FprEN ISO 14708-6
(Main)Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO/FDIS 14708-6:2019)
Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO/FDIS 14708-6:2019)
This document specifies requirements that are applicable to implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance.
This document was designed for tachyarrhythmia pulse generators used with either endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial or epicardial leads 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 characteristics of the implantable pulse generator or lead shall be determined by either the appropriate method detailed in this document or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document shall apply.
Any aspect of an active implantable medical device intended to treat bradyarrhythmias or cardiac resynchronization is covered by ISO 14708-2.
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 6: Besondere Festlegungen für aktive implantierbare medizinische Produkte zur Behandlung von Tachyarrhythmie (einschließlich implantierbaren Defibrillatoren) (ISO/FDIS 14708-6:2019)
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 6: Exigences particulières pour les dispositifs médicaux implantables actifs destinés à traiter la tachyarythmie (y compris les défibrillateurs implantables) (ISO/FDIS 14708-6:2019)
Les essais qui sont spécifiés dans l'ISO 14708 sont des essais de type et doivent être effectués sur des échantillons d'un dispositif pour vérifier la conformité.
Le présent document a été conçu pour les générateurs d'impulsions traitant la tachyarythmie utilisés avec des sondes endocardiques ou épicardiques. Au moment de l'élaboration de cette édition, les auteurs ont reconnu l'émergence de nouvelles technologies qui n'utilisent ni de sondes endocardiques ni de sondes épicardiques et pour lesquelles des adaptations de cette partie seront nécessaires. Ces adaptations sont laissées à la discrétion des fabricants qui intègrent ces technologies.
Ce document est également applicable à certaines parties non implantables et aux accessoires des dispositifs (voir Note 1).
Les caractéristiques du générateur d'impulsions implantable ou de la sonde doivent être déterminées soit par la méthode appropriée expliquée dans le présent document, soit par une autre méthode pour laquelle il a été démontré qu'elle possède un degré d'exactitude au moins égal à la méthode indiquée. En cas de désaccord, la méthode expliquée dans le présent document doit être appliquée.
Tout aspect d'un dispositif médical implantable actif destiné au traitement de la bradyarythmie ou de la resynchronisation cardiaque est couvert par l'ISO 14708-2.
NOTE 1 Le dispositif qui est généralement identifié comme un dispositif médical implantable actif peut être en fait un dispositif unique, une combinaison de dispositifs ou une combinaison d'un ou de plusieurs dispositifs et d'un nombre variable d'accessoires. Ces éléments ne sont pas nécessairement tous implantables, en partie ou en totalité, mais il est nécessaire de spécifier certaines exigences pour les parties et accessoires non implantables s'ils peuvent affecter la sécurité ou la performance du dispositif implantable.
NOTE 2 Dans le présent document, les termes écrits en italique sont utilisés conformément aux définitions données à l'Article 3. Lorsqu'un terme défini est utilisé comme qualificatif d'un autre terme, il n'est pas écrit en italique, sauf si le concept ainsi qualifié est également défini.
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 6. del: Posebne zahteve za aktivne vsadljive medicinske pripomočke, namenjene za zdravljenje tahiaritmije (vključuje vsadljive defibrilatorje) (ISO/FDIS 14708-6:2019)
General Information
Standards Content (sample)
SLOVENSKI STANDARD
oSIST prEN ISO 14708-6:2018
01-julij-2018
9VDGNL LPSODQWDWL ]DNLUXUJLMR$NWLYQLPHGLFLQVNLSULSRPRþNL]DYVDGLWHYGHO
3RVHEQH]DKWHYH]DDNWLYQHYVDGOMLYHPHGLFLQVNHSULSRPRþNHQDPHQMHQH]D]GUDYOMHQMHWDKLDULWPLMH YNOMXþXMHYVDGOMLYHGHILEULODWRUMH ,62',6
Implants for surgery - Active implantable medical devices - Part 6: Particularrequirements for active implantable medical devices intended to treat tachyarrhythmia
(including implantable defibrillators) (ISO/DIS 14708-6:2018)Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 6: Exigences
particulières pour les dispositifs médicaux implantables actifs destinés à traiter la
tachyarythmie (y compris les défibrillateurs implantables) (ISO/DIS 14708-6:2018)
Ta slovenski standard je istoveten z: prEN ISO 14708-6ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14708-6:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 14708-6:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14708-6
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 6:
Particular requirements for active implantable medical
devices intended to treat tachyarrhythmia (including
implantable defibrillators)
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 6: Exigences particulières pour les dispositifs médicaux implantables actifs destinés à traiter la
tachyarythmie (y compris les défibrillateurs implantables)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 14708-6:2018(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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oSIST prEN ISO 14708-6:2018
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ISO 14708-6:201x
24 Contents
25 Foreword .......................................................................................................................................................................... 5
26 Introduction..................................................................................................................................................................... 6
27 1 Scope ............................................................................................................................................................................... 7
28 2 Normative references ............................................................................................................................................... 7
29 3 Terms and definitions .............................................................................................................................................. 8
30 4 Symbols and abbreviated terms ........................................................................................................................ 12
31 5 General requirements for non-implantable parts ...................................................................................... 12
32 6 Measurement of IMPLANTABLE PULSE GENERATOR and LEAD characteristics ............................................ 12
