FprEN ISO 14708-7

Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO/FDIS 14708-7:2019)

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.

Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 7: Besondere Anforderungen an Cochlea-Implantat Systeme (ISO/FDIS 14708-7:2019)

Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 7: Exigences particulières pour les systèmes d'implant cochléaire (ISO/FDIS 14708-7:2019)

Le présent document spécifie les exigences applicables aux dispositifs médicaux implantables actifs qui sont destinés au traitement des altérations auditives par la stimulation électrique des voies auditives. Les dispositifs qui traitent les altérations auditives par des moyens autres que la stimulation électrique ne sont pas couverts par le présent document.
Les essais qui sont spécifiés dans le présent document sont des essais de type et doivent être réalisés sur des échantillons d'un dispositif afin d'en démontrer la conformité.
Le présent document est également applicable aux parties non implantables et aux accessoires des dispositifs (voir NOTE).
Les caractéristiques électriques de la partie implantable sont déterminées soit par la méthode appropriée détaillée dans le présent document, soit par toute autre méthode connue pour avoir une exactitude égale ou supérieure à la méthode spécifiée. En cas de litige, la méthode détaillée dans le présent document s'applique.
NOTE       Un dispositif couramment désigné comme dispositif médical implantable actif peut en fait être un dispositif individuel, une combinaison de dispositifs ou une combinaison d'un ou de plusieurs dispositifs avec un ou plusieurs accessoires. Ces parties ne sont pas nécessairement toutes implantables, en partie ou en totalité; le présent document spécifie les exigences applicables aux accessoires et parties non implantables qui peuvent affecter la sécurité ou les performances de la partie implantable.

Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 7. del: Posebne zahteve za sisteme s polžkovim vsadkom (ISO/FDIS 14708-7:2019)

General Information

• Status: Not Published
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/CLC/JTC 16 - CEN/CENELEC Joint Working Group on Active Implantable Medical Devices
• Current Stage: 6055 - CEN Ratification completed (DOR) - Publishing
• Due Date: 23-Aug-2019
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: kSIST FprEN ISO 14708-7:2019 - Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO/FDIS 14708-7:2019)

Standards Content (sample)

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

9VDGNLLPSODQWDWL]DNLUXUJLMR$NWLYQLPHGLFLQVNLSULSRPRþNL]DYVDGLWHYGHO

3RVHEQH]DKWHYH]DVLVWHPHVSROåNRYLPYVDGNRP,62',6
Implants for surgery - Active implantable medical devices - Part 7: Particular
requirements for cochlear implant systems (ISO/DIS 14708-7:2018)

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

particulières pour les systèmes d'implant cochléaire (ISO/DIS 14708-7:2018)
Ta slovenski standard je istoveten z: prEN ISO 14708-7
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14708-7:2018 en,fr,de

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

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oSIST prEN ISO 14708-7:2018
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oSIST prEN ISO 14708-7:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14708-7
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-03-27 2018-06-19
Implants for surgery — Active implantable medical
devices —
Part 7:
Particular requirements for cochlear implant systems
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 7: Exigences particulières pour les systèmes d'implant cochléaire
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14708-7:2018(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2018
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oSIST prEN ISO 14708-7:2018
ISO/DIS 14708-7:2018(E)
ISO 14708-7:201x
27 Contents

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

© ISO 2018

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

below or ISO’s member body in the country of the requester.

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

ISO copyright office
CP 401 • Ch. de Blandonnet 8

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

CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]

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

[e-mail]
www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved © ISO 2017 – All rights reserved 3
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oSIST prEN ISO 14708-7:2018
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27 Contents

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

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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

4 © ISO 2018 – All rights reserved
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oSIST prEN ISO 14708-7:2018
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75 Foreword

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

82 matters of electrotechnical standardization.

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

86 editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives

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

90 on the ISO list of patent declarations received. www.iso.org/patents

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

92 constitute an endorsement.

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)

95 principles in the Technical Barriers to Trade (TBT) see the following URL:
96 www.iso.org/iso/foreword.html.

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

98 SC 6, Active implants.

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

100 technically revised.
101 The main changes compared to the previous edition are:
102  alignment to the updated ISO 14708-1:2014
103  significant changes to clauses 17, 22, 27

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

105 A list of all part in the ISO 14708 series can be found on the ISO website.
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106 Introduction

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

119 information to be provided by the manufacturer.

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

121 annexes are lettered AA, BB, etc.

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

124 concept thus qualified is also defined.
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125 Implants for surgery — Active implantable medical devices —
126 Part 7: Particular requirements for cochlear implant systems
127 1 Scope

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

131 covered by this part of ISO 14708.

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

133 of a device to show compliance.

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

135 NOTE).

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

139 applies.

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.

144 2 Normative references

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.

148 This clause of ISO 14708-1 applies except as follows:
149 Additional references:

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

151 management process

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

153 sterile barrier systems and packaging systems

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

158 for equipment-type specimens

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

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

162 guidance

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

166 essential performance

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 —

170 Electrostatic discharge immunity test
171 IEC 62304, Medical device software — Software life cycle processes
172 EN 1593, Non-destructive testing — Leak testing — Bubble emission techniques
173 EN 13185, Non-destructive testing — Leak testing — Tracer gas method

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

175 labeling and reliability reporting
176 3 Terms and definitions

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

178 apply.

