kSIST FprEN ISO 14708-2:2019

Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO/FDIS 14708-2:2019)

This document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.
The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance.
This document was designed for bradyarrhythmia pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).
The electrical characteristics of the implantable pulse generator or lead are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies.
Any features of an active implantable medical device intended to treat tachyarrhythmias are covered by ISO 14708-6.
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.

Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 2: Herzschrittmacher (ISO/FDIS 14708-2:2019)

Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 2: Stimulateurs cardiaques (ISO/FDIS 14708-2:2019)

Le présent document spécifie les exigences applicables aux dispositifs médicaux implantables actifs destinés au traitement des bradyarythmies, ainsi qu'aux dispositifs qui fournissent des thérapies de resynchronisation cardiaque.
Les essais spécifiés dans le présent document sont des essais de type, qui sont à réaliser sur des échantillons d'un dispositif pour en prouver la conformité.
Le présent document a été conçu pour les générateurs d'impulsions destinés au traitement des bradyarythmies, équipés de sondes endocardiques ou épicardiques. Au moment de la rédaction de la présente édition, les auteurs ont reconnu l'émergence de technologies sans sonde, pour lesquelles des adaptations de la présente partie seront exigées. Lesdites adaptations sont laissées à la discrétion des fabricants qui ont recours à ces technologies.
Le présent document est aussi applicable à certaines parties et à certains accessoires non implantables des dispositifs (voir Note 1).
Les caractéristiques électriques du générateur d'impulsions implantable ou des sondes sont déterminées, soit par la méthode appropriée décrite dans la présente norme particulière, soit par toute autre méthode dont il a été prouvé qu'elle présentait une exactitude supérieure ou égale à celle de la méthode spécifiée. En cas de contradiction, la méthode décrite dans la présente norme particulière s'applique.
Toutes les fonctionnalités des dispositifs médicaux implantables actifs destinées au traitement des tachyarythmies sont couvertes par l'ISO 14708-6.
NOTE 1 Le dispositif communément appelé dispositif médical implantable actif peut en fait se composer d'un seul dispositif, d'une combinaison de plusieurs dispositifs ou d'une combinaison d'un ou plusieurs dispositifs avec un ou plusieurs accessoires. Il n'est pas exigé que toutes ces parties soient totalement ou partiellement implantables, mais il est nécessaire de spécifier certaines exigences des pièces et accessoires non implantables si elles peuvent avoir une influence sur la sécurité ou les performances du dispositif implantable.
NOTE 2 Dans le présent document, les termes imprimés en italique sont utilisés selon les définitions de l'Article 3. Si un terme défini est utilisé pour qualifier un autre terme, il n'est pas imprimé en italique, sauf si le concept ainsi qualifié est aussi défini.

Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 2. del: Srčni spodbujevalniki (ISO/FDIS 14708-2:2019)

General Information

• Status: Not Published
• Public Enquiry End Date: 26-Jul-2018
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: I11 - Imaginarni 11
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 18-Apr-2019
• Due Date: 06-Jun-2019
• Completion Date: 28-Jun-2019
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: FprEN ISO 14708-2 - Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO/FDIS 14708-2:2019)

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 14708-2:2018
01-julij-2018

9VDGNLLPSODQWDWL]DNLUXUJLMR$NWLYQLPHGLFLQVNLSULSRPRþNL]DYVDGLWHYGHO

6UþQLVSRGEXMHYDOQLNL,62',6

Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers

(ISO/DIS 14708-2:2018)

Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 2: Stimulateurs

cardiaques (ISO/DIS 14708-2:2018)
Ta slovenski standard je istoveten z: prEN ISO 14708-2
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14708-2:2018 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 14708-2:2018
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oSIST prEN ISO 14708-2:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14708-2
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-05-04 2018-07-27
Implants for surgery — Active implantable medical
devices —
Part 2:
Cardiac pacemakers
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 2: Stimulateurs cardiaques
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14708-2:2018(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2018
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ISO 14708-2:201x
22 Contents

23 Foreword .......................................................................................................................................................................... 5

24 Introduction..................................................................................................................................................................... 6

25 1 Scope ............................................................................................................................................................................... 7

26 2 Normative references ............................................................................................................................................... 7

27 3 Terms and definitions .............................................................................................................................................. 8

