1、 ISO 2013 Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems Implants chirurgicaux Dispositifs mdicaux implantables actifs Partie 7: Exigences particulires pour les systmes dimplant cochlaire INTERNATIONAL STANDARD ISO 14708-7 First e
2、dition 2013-01-15 Reference number ISO 14708-7:2013(E) ISO 14708-7:2013(E)ii ISO 2013 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2013 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechan
3、ical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.
4、org Published in Switzerland ISO 14708-7:2013(E) ISO 2013 All rights reserved iii Contents Page Foreword v Introduction vi 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 2 4 Symbols and abbreviations . 3 5 General requirements for non-implantable parts 3 6 Inspection and measurement
5、 . 4 6.1 Measurement of output signal characteristics 4 6.2 Measurement of the output signal amplitude and pulse width 4 6.3 Impedance measurement accuracy 4 7 General arrangement of the packaging 5 8 General markings for active implantable medical devices 5 9 Markings on the s ales p a cka ging . 5
6、 10 Construction of the s ales p a cka ging . 6 11 Markings on the sterile pack 6 12 Construction of the non-reusable pack . 6 13 Markings on the active implantable medical device . 7 14 Protection from unintentional biological effects being caused by the active implantable medical device. 7 15 Prot
7、ection from harm to the patient or user caused by external physical features of the active implantable medical device . 8 16 Protection from harm to the patient caused by electricity 8 17 Protection from harm to the patient caused by heat 8 18 Protection from ionizing radiation released or emitted f
8、rom the active implantable medical device. 8 19 Protection from unintended effects caused by the device 9 20 Pr ot ection of the de vic e fr om damage caused by e xt ernal defibrillat ors .9 21 Pr ot ection of the de vic e fr om changes caused by hig h po w er electrical fields applied directly to t
9、he patient .10 22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments 10 23 Protection of the active implantable medical device from mechanical forces .13 24 Protection of the active implantable medical device from damage caused by electrostati
10、c discharge 18 25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes 18 26 Protection of the active implantable medical device from damage caused by temperature changes 18 27 Protection of the active implantable medical device from electromagnetic
11、non- ionising radiation .19 28 Accompanying documentation .21 ISO 14708-7:2013(E)iv ISO 2013 All rights reserved Annex AA (informative) Relationship between the fundamental principles in ISO/TR 14283 and the clauses of this part of ISO 14708 24 Annex BB (informative) Relationship between the clauses
12、 of this part of ISO 14708 and the fundamental principles listed in Annex A .37 Annex CC (informative) Notes on EN 45502-2-3 (basis for this part of ISO 14708) .39 Annex DD (informative) Notes on theoretical modelling to demonstrate compliance with Clause 27 47 Annex EE (informative) Notes on EMI me
13、asurements to demonstrate compliance with Clause 27 49 Bibliography .53 ISO 14708-7:2013(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried
14、out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
15、collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare Internationa
16、l Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the eleme
17、nts of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14708-7 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6, Active implants. ISO 14708 consists of the following parts,
18、under the general title Implants for surgery Active implantable medical devices: Part 1: General requirements for safety, marking and for information to be provided by the manufacturer Part 2: Cardiac pacemakers Part 3: Implantable neurostimulators Part 4: Implantable infusion pumps Part 5: Circulat
19、ory support devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) Part 7: Particular requirements for cochlear implant systems ISO 2013 All rights reserved v ISO 14708-7:2013(E) Introduction This Intern
20、ational Standard specifies particular requirements for ac t i v e impl a n ta ble medic a l de v ices used to treat hearing impairment via electrical stimulation (for example cochlear implant systems or auditory brainstem implant systems), to provide basic assurance of safety for both patients and u
21、sers. A cochlear implant system or auditory brainstem implant system is an active implantable medical device comprising implantable and non-implantable parts (external parts). The power source may be externally derived or from an internal battery. The implant system is designed to restore hearing vi
22、a electrical stimulation of the auditory pathways. Externally or internally processed acoustic information is converted to electrical stimulation signals which are delivered via one or more electrodes. The working parameters of the device may be adjusted via a non-implantable accessory. This Interna
23、tional Standard is relevant to all parts of implant systems, including accessories. The requirements of this International Standard supplement or modify those of ISO 14708-1, Implants for surgery Active implantable medical devices Part 1: General requirements for safety, marking and for information
24、to be provided by the manufacturer. Figures or tables that are additional to those of Part 1 are numbered starting from 101; additional annexes are lettered AA, BB, etc. In this part of ISO 14708, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as
25、 a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.vi ISO 2013 All rights reserved Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems 1 Scope This part of ISO 147
26、08 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 part
27、 of ISO 14708. The tests that are specified in this part of ISO 14708 are type tests and are to be carried out on samples of a device to show compliance. This part of ISO 14708 is also applicable to non-implantable parts and accessories of the devices (see NOTE). The electrical characteristics of th
