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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 6.1.2 Measurement of the bradyarrhythmia characteristics 6.1.3 Measurement of ICD output voltage <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 10 Construction of the sales packaging 11 Markings on the sterile pack <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 17 Protection from harm to the patient caused by heat 17.1 Protection from harm to the patient caused by heat <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 20 Protection of the device from damage caused by external defibrillators <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 24 Protection of the active implantable medical device from damage caused by electrostatic discharge <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Annex A (informative) Relationship between the fundamental principles in ISO\/TR 14283 and the clauses of this document <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | Annex B (informative) Notes on ISO 14708-6 <\/td>\n<\/tr>\n | ||||||
| 72<\/td>\n | Annex C (informative) Code for describing modes of implantable pulse generators <\/td>\n<\/tr>\n | ||||||
| 74<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Implants for surgery. Active implantable medical devices – Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)<\/b><\/p>\n |