28 4 Symbols and abbreviated terms ........................................................................................................................ 13

29 5 General requirements for non-implantable parts ...................................................................................... 13

30 6 Measurements of IMPLANTABLE PULSE GENERATOR and LEAD characteristics .......................................... 13

31 7 General arrangement of the packaging ........................................................................................................... 26

32 8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES ......................................................................... 26

33 9 MARKINGS on the SALES PACKAGING ........................................................................................................................ 26

34 10 Construction of the SALES PACKAGING ............................................................................................................... 27

35 11 MARKINGS on the STERILE PACK ............................................................................................................................ 27

36 12 Construction of the NON-REUSABLE PACK .......................................................................................................... 29

37 13 MARKINGS on the ACTIVE IMPLANTABLE MEDICAL DEVICE .................................................................................. 29

38 14 Protection from unintentional biological effects being caused by the ACTIVE IMPLANTABLE

39 MEDICAL DEVICE ............................................................................................................................................................... 30

40 15 Protection from HARM to the patient or user caused by external physical features of the ACTIVE

41 IMPLANTABLE MEDICAL DEVICE ...................................................................................................................................... 30

42 16 Protection from HARM to the patient caused by electricity .................................................................... 30

43 17 Protection from HARM to the patient caused by heat ............................................................................... 32

COPYRIGHT PROTECTED DOCUMENT

44 18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE MEDICAL

© ISO 2018

45 DEVICE ............................................................................................................................................................................... 33

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

46 19 Protection from unintended effects caused by the device..................................................................... 33

below or ISO’s member body in the country of the requester.
ISO copyright office

47 20 Protection of the device from damage caused by external defibrillators ........................................ 34

CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]

48 21 Protection of the device from changes caused by high power electrical fields applied directly

Fax: [phone]
Email: [e-mail]

49 to the patient ................................................................................................................................................................ 35

Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved © ISO 2018 – All rights reserved 3
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22 Contents

23 Foreword .......................................................................................................................................................................... 5

24 Introduction..................................................................................................................................................................... 6

25 1 Scope ............................................................................................................................................................................... 7

26 2 Normative references ............................................................................................................................................... 7

27 3 Terms and definitions .............................................................................................................................................. 8

28 4 Symbols and abbreviated terms ........................................................................................................................ 13

29 5 General requirements for non-implantable parts ...................................................................................... 13

30 6 Measurements of IMPLANTABLE PULSE GENERATOR and LEAD characteristics .......................................... 13

31 7 General arrangement of the packaging ........................................................................................................... 26

32 8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES ......................................................................... 26

33 9 MARKINGS on the SALES PACKAGING ........................................................................................................................ 26

34 10 Construction of the SALES PACKAGING ............................................................................................................... 27

35 11 MARKINGS on the STERILE PACK ............................................................................................................................ 27

36 12 Construction of the NON-REUSABLE PACK .......................................................................................................... 29

37 13 MARKINGS on the ACTIVE IMPLANTABLE MEDICAL DEVICE .................................................................................. 29

38 14 Protection from unintentional biological effects being caused by the ACTIVE IMPLANTABLE

39 MEDICAL DEVICE ............................................................................................................................................................... 30

40 15 Protection from HARM to the patient or user caused by external physical features of the ACTIVE

41 IMPLANTABLE MEDICAL DEVICE ...................................................................................................................................... 30

42 16 Protection from HARM to the patient caused by electricity .................................................................... 30

43 17 Protection from HARM to the patient caused by heat ............................................................................... 32

44 18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE MEDICAL

45 DEVICE ............................................................................................................................................................................... 33

46 19 Protection from unintended effects caused by the device..................................................................... 33

47 20 Protection of the device from damage caused by external defibrillators ........................................ 34

48 21 Protection of the device from changes caused by high power electrical fields applied directly

49 to the patient ................................................................................................................................................................ 35

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50 22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by miscellaneous

51 medical treatments .................................................................................................................................................... 35

52 23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces ................................ 35

53 24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic

54 discharge ........................................................................................................................................................................ 39

55 25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmospheric

56 pressure changes ........................................................................................................................................................ 39

57 26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by temperature

58 changes ........................................................................................................................................................................... 40

59 27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from electromagnetic non-ionizing

