National foreword

This British Standard is the UK implementation of EN ISO 14708‑3:2022. It is identical to ISO 14708‑3:2017.

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 on 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 the following URL: www.iso.org/iso/foreword.html.

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

This second edition cancels and replaces the first edition (ISO 14708‑3:2008), which has been technically revised.

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

Introduction

This document specifies particular requirements for active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708‑1:2014, hereinafter referred to as ISO 14708‑1.

The requirements of this document take priority over those of ISO 14708‑1.

Devices that use electricity to stimulate the nervous system are commonly called “neurostimulators.” They produce controlled electrical pulses that are delivered through electrodes in contact with a specific target area. Whether or not a neurostimulator is totally or partially implantable, a lead or extension is usually required to convey stimulation pulses from a form of pulse generator to the electrodes, although newer forms of devices might not utilize leads or extensions. An external programmer might be used to adjust device parameters.

Currently, several types of neurostimulators exist for treating the central or peripheral nervous system. This document is intended to apply to these neurostimulator types regardless of therapy.

This document is relevant to all parts and accessories of implantable neurostimulators, including programmers, software, and technical manuals. Not all parts or accessories might be intended to be totally or partially implanted, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance intended by the manufacturer.

Not included in the scope of this document are non-implantable medical devices, such as external neurostimulators and RF-coupled neurostimulators, even though such devices might have implantable parts, because they are covered under the IEC 60601‑1 series of standards.

Within this document, the following terms are used to amend and supplement ISO 14708‑1:

“Replacement”: the clause of ISO 14708‑1 is replaced completely by the text of this document.

“Addition”: the text of this document is additional to the requirements of ISO 14708‑1.

“Amendment”: the clause of ISO 14708‑1 is amended as indicated by the text of this document.

“Not used”: the clause of ISO 14708‑1 is not applied in this document.

Subclauses, figures, or tables that are additional to those of ISO 14708‑1 are numbered starting from 101; additional annexes are lettered AA, BB, etc.

European foreword

This document (EN ISO 14708‑3:2022) 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 14708‑3:2017 has been approved by CEN-CENELEC as EN ISO 14708‑3:2022 without any modification.

1 Scope

This document is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.

The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products.

2 Normative references

3 Terms and definitions

4 Symbols and abbreviated terms

5 General requirements for active implantable medical devices

5.101 Wireless coexistence and wireless quality of service

6 Requirements for particular active implantable medical devices

7 General arrangement of the packaging

8 General markings for active implantable medical devices

9 Markings on the sales packaging

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 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

17 Protection from harm to the patient caused by heat

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

19 Protection from unintended effects caused by the active implantable medical device

20 Protection of the active implantable medical device from damage caused by external defibrillators

21 Protection of the active implantable medical device from changes caused by electrical fields applied directly to the patient

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

23 Protection of the active implantable medical device from mechanical forces

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

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-ionizing radiation

27.101 General

27.102 Test conditions

27.103 Risk management and test report documentation

27.104 Protection from static magnetic fields of flux density up to 50 mT

27.105 Protection from EM disturbances over the frequency range 16,6 Hz to 80 MHz

27.105.2 Radiated magnetic field test for frequencies 1 kHz to 150 kHz

27.106 Protection from EM disturbances over the frequency range 80 MHz to 2,7 GHz

27.107 Protection from proximity fields due to RF wireless communications equipment

28 Accompanying documentation

28.104

28.105

Bibliography

BS EN ISO 14708-3:2022

Implants for surgery. Active implantable medical devices - Implantable neurostimulators

Current, Under Review

Published:

31 Aug 2022