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BS EN ISO 14708-7:2022

BS EN ISO 14708-7:2022

$215.11

Implants for surgery. Active implantable medical devices – Particular requirements for cochlear and auditory brainstem implant systems

Published By Publication Date Number of Pages
BSI 2022 80
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
11 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
12 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
13 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
14 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
15 17 Protection from harm to the patient caused by heat
16 18 Protection from ionizing radiation released or emitted from the active implantable medical device
19 Protection from unintended effects caused by the device
17 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
18 22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments
26 23 Protection of the active implantable medical device from mechanical forces
30 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
31 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
33 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
34 27.4.2 Operating functions, modes and settings
27.4.3 Patient physiological simulation
27.5 Acceptance Criteria
35 28 Accompanying documentation
39 Annex A (informative) General guidance and rationale
50 Annex B (informative) Relationship between the fundamental principles in ISO/TR 14283 and the clauses of this document
71 Annex C (informative) Notes on EN 45502‑2‑3 (basis for this document)
72 Annex D (informative) Notes on EMI measurements to demonstrate compliance with Clause 27
76 Bibliography

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BS EN ISO 14708-7:2022
$215.11