60 radiation ........................................................................................................................................................................ 40

61 28 Accompanying documentation ........................................................................................................................ 40

62 Annex AA (informative) Relationship between the fundamental principles in ISO/TR 14283 and

63 the clauses of this International Standard......................................................................................................... 45

64 Annex BB (informative) Relationship between the clauses of ISO 14708-1 and the fundamental

65 principles in Annex A ................................................................................................................................................ 59

66 Annex CC (informative) Rationale ....................................................................................................................... 60

67 Annex DD (informative) Code for describing modes of IMPLANTABLE PULSE GENERATORS ................... 70

68 Annex EE (normative) PULSE forms .................................................................................................................... 74

69 Bibliography ................................................................................................................................................................. 76

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71 Foreword

72 ISO (the International Organization for Standardization) is a worldwide federation of national

73 standards bodies (ISO member bodies). The work of preparing International Standards is normally

74 carried out through ISO technical committees. Each member body interested in a subject for which a

75 technical committee has been established has the right to be represented on that committee.

76 International organizations, governmental and non-governmental, in liaison with ISO, also take part in

77 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all

78 matters of electrotechnical standardization.

79 The procedures used to develop this document and those intended for its further maintenance are

80 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

81 different types of ISO documents should be noted. This document was drafted in accordance with the

82 editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives

83 Attention is drawn to the possibility that some of the elements of this document may be the subject of

84 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

85 any patent rights identified during the development of the document will be in the Introduction and/or

86 on the ISO list of patent declarations received. www.iso.org/patents

87 Any trade name used in this document is information given for the convenience of users and does not

88 constitute an endorsement.

89 ISO 14708-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee

90 SC 6, Active implants.

91 This third edition cancels and replaces the second edition (ISO 14708-2:2012), which has been

92 technically revised.
93 A list of all parts in the ISO 14708 series can be found on the ISO website.

94 NOTE The attention of Member Bodies is drawn to the fact that equipment MANUFACTURERS and testing

95 organizations might need a transitional period following publication of a new, amended, or revised ISO

96 publication in which to make products in accordance with the new requirements and to equip them for

97 conducting new or revised tests. It is the recommendation of the committee that the content of this publication

98 not be adopted for mandatory implementation nationally earlier than three years from the date of publication.

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99 Introduction

100 This document specifies particular requirements for those ACTIVE IMPLANTABLE MEDICAL DEVICES intended

101 to treat bradyarrhythmias (PACEMAKERS), to provide basic assurance of safety to both patients and users.

102 In recent years, other active implantable cardiovascular devices have emerged, most notably devices

103 that perform the function of improving cardiac output by optimizing ventricular synchrony, in addition

104 to performing PACEMAKER functions.

105 Although these devices can deliver an additional therapy with respect to PACEMAKERS, most of their

106 requirements are similar so that, in most cases, the concepts that apply to PACEMAKERS also apply to CRT-

107 P devices, and the appropriate way to test a CRT-P device is similar to the way PACEMAKERS are tested.

108 An implantable cardiac PACEMAKER is essentially a powered electronic device within a sealed,

109 encapsulating enclosure (an IMPLANTABLE PULSE GENERATOR). The device can stimulate heart BEATs by

110 generating electrical impulses which are transmitted to the heart along implanted, insulated conductors

111 with ELECTRODES (LEADS). The PACEMAKER can be adjusted non-invasively by an electronic device, known

112 as a programmer.

113 This document is relevant to all parts of implantable PACEMAKERS, including all ACCESSORIES. Typical

114 examples are IMPLANTABLE PULSE GENERATORS, LEADS, ADAPTORS, programmers and the related software.

115 The requirements of this part of ISO 14708 supplement or modify those of ISO 14708-1, referred to as

116 the General Standard. The requirements of this document take priority over those of ISO 14708-1.

117 Figures or tables that are additional to those of ISO 14708-1 are numbered starting from 101;

118 additional annexes are lettered AA, BB, etc.

119 Although both this document and the Directive 90/385/EEC deal with the same products, the structure

120 and purpose of the two documents are different. Annex AA correlates the requirements of the Directive

121 with the subclauses of ISO 14708-1 and this document. Annex BB provides reference in the other

122 direction, from this document to the Directive. Annex CC is a rationale providing further explanation of

123 the subclauses of this document.