33 7 General arrangement of the packaging ........................................................................................................... 15
34 8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES ......................................................................... 15
35 9 MARKINGS on the SALES PACKAGING ........................................................................................................................ 16
36 10 Construction of the SALES PACKAGING ............................................................................................................... 17
37 11 MARKINGS on the STERILE PACK ............................................................................................................................ 17
38 12 Construction of the NON-REUSABLE PACK .......................................................................................................... 18
39 13 MARKINGS on the ACTIVE IMPLANTABLE MEDICAL DEVICE .................................................................................. 18
40 14 Protection from unintended biological effects being caused by the ACTIVE IMPLANTABLE MEDICAL
41 DEVICE ............................................................................................................................................................................... 19
42 15 Protection from HARM to the patient or user caused by external physical features of the ACTIVE
43 IMPLANTABLE MEDICAL DEVICE ...................................................................................................................................... 19
COPYRIGHT PROTECTED DOCUMENT 44 16 Protection from HARM to the patient caused by electricity .................................................................... 19
© ISO 201845 17 Protection from HARM to the patient caused by heat ............................................................................... 25
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 18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE MEDICAL
below or ISO’s member body in the country of the requester.47 DEVICE ............................................................................................................................................................................... 26
ISO copyright officeCP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva 48 19 Protection from unintended effects caused by the device..................................................................... 26
Phone: +41 22 749 01 11Fax: +41 22 749 09 47
49 20 Protection of the device from damage caused by external defibrillators ........................................ 28
Email: copyright@iso.orgWebsite: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved © ISO 2018 – All rights reserved 3
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oSIST prEN ISO 14708-6:2018
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ISO 14708-6:201x
24 Contents
25 Foreword .......................................................................................................................................................................... 5
26 Introduction..................................................................................................................................................................... 6
27 1 Scope ............................................................................................................................................................................... 7
28 2 Normative references ............................................................................................................................................... 7
29 3 Terms and definitions .............................................................................................................................................. 8
30 4 Symbols and abbreviated terms ........................................................................................................................ 12
31 5 General requirements for non-implantable parts ...................................................................................... 12
32 6 Measurement of IMPLANTABLE PULSE GENERATOR and LEAD characteristics ............................................ 12
33 7 General arrangement of the packaging ........................................................................................................... 15
34 8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES ......................................................................... 15
35 9 MARKINGS on the SALES PACKAGING ........................................................................................................................ 16
36 10 Construction of the SALES PACKAGING ............................................................................................................... 17
37 11 MARKINGS on the STERILE PACK ............................................................................................................................ 17
38 12 Construction of the NON-REUSABLE PACK .......................................................................................................... 18
39 13 MARKINGS on the ACTIVE IMPLANTABLE MEDICAL DEVICE .................................................................................. 18
40 14 Protection from unintended biological effects being caused by the ACTIVE IMPLANTABLE MEDICAL
41 DEVICE ............................................................................................................................................................................... 19
42 15 Protection from HARM to the patient or user caused by external physical features of the ACTIVE
43 IMPLANTABLE MEDICAL DEVICE ...................................................................................................................................... 19
44 16 Protection from HARM to the patient caused by electricity .................................................................... 19
45 17 Protection from HARM to the patient caused by heat ............................................................................... 25
46 18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE MEDICAL
47 DEVICE ............................................................................................................................................................................... 26
48 19 Protection from unintended effects caused by the device..................................................................... 26
49 20 Protection of the device from damage caused by external defibrillators ........................................ 28
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50 21 Protection of the device from changes caused by high-power electrical fields applied directly
