National foreword

This British Standard is the UK implementation of EN ISO 14708‑7:2022. It is identical to ISO 14708‑7:2019.

The UK participation in its preparation was entrusted to Technical Committee CH/150/2, Cardiovascular implants.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2022.

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 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 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6, Active implants.

This second edition cancels and replaces the first edition (ISO 14708‑7:2013), which has been technically revised. The main changes compared to the previous edition are as follows:

alignment to the revised ISO 14708‑1:2014;
significant changes to Clauses 17, 22 and 27;
many clauses have been replaced by references to ANSI/AAMI CI86:2017.

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

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

This corrected version of ISO 7063:2018 incorporates the following correction: in 16.2, the word "direct" was added in the following sentence: "The maximum direct current density at the electrode contact opening shall be no more than 0,75 μA/mm²".

Introduction

This document specifies particular requirements for active implantable medical devices 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 users.

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 can be externally derived or from an internal battery. The implant system is designed to restore hearing via 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 document is relevant to all parts of implant systems, including accessories.

The requirements of this document supplement or modify those of ISO 14708‑1:2014.

In this document, terms printed in italic letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italic letters unless the concept thus qualified is also defined.

Information is also provided in Annex B that explains the relationship between ISO/TR 14283, ISO 14708‑1:2014 and this document.

Notes on EN 45502‑2‑3 (basis for this document) is provided in Annex C for information.

This European Standard was approved by CEN on 6 July 2022.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

European foreword

This document (EN ISO 14708‑7:2022) has been prepared by Technical Committee ISO/TC 150 "Implants for surgery" in collaboration with Technical Committee CEN-CENELEC/ JTC 16 “Active Implantable Medical Devices” the secretariat of which is held by DKE.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2023, and conflicting national standards shall be withdrawn at the latest by January 2023.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.

Any feedback and questions on this document should be directed to the users’ national standards body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC websites.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United Kingdom.

Endorsement notice

The text of ISO 14708‑7:2019 has been approved by CEN-CENELEC as EN ISO 14708‑7:2022 without any modification.

1 Scope

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.

2 Normative references

3 Terms and definitions

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

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

9.1

9.2

9.3

9.4

9.5

9.6

9.7

10 Construction of the sales packaging

10.1

10.2

10.3

11 Markings on the sterile pack

11.1

11.2

12 Construction of the non-reusable pack

12.1

12.2

12.3

13 Markings on the active implantable medical device

13.1

13.2

13.3

13.4

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

14.1

14.2

14.3

14.4

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

15.1

15.2

16 Protection from harm to the patient caused by electricity

16.1

16.2

16.3

16.4 Charge and charge density limits for biphasic, charge-balanced pulses

16.5 Phase duration requirements

16.6 Stimulation waveform requirements

17 Protection from harm to the patient caused by heat

17.1

17.2

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

18.1

18.2

18.3

19 Protection from unintended effects caused by the device

19.1

19.2

19.3

19.4

19.5

19.6

19.7

19.8

19.9 Implantable device internal moisture content

20 Protection of the device from damage caused by external defibrillators

20.1

20.2

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

21.1

21.2

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

22.1

22.2

22.3

23 Protection of the active implantable medical device from mechanical forces

23.1

23.2

23.3

23.4

23.5

23.6

23.7

23.8

23.9

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

24.1

24.2

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

25.1

25.2

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

26.1

26.2

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

27.3 Radiated electric field test for frequencies 10 MHz to 2,7 GHz

27.4 General test configuration and setup

27.5 Acceptance Criteria

28 Accompanying documentation

28.1

28.2

28.3

28.4

28.5

28.6

28.7

28.8

28.9

28.10

28.11

28.12

28.13

28.14

28.15

28.16

28.17

28.18

28.19

28.20

28.21

28.22

28.23

28.24

28.25

28.26

28.27

28.28

28.29

28.30

Bibliography

BS EN ISO 14708-7:2022

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

Current

Published:

31 Aug 2022