This document specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this document. 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 is also applicable to non-implantable parts and accessories of the devices (see NOTE). The electrical characteristics of the implantable part are determined by either the appropriate method detailed in this document or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document applies. NOTE A 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, this document specifies those requirements of non-implantable parts and accessories which could affect the safety or performance of the implantable part.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | National foreword <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword <\/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 | ||||||
| 11<\/td>\n | 4 Symbols and abbreviations 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 5.7 Protection against external electrical hazards for fully implantable systems <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 6 Inspection and measurement 6.1 General 6.2 Measurement of output signal characteristics 6.3 Measurement of the output signal amplitude and pulse width 6.4 Impedance measurement accuracy 6.5 Inductive link characterization 6.6 Sound processor battery testing 7 General arrangement of the packaging 8 General markings for active implantable medical devices 9 Markings on the sales packaging <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 10 Construction of the sales packaging 11 Markings on the sterile pack 12 Construction of the non-reusable pack 13 Markings on the active implantable medical device <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 14 Protection from unintentional biological effects being caused by the active implantable medical device 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 | ||||||
| 15<\/td>\n | 17 Protection from harm to the patient caused by heat <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 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 | ||||||
| 17<\/td>\n | 20 Protection of the device from damage caused by external defibrillators 21 Protection of the device from changes caused by high power electrical fields applied directly to the patient <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 23 Protection of the active implantable medical device from mechanical forces <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 24 Protection of the active implantable medical device from damage caused by electrostatic discharge 25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 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-ionising radiation 27.1 Protection from static magnetic fields 27.2 Radiated magnetic field test for frequencies 16,6 Hz to 27 MHz <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 27.3 Radiated electric field test for frequencies 10 MHz to 2,7 GHz 27.4 General test configuration and setup 27.4.1 Test configuration and setup <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 27.4.2 Operating functions, modes and settings 27.4.3 Patient physiological simulation 27.5 Acceptance Criteria <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 28 Accompanying documentation <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | Annex A (informative) General guidance and rationale <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | Annex B (informative) Relationship between the fundamental principles in ISO\/TR 14283 and the clauses of this document <\/td>\n<\/tr>\n | ||||||
| 71<\/td>\n | Annex C (informative) Notes on EN 45502\u20112\u20113 (basis for this document) <\/td>\n<\/tr>\n | ||||||
| 72<\/td>\n | Annex D (informative) Notes on EMI measurements to demonstrate compliance with Clause 27 <\/td>\n<\/tr>\n | ||||||
| 76<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Implants for surgery. Active implantable medical devices – Particular requirements for cochlear and auditory brainstem implant systems<\/b><\/p>\n |