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

180 — ISO Online browsing platform: available at http://www.iso.org/obp
181 — IEC Electropedia: available at http://www.electropedia.org/
182 3.101
183 cochlear implant system
184 CIS

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

186 treat hearing impairment via electrical stimulation of the cochlea
187 3.102
188 auditory brainstem implant system
189 ABIS

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

191 treat hearing impairment via electrical stimulation of the auditory brainstem

192 3.103
193 implant system
194 either COCHLEAR IMPLANT SYSTEM or AUDITORY BRAINSTEM IMPLANT SYSTEM
195 3.104
196 non-implantable part
197 external part of the IMPLANT SYSTEM
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198 Note 1 to entry Examples would include, but are not limited to, sound processor, microphone, coil or power

199 source.
200 3.105
201 stimulator

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

203 stimulation
204 3.106
205 body-worn

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

207 3.107
208 electrode contact

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

210 3.108
211 electrode array
212 DISTAL part of a LEAD containing more than one ELECTRODE CONTACT
213 3.109
214 reference electrode

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

216 3.110
217 distal
218 located away from the point of attachment to the STIMULATOR
219 3.111
220 proximal
221 located closest to the point of attachment to the STIMULATOR
222 3.112
223 model designation

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

225 or type, one device from another
226 3.113
227 serial number

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

229 device from other devices with the same MODEL DESIGNATION
230 3.114
231 output signal

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

233 pathways
234 3.115
235 pulse

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

237 3.116
238 biphasic pulse
239 PULSE which has both negative and positive going phases
240 3.117
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241 use-before-date

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

243 3.118
244 magnet
245 component producing an external magnetic flux
246 3.119
247 SAR value
248 SAR = Specific Absorption Rate
249 3.120
250
251 Radio Frequency
252 4 Symbols and abbreviations

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.

255 5 General requirements for non-implantable parts
256 5.1 This subclause of ISO 14708-1 applies.
257 5.2 This subclause of ISO 14708-1 applies.
258 5.3 This subclause of ISO 14708-1 applies.
259 5.4 This subclause of ISO 14708-1 applies.
260 5.5 This subclause of ISO 14708-1 applies.
261 5.6 This subclause of ISO 14708-1 applies.
262 Additional subclauses:

263 5.7 Protection against external electrical hazards for fully implantable systems

264 Clause 6.5 of ANSI/AAMI CI86:2017 applies.
265 6 Inspection and measurement

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.

268 6.1 Measurement of output signal characteristics
269 Clause 8.1 of ANSI/AAMI CI86:2017 applies.
270 6.2 Measurement of the output SIGNAL amplitude and pulse width
271 Clause 8.2 of ANSI/AAMI CI86:2017 applies
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272 6.3 Impedance measurement accuracy
273 Clause 8.3 of ANSI/AAMI CI86:2017 applies.
274 6.4 Inductive link characterization
275 Clause 8.4 of ANSI/AAMI CI86:2017 applies.
276 6.5 Sound processor battery testing
277 Clause 8.5 of ANSI/AAMI CI86:2017 applies.
278 7 General arrangement of the packaging
279 7.1 This subclause of ISO 14708-1 applies.
280 7.2 This subclause of ISO 14708-1 applies.
281 8 General markings for active implantable medical devices
282 8.1 This subclause of ISO 14708-1 applies.
283 8.2 This subclause of ISO 14708-1 applies.
284 9 Markings on the SALES PACKAGING
285 9.1 This subclause of ISO 14708-1 applies.
286 9.2 This subclause of ISO 14708-1 applies except as follows:
287 Replacement:

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.

291 Compliance is checked by inspection.
292 9.3 Replacement

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

295 number and, if applicable the batch number or the serial number.
296 Compliance is checked by inspection.
297 9.4 This subclause of ISO 14708-1 applies.
298 9.5 This subclause of ISO 14708-1 applies.
299 9.6 This subclause of ISO 14708-1 applies.
300 9.7 Replacement
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301 The SALES PACKAGING of implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall bear the USE-

302 BEFORE-DATE, as expressed in 9.6.
303 Compliance shall be checked by inspection.
304 9.8 This subclause of ISO 14708-1 applies.
305 9.9 This subclause of ISO 14708-1 applies.
306 9.10 This subclause of ISO 14708-1 applies.
307 9.11 This subclause of ISO 14708-1 applies.
308 9.12 This subclause of ISO 14708-1 applies.
309 9.13 This subclause of ISO 14708-1 applies.
310 9.14 This subclause of ISO 14708-1 applies.
311 10 Construction of the SALES PACKAGING
312 10.1 This subclause of ISO 14708-1 applies.
313 10.2 This subclause of ISO 14708-1 applies.
314 10.3 This subclause of ISO 14708-1 applies.
315 Additional note:

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

317 Clause 9 need not to be subjected to the test specified in 10.3.
318 10.4 This subclause of ISO 14708-1 applies.
319 11 Markings on the sterile pack
320 11.1 This subclause of ISO 14708-1 applies.
321 11.2 This subclause of ISO 14708-1 applies.
322 11.3 This subclause of ISO 14708-1 applies.
323 11.4 This subclause of ISO 14708-1 applies.
324 11.5 This subclause of ISO 14708-1 applies.
325 11.6 This subclause of ISO 14708-1 applies.
326 11.7 This subclause of ISO 14708-1 applies.
327 11.8 This subclause of ISO 14708-1 applies.
328 11.9 This subclause of
...