51 to the patient ................................................................................................................................................................ 28
52 22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by miscellaneous
53 medical instruments .................................................................................................................................................. 28
54 23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces ................................ 28
55 24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic
56 discharge ........................................................................................................................................................................ 34
57 25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmospheric
58 pressure changes ........................................................................................................................................................ 34
59 26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by temperature
60 changes ........................................................................................................................................................................... 34
61 27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from electromagnetic non-ionizing
62 radiation ........................................................................................................................................................................ 34
63 28 Accompanying documentation ........................................................................................................................ 34
64 Annex A (informative) Relationship between the fundamental principles in ISO/TR 14283 and
65 the clauses of this standard..................................................................................................................................... 40
66 Annex B (informative) Relationship between the clauses of this standard and the fundamental
67 principles listed in Annex A .................................................................................................................................... 61
68 Annex C (informative) Notes on ISO 14708-6 .................................................................................................. 63
69 Annex D (informative) Code for describing modes of IMPLANTABLE PULSE GENERATORS ...................... 76
70 Annex E (informative) Defined terms ................................................................................................................ 79
71 Bibliography ................................................................................................................................................................. 81
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73 Foreword
74 ISO (the International Organization for Standardization) is a worldwide federation of national
75 standards bodies (ISO member bodies). The work of preparing International Standards is normally
76 carried out through ISO technical committees. Each member body interested in a subject for which a
77 technical committee has been established has the right to be represented on that committee.
78 International organizations, governmental and non-governmental, in liaison with ISO, also take part in
79 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
80 matters of electrotechnical standardization.81 The procedures used to develop this document and those intended for its further maintenance are
82 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
83 different types of ISO documents should be noted. This document was drafted in accordance with the
84 editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives85 Attention is drawn to the possibility that some of the elements of this document may be the subject of
86 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
87 any patent rights identified during the development of the document will be in the Introduction and/or
88 on the ISO list of patent declarations received. www.iso.org/patents89 Any trade name used in this document is information given for the convenience of users and does not
90 constitute an endorsement.91 ISO 14708-6 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
92 SC 6, Active implants.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 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the
101 functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia, to provide basic
102 assurance of safety for both patients and users.103 An external defibrillator is a MEDICAL DEVICE used, in the emergency setting, to deliver a high-energy
104 shock to the heart, by means of ELECTRODEs applied to the external chest wall, in patients suffering
105 ventricular fibrillation (a rapid, disorganized and potentially lethal heart rhythm abnormality), to
106 restore normal heart action. External defibrillators can also be used, in emergency or elective settings,
107 to terminate other ventricular or atrial tachyarrhythmias by delivery of a high-energy shock,
108 synchronized to the intrinsic cardiac rhythm, a procedure known as CARDIOVERSION. In patients known
109 to be at RISK of such arrhythmias, due to the occurrence of previous episodes or the presence of specific
110 predisposing cardiac conditions, an IMPLANTABLE CARDIOVERTER DEFIBRILLATOR might be implanted to
111 perform similar functions. The implantable device, which is much smaller than an external defibrillator,
112 is contained within a sealed, encapsulating enclosure. It generates high voltage PULSES from an enclosed,
113 miniature, electrical battery. The PULSES are transmitted to the heart by means of implanted, insulated
114 conductors with ELECTRODEs (LEADS). The IMPLANTABLE CARDIOVERTER DEFIBRILLATOR can also incorporate
115 other sensing and pacing functions, such as rate support for bradycardia and ANTITACHYCARDIA PACING
116 (ATP) to terminate certain tachyarrhythmias without the need of a high-energy shock. The defibrillator
117 can be adjusted non-invasively by means of an electronic device, known as a programmer.
118 In recent years, other active implantable cardiovascular devices have emerged, most notably devices
119 that perform the function of improving cardiac output by optimizing ventricular synchrony, in addition
120 to performing ICD functions.121 Although these devices can deliver an additional therapy with respect to ICD devices, most of their
122 requirements are similar so that, in most cases, the concepts that apply to ICDs also apply to CRT-D
123 devices, and the appropriate way to test a CRT-D device is similar to the way ICDs are tested.
