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BS EN ISO 14708-6:2022

BS EN ISO 14708-6:2022

$215.11

Implants for surgery. Active implantable medical devices – Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

Published By Publication Date Number of Pages
BSI 2022 76
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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.

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PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
14 4 Symbols and abbreviated terms
5 General requirements for non-implantable parts
5.1 General requirements for non-implantable parts
5.2 General requirements for software
5.3 Usability of non-implantable parts
5.4 Data security and protection from harm caused by unauthorized information tampering
5.5 General requirements for risk management
5.6 Misconnection of parts of the active implantable medical device
6 Measurement of implantable pulse generator and lead characteristics
6.1 Measurement of implantable pulse generator characteristics
6.1.1 General considerations
15 6.1.2 Measurement of the bradyarrhythmia characteristics
6.1.3 Measurement of ICD output voltage
16 6.1.4 Measurement of delivered CD pulse energy
6.1.5 Measurement of the antitachyarrhythmia pacing pulse amplitude
6.1.6 Measurement of the sensitivity of an implantable pulse generator with automatic sensitivity control
17 6.1.7 Charge time
6.1.8 Capacitor formation (capacitor maintenance)
6.2 Measurement of the electrical characteristic of a sensing/pacing lead
7 General arrangement of the packaging
8 General markings for active implantable medical devices
9 Markings on the sales packaging
19 10 Construction of the sales packaging
11 Markings on the sterile pack
21 12 Construction of the non-reusable pack
13 Markings on the active implantable medical device
14 Protection from unintended biological effects being caused by the active implantable medical device
22 15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device
16 Protection from harm to the patient caused by electricity
26 17 Protection from harm to the patient caused by heat
17.1 Protection from harm to the patient caused by heat
27 17.2 Active implantable medical device intended to supply heat
18 Protection from ionizing radiation released or emitted from the active implantable medical device
19 Protection from unintended effects caused by the device
28 20 Protection of the device from damage caused by external defibrillators
29 21 Protection of the device from changes caused by high-power electrical fields applied directly to the patient
22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments
23 Protection of the active implantable medical device from mechanical forces
33 24 Protection of the active implantable medical device from damage caused by electrostatic discharge
34 25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes
26 Protection of the active implantable medical device from damage caused by temperature changes
27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation
28 Accompanying documentation
40 Annex A (informative) Relationship between the fundamental principles in ISO/TR 14283 and the clauses of this document
61 Annex B (informative) Notes on ISO 14708-6
72 Annex C (informative) Code for describing modes of implantable pulse generators
74 Bibliography

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BS EN ISO 14708-6:2022
$215.11