124 Annex DD describes a coding system that may be used to designate bradyarrhythmia pacing modes.

125 Annex EE defines reference points for measurements of PULSE AMPLITUDE and PULSE DURATION, and the

126 form of test signal used to determine SENSITIVITY.
127 All annexes except Annex EE are informative.
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128 Implants for surgery — Active implantable medical devices —
129 Part 2: Cardiac PACEMAKERS
130 1 Scope

131 This document specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES

132 intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.

133 The tests that are specified in this document are type tests, and are to be carried out on samples of a

134 device to show compliance.

135 This document was designed for Bradyarrhythmia PULSE generators used with endocardial or epicardial

136 LEADS. At the time of this edition, the authors recognized the emergence of leadless technologies for

137 which adaptations of this part will be required. Such adaptations are left to the discretion of

138 MANUFACTURERS incorporating these technologies.

139 This document is also applicable to some non-implantable parts and ACCESSORIES of the devices (see

140 NOTE 1).

141 The electrical characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD are determined either by the

142 appropriate method detailed in this particular standard or by any other method demonstrated to have

143 an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this

144 particular standard applies.

145 Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by

146 ISO 14708-6.

147 NOTE 1 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE can in fact be a single

148 device, a combination of devices, or a combination of a device or devices and one or more ACCESSORIES. Not all of

149 these parts are required to be either partially or totally implantable, but there is a need to specify some

150 requirements of non-implantable parts and ACCESSORIES if they could affect the safety or performance of the

151 implantable device.

152 NOTE 2 In this document, terms printed in small capital letters are used as defined in Clause 3. Where a defined

153 term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified

154 is also defined.
155 2 Normative references

156 The following documents, in whole or in part, are normatively referenced in this document and are

157 indispensable for its application. For dated references, only the edition cited applies. For undated

158 references, the latest edition of the referenced document (including any amendments) applies.

159 ISO 5841-3:2013, Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for

160 implantable pacemakers

161 ISO 8601:2004, Data elements and interchange formats — Information interchange — Representation of

162 dates and times
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163 ISO 11318:2002, Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators —

164 Dimensions and test requirements

165 ISO 14117:— , Active implantable medical devices — Electromagnetic compatibility — EMC test

166 protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac

167 resynchronization devices, Second Edition

168 ISO 14708-1:2014, Implants for surgery — Active implantable medical devices — Part 1: General

169 requirements for safety, marking and for information to be provided by the manufacturer

170 ISO 27186:2010, Active implantable medical devices - Four-pole connector system for implantable cardiac

171 rhythm management devices - Dimensional and test requirements
172 3 Terms and definitions

173 For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following

174 apply.

175 ISO and IEC maintain terminological databases for use in standardization at the following addresses:

176  ISO Online browsing platform: available at http://www.iso.org/obp
177  IEC Electropedia: available at http://www.electropedia.org/
178 3.101
179 accessories

180 articles which, while not being a device, are intended specifically by the MANUFACTURER to be used

181 together with a device in accordance with the use of the device intended by the device MANUFACTURER

182 3.102
183 adaptor

184 special connector used between an otherwise incompatible active IMPLANTABLE PULSE GENERATOR and a

185 LEAD
186 3.103
187 pacemaker

188 ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias, comprising an IMPLANTABLE

189 PULSE GENERATOR and LEAD(S)
190 3.104
191 implantable pulse generator

192 part of the PACEMAKER, including the power supply and electronic circuit that produces an electrical

193 output
194 3.105
195 sensor

196 part of a PACEMAKER that is designed to detect signals for the purpose of RATE MODULATION or other

197 control purposes
In development.
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198 3.106
199 dual-chamber
200 condition of relating both to the atrium and ventricle
201 3.107
202 implantable cardiac resynchronization therapy pacing device
203 CRT-P

204 ACTIVE IMPLANTABLE MEDICAL DEVICE intended to provide improved ventricular activation to optimize

205 cardiac output, comprising an IMPLANTABLE PULSE GENERATOR and LEADS

206 [SOURCE: ISO 14117:201x, 3.3, modified – PULSE GENERATOR substituted for “DUT”]

207 3.108
208 sensitivity

209 minimum signal required to control consistently the function of the IMPLANTABLE PULSE GENERATOR