124 This document is relevant to all parts of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat
125 tachyarrhythmia other than pacing functions to control bradyarrhythmia or provide cardiac
126 resynchronization. Typical examples are IMPLANTABLE PULSE GENERATORs, LEADS, ADAPTORS, ACCESSORIES,
127 programmers and the related software (bradyarrhythmia and cardiac resynchronization pacing
128 functions are dealt with in ISO 14708-2).129 The requirements of this document supplement or modify those of ISO 14708-1, Implants for surgery —
130 Active implantable medical devices — Part 1: General requirements for safety, marking and for
131 information to be provided by the manufacturer, hereinafter referred to as ISO 14708-1. The
132 requirements of this document take priority over those of ISO 14708-1.133 Figures or tables that are additional to those of ISO 14708-1 are numbered starting from 101.
134 Annex D describes a coding system that may be used to designate tachyarrhythmia therapy modes. All
135 annexes are informative.6 © ISO 2018 – All rights reserved
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136 Implants for surgery — Active implantable medical devices —
137 Part 6: Particular requirements for active implantable medical
138 devices intended to treat tachyarrhythmia (including implantable
139 defibrillators)
140 1 Scope
141 This document specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
142 AND CRT-DS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia.
143 The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to
144 show compliance.145 This document was designed for tachyarrhythmia PULSE generators used with either endocardial or
146 epicardial LEADs. At the time of this edition, the authors recognized the emergence of technologies that
147 do not use ENDOCARDIAL or EPICARDIAL LEADS for which adaptations of this part will be required. Such
148 adaptations are left to the discretion of MANUFACTURERS incorporating these technologies.
149 This document is also applicable to some non-implantable parts and accessories of the devices (see
150 Note 1).151 The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either the
152 appropriate method detailed in this document or by any other method demonstrated to have accuracy
153 equal to, or better than, the method specified. In the case of dispute, the method detailed in this
154 document shall apply.155 Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias or cardiac
156 resynchronization is covered by ISO 14708-2.157 NOTE 1 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE might in fact be a single
158 device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of
159 these parts are required to be either partially or totally implantable, but there is a need to specify some
160 requirements of non-implantable parts and accessories if they could affect the safety or performance of the
161 implantable device.162 NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of
163 Directive 90/385/EEC.164 NOTE 3 In this document, terms printed in small capital letters are used as defined in Clause 3. Where a defined
165 term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified
166 is also defined.167 NOTE 4 Particular requirements for congestive heart failure devices are under consideration. These types of
168 devices are not covered by this document.169 2 Normative references
170 The following documents, in whole or in part, are normatively referenced in this document and are
171 indispensable for its application. For dated references, only the edition cited applies. For undated
172 references, the latest edition of the referenced document (including any amendments) applies.
173 ISO 5841-3:2013, Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for
174 implantable pacemakers© ISO 2018 – All rights reserved 7
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175 ISO 8601:2004, Data elements and interchange formats — Information interchange — Representation of
176 dates and times177 ISO 11318:2002, Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators —
178 Dimensions and test requirements179 ISO 14117:2018, Active implantable medical devices — Electromagnetic compatibility — EMC test
180 protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
181 ISO 14708-1:2014, Implants for surgery — Active implantable medical devices — Part 1: General
182 requirements for safety, marking and for information to be provided by the manufacturer
183 ISO 14708-2:2018, Implants for surgery — Active implantable medical devices — Part 2: Cardiac
184 pacemakers185 ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information
186 to be supplied — Part 1: General requirements187 IEC 60878, Graphical symbols for electrical equipment in medical practice
188 3 Terms and definitions
189 For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following
190 apply.191 ISO Online browsing platform: available at http://www.iso.org/obp
192 IEC Electropedia: available at http://www.electropedia.org/
193 3.101
194 adaptor
195 special connector used between an otherwise incompatible IMPLANTABLE PULSE GENERATOR and a LEAD
196 [SOURCE: ISO 14708-2:2018, 3.102]197 3.102
198 implantable cardioverter defibrillator
199 ICD
200 ACTIVE IMPLANTABLE MEDICAL DEVICE comprising an IMPLANTABLE PULSE GENERATOR and LEAD(S) that is
201 intended to detect and correct tachycardias and fibrillation by application of
202 CARDIOVERSION/DEFIBRILLATION PULSE(s) to the heart203 3.103
204 implantable pulse generator
205 IPG
206 part of the ACTIVE IMPLANTABLE MEDICAL DEVICE, including the power supply and electronic circuit that
207 produces an electrical output208 NOTE 1 to entry: For purposes of this document, the term IMPLANTABLE PULSE GENERATOR describes any ACTIVE
