TENS] devices, high frequency surgical equipment, magnetic resonance imaging or
479 similar sources) on the NON- IMPLANTABLE PULSE GENERATOR. This shall include advice on
480 recognizing when the behaviour of the NON-IMPLANTABLE PULSE GENERATOR is being influenced by
481 external ELECTROMAGNETIC DISTURBANCE or electrical energy sources and steps to be taken to
482 avoid interference.
483 b) * A warning about the danger of inadvertently introducing LEAKAGE CURRENT into the heart if SUPPLY
484 MAINS-operated equipment is connected to the LEAD system.
485 c) * A warning that the PATIENT CABLE shall be connected to the NON-IMPLANTABLE PULSE
486 GENERATOR before the pacing LEADS are connected to the PATIENT CABLE.
487 d) * A warning that when handling indwelling LEADS, the terminal pins or exposed metal are not to be
488 touched nor be allowed to contact electrically conductive or wet surfaces.
489 e) * A warning regarding the HAZARDS of using PRIMARY BATTERIES other than those recommended by
490 the MANUFACTURER (for example, short BATTERY life after the indication of low BATTERY condition,
491 degraded ME EQUIPMENT performance, overall reduced BATTERY life, and erratic or no pacing).
IEC CDV 80601-2-31 © IEC 2024 – 15 – 62D/2136/CDV
492 f) * A warning that, before handling the NON-IMPLANTABLE PULSE GENERATOR, the PATIENT CABLE or
493 indwelling LEADS, steps shall be taken to equalize the electrostatic potential between the user and
494 the PATIENT, for example by touching the PATIENT at a site remote from the pacing LEADS.
495 g) * A caution that, when clinically indicated, supplemental monitoring of the PATIENT should be
496 considered.
497 201.7.9.2.4 * Electrical power source
498 Replacement:
499 The instructions for use shall contain advice on removal of the PRIMARY BATTERY if the ME
500 EQUIPMENT is to be stored or when a long period of disuse is anticipated.
501 The instructions for use shall state the recommended PRIMARY BATTERY specification.
502 The instructions for use shall contain the estimated service time from a fully charged battery, and the
503 operating conditions upon which the estimate is based.
504 The instructions for use shall contain the estimated service time following activation of the BATTERY
505 DEPLETION INDICATOR and the operating conditions upon which the estimate is based.
506 The instructions for use shall contain the information (including a reference to the appropriate PRIMARY
507 BATTERY specified in IEC 60086-2 [1] giving the identity of the PRIMARY BATTERIES to be used.
508 201.7.9.2.5 * ME EQUIPMENT description
509 Addition:
510 The instructions for use shall include the following.
511 a) * A general description, explanation of function available, and a description of each heart/PULSE
512 GENERATOR interaction for each available pacing mode. See Clause C.3 of ISO 14708-2:2019 for a
513 description of pacing modes.
514 b) * The connector configuration, the geometry and/or dimensions of the receiving connectors and
515 instructions for connecting the LEAD(S) or PATIENT CABLE(S) to the NON- IMPLANTABLE PULSE
516 GENERATOR.
517 c) * The electrical characteristics (including tolerances where applicable) with 500 Ω ± 1 % load,
518 u
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