210 3.109
211 electrode

212 electrically conducting part (usually the termination of a LEAD), which is designed to form an interface

213 with body tissue or body fluid
214 3.110
215 bipolar lead
216 LEAD with two ELECTRODES, electrically isolated from each other
217 3.111
218 unipolar lead
219 LEAD with one ELECTRODE
220 3.112
221 endocardial lead

222 LEAD with an ELECTRODE designed to make contact with the endocardium, or inner surface of the heart

223 3.113
224 epicardial lead

225 LEAD with an ELECTRODE designed to make contact with the epicardium, or outer surface of the heart

226 3.114
227 transvenous
228 approach to the heart through the venous system
229 3.115
230 insertion diameter

231 LEAD minimum bore of a rigid cylindrical tube into which the LEAD (not including the connector) can be

232 inserted
233 3.117
234 lead pacing impedance
235 Z

236 impedance that is formed by the ratio of a voltage PULSE to the resulting current

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237 Note 1 to entry: The impedance is composed of the ELECTRODE to tissue interface and the LEAD impedance.

238 3.119
239 model designation

240 name and/or a combination of letters and numbers used by a MANUFACTURER to distinguish, by function

241 or type, one device from another
242 3.120
243 serial number

244 unique combination of letters and/or numbers, selected by the MANUFACTURER, intended to distinguish a

245 device from other devices with the same MODEL DESIGNATION
246 3.121
247 beat
248 ordered spontaneous or paced activity of the heart
249 3.122
250 pulse

251 electrical output of an IMPLANTABLE PULSE GENERATOR intended to stimulate the myocardium

252 3.123
253 pulse amplitude
254 amplitude of the PULSE

255 Note 1 to entry: The PULSE AMPLITUDE is measured according to the procedure in 6.1.2

256 3.124
257 pulse duration
258 duration of the PULSE

259 Note 1 to entry: The PULSE DURATION is measured according to the procedure in 6.1.2

260 3.125
261 pulse interval
262 interval between equivalent points of two consecutive PULSES

263 Note 1 to entry: The PULSE INTERVAL is measured according to the procedure in 6.1.2

264
265 3.126
266 basic pulse interval
267 PULSE INTERVAL in absence of sensed cardiac or other electrical influence
268 3.127
269 pulse rate
270 number of PULSES per minute
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271 Note 1 to entry: The PULSE RATE is measured according to the procedure in 6.1.2

272
273 3.128
274 basic rate

275 PULSE RATE of an IMPLANTABLE PULSE GENERATOR, either atrial or ventricular, unmodified by sensed cardiac

276 or other electrical influence
277 3.129
278 atrioventricular interval
279 AV interval

280 delay between an atrial PULSE or the sensing of an atrial depolarization and the subsequent ventricular

281 PULSE or the sensing of a ventricular depolarization

282 Note 1 to entry: The AV INTERVAL is measured according to the procedure in 6.1.8

283
284 3.130
285 escape interval

286 time elapsing between the sensing of a spontaneous BEAT and the succeeding non-triggered PULSE of an

287 IMPLANTABLE PULSE GENERATOR

288 Note 1 to entry: The ESCAPE INTERVAL is measured according to the procedure in 6.1.5

289
290 3.131
291 hysteresis

292 characteristic of an IMPLANTABLE PULSE GENERATOR defined by the difference between the ESCAPE INTERVAL

293 and the BASIC PULSE INTERVAL

294 Note 1 to entry: The ESCAPE INTERVAL is normally longer than the BASIC PULSE INTERVAL; this is “positive” HYSTERESIS.

295 3.132
296 interference pulse rate

297 PULSE RATE with which the IMPLANTABLE PULSE GENERATOR responds when it senses electrical activity that

298 it recognizes as interference
299 3.133
300 maximum tracking rate

301 maximum PULSE RATE at which the IMPLANTABLE PULSE GENERATOR will respond on a 1:1 basis to a

302 triggering signal
303 3.134
304 rate modulation

305 altering of the PULSE INTERVAL as a function of a control parameter other than a sensed BEAT

306 3.135
307 refractory period

308 period of time during which atrial or ventricular PACEMAKER timing is unaffected by sensed spontaneous

309 depolarizations, although sensing is not completely disabled
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