209 IMPLANTABLE MEDICAL DEVICE that incorporates functions intended to treat tachyarrhythmias.
210 [SOURCE: ISO 14708-2:2018, 3.104, modified – “ACTIVE IMPLANTABLE MEDICAL DEVICE” substituted for
211 “PACEMAKER”, NOTE 1 to entry added]8 © ISO 2018 – All rights reserved
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212 3.104
213 sensitivity
214 sensing threshold
215 minimum signal required to consistently control the function of the IMPLANTABLE PULSE GENERATOR
216 [SOURCE: ISO 14708-2:2018, 3.108]217 3.106
218 electrode
219 electrically conducting part (usually the termination of a LEAD), which is designed to form an interface
220 with body tissue or body fluid221 [SOURCE: ISO 14708-2:2018, 3.109]
222 3.107
223 endocardial lead
224 LEAD with an ELECTRODE designed to make a contact with the endocardium, or inner surface of the heart
225 [SOURCE: ISO 14708-2:2018, 3.112]226 3.108
227 epicardial lead
228 LEAD with an ELECTRODE designed to make a contact with the epicardium, or outer surface of the heart
229 [SOURCE: ISO 14708-2:2018, 3.113]230 3.109
231 transvenous
232 approach to the heart through the venous system
233 [SOURCE: ISO 14708-2:2018, 3.114]
234 3.110
235 insertion diameter
236 lead
237 minimum bore of a rigid cylindrical tube into which the LEAD (not including the connector) can be
238 inserted239 [SOURCE: ISO 14708-2:2018, 3.115]
240 3.112
241 lead pacing impedance
242 Z
243 impedance that is formed by the ratio of a voltage PULSE to the resulting current
244 [SOURCE: ISO 14708-2:2018, 3.117].245 3.114
246 model designation
247 name and/or a combination of letters and numbers used by a MANUFACTURER to distinguish, by function
248 or type, one device from another249 [SOURCE: ISO 14708-2:2018, 3.119]
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250 3.115
251 serial number
252 unique combination of letters and/or numbers, selected by the MANUFACTURER, intended to distinguish a
253 device from other devices with the same MODEL DESIGNATION254 [SOURCE: ISO 14708-2:2018, 3.120]
255 3.117
256 pulse
257 electrical output of an IMPLANTABLE PULSE GENERATOR other than CD PULSE intended to stimulate the
258 myocardium259 [SOURCE: ISO 14708-2:2018, 3.122, modified – added “other than CD PULSE”.]
260 3.118
261 pulse amplitude
262 amplitude of the PULSE
263 [SOURCE: ISO 14708-2:2018, 3.123]
264 3.119
265 pulse duration
266 duration of the PULSE
267 [SOURCE: ISO 14708-2:2018, 3.124]
268 3.120
269 pulse interval
270 interval between equivalent points of two consecutive PULSEs
271 [SOURCE: ISO 14708-2:2018, 3.125]
272 3.122
273 automatic sensitivity control
274 automatic adjustment of the SENSITIVITY in response to available physiological signals
275 3.123276 beginning of service
277 BOS
278 time at which an individual IMPLANTABLE PULSE GENERATOR is first released by the MANUFACTURER as fit for
279 being placed on the market280 [SOURCE: ISO 14708-2:2018, 3.138]
281 3.124
282 end of service
283 EOS
284 time at which the PROLONGED SERVICE PERIOD has elapsed and no further pacing function is specified nor
285 can be expected286 [SOURCE: ISO 14708-2: 2018, 3.139]
10 © ISO 2018 – All rights reserved
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287 3.125
288 prolonged service period
289 PSP
290 period beyond the RECOMMENDED REPLACEMENT TIME during which the IMPLANTABLE PULSE GENERATOR
291 continues to function as specified by the MANU...
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