kSIST FprEN ISO 14708-7:2019

SLOVENSKI STANDARD
oSIST prEN ISO 14708-7:2018
01-junij-2018

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Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 7: Exigences

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

28 Foreword .................................................................................................................................................................. 5

29 Introduction............................................................................................................................................................. 6

30 1 Scope....................................................................................................................................................................... 7

31 2 Normative references ........................................................................................................................................ 7

32 3 Terms and definitions ....................................................................................................................................... 8

33 4 Symbols and abbreviations........................................................................................................................... 10

34 5 General requirements for non-implantable parts.................................................................................. 10

35 6 Inspection and measurement....................................................................................................................... 10

36 7 General arrangement of the packaging ..................................................................................................... 11

37 8 General markings for active implantable medical devices .................................................................. 11

38 9 Markings on the SALES PACKAGING.................................................................................................................. 11

39 10 Construction of the SALES PACKAGING.......................................................................................................... 12

40 11 Markings on the sterile pack...................................................................................................................... 12

41 12 Construction of the non-reusable pack ................................................................................................... 13

42 13 Markings on the active implantable medical device ........................................................................... 13

43 14 Protection from unintentional biological effects being caused by the active implantable

44 medical device...................................................................................................................................................... 13

45 15 Protection from harm to the patient or user caused by external physical features of the active

46 implantable medical device ............................................................................................................................. 14

COPYRIGHT PROTECTED DOCUMENT 47 16 Protection from harm to the patient caused by electricity................................................................ 14

48 17 Protection from harm to the patient caused by heat........................................................................... 14

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address 49 18 Protection from ionizing radiation released or emitted from the active implantable medical

50 device...................................................................................................................................................................... 15

51 19 Protection from unintended effects caused by the device................................................................. 16

52 20 Protection of the device from damage caused by external defibrillators ..................................... 16

28 Foreword .................................................................................................................................................................. 5

29 Introduction ............................................................................................................................................................. 6

30 1 Scope ....................................................................................................................................................................... 7

31 2 Normative references ........................................................................................................................................ 7

32 3 Terms and definitions ....................................................................................................................................... 8

33 4 Symbols and abbreviations ........................................................................................................................... 10

34 5 General requirements for non-implantable parts .................................................................................. 10

35 6 Inspection and measurement ....................................................................................................................... 10

36 7 General arrangement of the packaging ..................................................................................................... 11

37 8 General markings for active implantable medical devices .................................................................. 11

38 9 Markings on the SALES PACKAGING .................................................................................................................. 11

39 10 Construction of the SALES PACKAGING .......................................................................................................... 12

40 11 Markings on the sterile pack ...................................................................................................................... 12

41 12 Construction of the non-reusable pack ................................................................................................... 13

42 13 Markings on the active implantable medical device ........................................................................... 13

43 14 Protection from unintentional biological effects being caused by the active implantable

44 medical device ...................................................................................................................................................... 13

45 15 Protection from harm to the patient or user caused by external physical features of the active

46 implantable medical device ............................................................................................................................. 14

47 16 Protection from harm to the patient caused by electricity ................................................................ 14

48 17 Protection from harm to the patient caused by heat ........................................................................... 14

49 18 Protection from ionizing radiation released or emitted from the active implantable medical

50 device ...................................................................................................................................................................... 15

51 19 Protection from unintended effects caused by the device ................................................................. 16

52 20 Protection of the device from damage caused by external defibrillators ..................................... 16

53 21 Protection of the device from changes caused by high power electrical fields applied directly

54 to the patient ........................................................................................................................................................ 17

55 22 Protection of the active implantable medical device from changes caused by miscellaneous

56 medical treatments ............................................................................................................................................. 17

57 23 Protection of the active implantable medical device from mechanical forces ............................. 26

58 24 Protection of the active implantable medical device from damage caused by electrostatic

59 discharge ............................................................................................................................................................... 30

60 25 Protection of the active implantable medical device from damage caused by atmospheric

61 pressure changes ................................................................................................................................................. 30

62 26 Protection of the active implantable medical device from damage caused by temperature

63 changes ................................................................................................................................................................... 30

64 27 Protection of the active implantable medical device from electromagnetic non-ionising

65 radiation ................................................................................................................................................................ 31

66 28 Accompanying documentation .................................................................................................................. 37

67 Annex AA (informative) General guidance and rationale ....................................................................... 41

68 Annex BB (informative) Relationship between the fundamental principles in ISO/TR 14283 and

69 the clauses of this part of ISO 14708 .............................................................................................................. 53

70 Annex CC (informative) Notes on EN 45502-2-3 (basis for this part of ISO 14708) ........................ 67

71 Annex DD (informative) Notes on EMI measurements to demonstrate compliance with Clause 27

72 .................................................................................................................................................................................. 68

73 Bibliography ......................................................................................................................................................... 72

76 ISO (the International Organization for Standardization) is a worldwide federation of national

77 standards bodies (ISO member bodies). The work of preparing International Standards is normally

78 carried out through ISO technical committees. Each member body interested in a subject for which a

79 technical committee has been established has the right to be represented on that committee.

80 International organizations, governmental and non-governmental, in liaison with ISO, also take part in

81 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all

83 The procedures used to develop this document and those intended for its further maintenance are

84 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

85 different types of ISO documents should be noted. This document was drafted in accordance with the

87 Attention is drawn to the possibility that some of the elements of this document may be the subject of

88 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

89 any patent rights identified during the development of the document will be in the Introduction and/or

91 Any trade name used in this document is information given for the convenience of users and does not

93 For an explanation on the meaning of ISO specific terms and expressions related to conformity

94 assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO)

97 This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee

99 This second edition cancels and replaces the first edition (ISO 14708-7:2013), which has been

104  many clauses have been replaced by references to the ANSI/AAMI CI86:2017 standard

107 This document specifies particular requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES used to treat

108 hearing impairment via electrical stimulation (for example cochlear implant systems or auditory

109 brainstem implant systems), to provide basic assurance of safety for both patients and users.