28、e implantable part are determined by either the appropriate method detailed in this part of ISO 14708 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 part of ISO 14708 applies. NOTE A device t
29、hat 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
30、 specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable part. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For
31、dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. This clause of ISO 14708-1 applies except as follows: Additional references: ISO 10993-1, Biological evaluation of medical devices Part 1: Evalu
32、ation and testing within a risk management process ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice ISO 149
33、71, Medical devices Application of risk management to medical devices IEC 60068-2-27, Environmental testing Part 2-27: Tests Test Ea and guidance: Shock IEC 60068-2-31, Environmental testing Part 2-31: Tests Test Ec: Rough handling shocks, primarily for equipment-type specimens IEC 60068-2- 47, Envi
34、ronmental testing Part 2-47: Test Mounting of specimens for vibration, impact and similar dynamic tests INTERNATIONAL ST ANDARD ISO 14708-7:2013(E) ISO 2013 All rights reserved 1 ISO 14708-7:2013(E) IEC 60068-2-64, Environmental testing Part 2-64: Tests Test Fh: Vibration, broadband random and guida
35、nce IEC 60068-2-75, Environmental testing Part 2-75: Tests Test Eh: Hammer tests IEC 60118-6, Hearing aids Part 6: Characteristics of electrical input circuits for hearing aids IEC 60601-1:2006, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC
36、60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests IEC 61000-4-2, Electromagnetic compatibility (EMC) Part 4-2: Testing and measurement techniques Electrostatic di
37、scharge immunity test IEC 62304, Medical device software Software life cycle processes EN 1593, Non-destructive testing Leak testing Bubble emission techniques EN 13185, Non-destructive testing Leak testing Tracer gas method 3 T erms an d definiti ons For the purposes of this document, the terms and
38、 definitions given in ISO 14708-1 and the following apply. 3.3.1 cochlear implant system CIS active implantable medical device, comprising implantable and non-implantable parts , intended to treat hearing impairment via electrical stimulation of the cochlea 3.3.2 auditory brainstem implant system BI
39、S active implantable medical device, comprising implantable and non-implantable parts, intended to treat hearing impairment via electrical stimulation of the auditory brainstem 3.3.3 implant system either cochlear implant system or auditory brainstem implant system 3.3.4 non-implantable part externa
40、l part of the implant system Note 1 to entry: Examples would include, but are not limited to, sound processor, microphone, coil or power source. 3.3.5 stimulator implantable part of the implant system containing electronic circuitry required to produce electrical stimulation 3.3.6 body-worn non-impl
41、antable part of the implant system and worn on the body (e.g. belt or ear level) 3.5.1 electrode contact electrically conducting part which is designed to form an interface with body tissue or body fluid2 ISO 2013 All rights reserved ISO 14708-7:2013(E) 3.5.2 electrode array distal part of a lead co
42、ntaining more than one electrode contact 3.5.3 reference electrode electrically conducting part designed as return path for electrical stimulation current 3.5.4 distal located away from the point of attachment to the stimulator 3.5.5 proximal located closest to the point of attachment to the stimula
43、tor 3.9.1 model designation name and/or a combination of letters and numbers used by a manufacturer to distinguish, by function or type, one device from another 3.9.2 serial number unique combination of letters and/or numbers, selected by the manufacturer, intended to distinguish a device from other
44、 devices with the same model designation 3.20.1 output signal electrical output, either pulsatile or analogue, of an implant system intended to stimulate the auditory pathways 3.20.2 pulse specified electrical output signal (voltage or current) of a specified amplitude and duration 3.20.3 biphasic p
45、ulse pulse which has both negative and positive going phases 3.22.1 use-before-date date after which the manufacturer recommends that the implant system should not be implanted 3.22.2 magnet component producing an external magnetic flux 4 Symbols and abbreviations There are no requirements specified
46、 in this part of ISO 14708. However this does not preclude the use of symbols defined in other standards nor special symbols defined in the accompanying documentation. 5 General requirements for non-implantable parts 5.1 This subclause of ISO 14708-1 applies. ISO 2013 All rights reserved 3 ISO 14708
47、7:2013(E) 5.2 Replacement Software of an active implantable medical device or software that falls within the definition of an active implantable medical device shall be designed according to software life cycle process activities compliant with IEC 62304 and validated. 6 Inspection and measurement
48、If this part of ISO 14708 refers to inspection of design analysis documentation provided by the manufacturer, it shall include an inspection of the risk management file as required by ISO 14971. 6.1 Measurement of output signal characteristics The measurement shall be performed with the implantable
49、part of the implant system at a temperature of (37 2) C. The implant system shall be configured to use its maximum number of outputs and each output shall be programmed to its maximum value (amplitude and pulse width). An input signal equivalent to 70dB SPL shall be applied to the microphone. Where applicable, the transcutaneous link shall operate over a distance of (5 1) mm. Where the implant system provides alternative output signals each shall be measured and lis
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