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ČSN EN ISO 14708-6 (853010)
Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
Translate name
STANDARD published on 1.1.2023
The information about the standard:
Designation standards: ČSN EN ISO 14708-6
Classification mark: 853010
Catalog number: 515976
Publication date standards: 1.1.2023
SKU: NS-1097973
The number of pages: 80
Approximate weight : 240 g (0.53 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 14708-6 (853010):
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
Preview of the standard ČSN EN ISO 14708-6 (853010)
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