110 A COCHLEAR IMPLANT SYSTEM or AUDITORY BRAINSTEM IMPLANT SYSTEM is an ACTIVE IMPLANTABLE MEDICAL

111 DEVICE comprising implantable and NON-IMPLANTABLE PARTS (external parts). The power source may be

112 externally derived or from an internal battery. The IMPLANT SYSTEM is designed to restore hearing via

113 electrical stimulation of the auditory pathways. Externally or internally processed acoustic information

114 is converted to electrical stimulation signals which are delivered via one or more electrodes. The

115 working parameters of the device may be adjusted via a non-implantable accessory.

116 This document is relevant to all parts of IMPLANT SYSTEMS, including accessories.

117 The requirements of this document supplement or modify those of ISO 14708-1, Implants for surgery —

118 Active implantable medical devices — Part 1: General requirements for safety, marking and for

120 Figures or tables that are additional to those of Part 1 are numbered starting from 101; additional

122 In this part of ISO 14708, terms printed in small capital letters are used as defined in Clause 3. Where a

123 defined term is used as a qualifier in another term, it is not printed in small capital letters unless the

128 This part of ISO 14708 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL

129 DEVICES that are intended to treat hearing impairment via electrical stimulation of the auditory

130 pathways. Devices which treat hearing impairment via means other than electrical stimulation are not

132 The tests that are specified in this part of ISO 14708 are type tests and are to be carried out on samples

134 This part of ISO 14708 is also applicable to NON-IMPLANTABLE PARTS and accessories of the devices (see

136 The electrical characteristics of the IMPLANTABLE PART are determined by either the appropriate method

137 detailed in this part of ISO 14708 or by any other method demonstrated to have an accuracy equal to, or

138 better than, the method specified. In the case of dispute, the method detailed in this part of ISO 14708

140 NOTE A device that is commonly referred to as an active implantable medical device can in fact be a single

141 device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of

142 these parts are required to be either partially or totally implantable, this standard specifies those requirements of

143 NON-IMPLANTABLE PARTS and accessories which could affect the safety or performance of the implantable part.

145 The following documents are referred to in the text in such a way that some or all of their content

146 constitutes requirements of this document. For dated references, only the edition cited applies. For

147 undated references, the latest edition of the referenced document (including any amendments) applies.

150 ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

152 ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,

154 ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

155 ISO 14971, Medical devices — Application of risk management to medical devices

156 IEC 60068-2-27, Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock

157 IEC 60068-2-31, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks, primarily

159 IEC 60068-2-47, Environmental testing — Part 2-47: Test — Mounting of specimens for vibration, impact

161 IEC 60068-2-64, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random and

163 IEC 60068-2-75, Environmental testing — Part 2-75: Tests — Test Eh: Hammer tests

164 IEC 60118-6, Hearing aids — Part 6: Characteristics of electrical input circuits for hearing aids

165 IEC 60601-1:2012, Medical electrical equipment — Part 1: General requirements for basic safety and

167 IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and

168 essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests

169 IEC 61000-4-2, Electromagnetic compatibility (EMC) — Part 4-2: Testing and measurement techniques —

174 ANSI/AAMI CI86:2017, Cochlear implant systems: Requirements for safety, functional verification,

177 For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following

179 ISO and IEC maintain terminological databases for use in standardization at the following addresses:

185 active implantable medical device, comprising implantable and NON-IMPLANTABLE PARTS, intended to

190 ACTIVE IMPLANTABLE MEDICAL DEVICE, comprising implantable and NON-IMPLANTABLE PARTS, intended to

191 treat hearing impairment via electrical stimulation of the auditory brainstem

198 Note 1 to entry Examples would include, but are not limited to, sound processor, microphone, coil or power

202 implantable part of the IMPLANT SYSTEM containing electronic circuitry required to produce electrical

206 NON-IMPLANTABLE PART of the IMPLANT SYSTEM and worn on the body (e.g. belt or ear level)

209 electrically conducting part which is designed to form an interface with body tissue or body fluid

215 electrically conducting part designed as return path for electrical stimulation current

224 name and/or a combination of letters and numbers used by a manufacturer to distinguish, by function

228 unique combination of letters and/or numbers, selected by the manufacturer, intended to distinguish a

232 electrical output, either pulsatile or analogue, of an IMPLANT SYSTEM intended to stimulate the auditory

236 specified electrical OUTPUT SIGNAL (voltage or current) of a specified amplitude and duration

242 date after which the manufacturer recommends that the IMPLANT SYSTEM should not be implanted

253 There are no requirements specified in this part of ISO 14708. However this does not preclude the use

254 of symbols defined in other standards nor special symbols defined in the accompanying documentation.

263 5.7 Protection against external electrical hazards for fully implantable systems

266 If this part of ISO 14708 refers to inspection of design analysis documentation provided by the

267 manufacturer, it shall include an inspection of the risk management file as required by ISO 14971.

288 The sales packaging shall bear the name and full address of the manufacturer.

289 The SALES PACKAGING shall also bear the name and address of the authorized representative, if the

290 manufacturer does not have a registered place of business in the European Community.

293 Where an IMPLANT SYSTEM is supplied in separate sub-assembly packaging, each individual SALES

294 PACKAGING shall bear a description of the contents of the packaging, the model designation or part

301 The SALES PACKAGING of implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall bear the USE-

316 NOTE Removable stickers, which provide supplementary information exceeding the information specified in