National foreword

This British Standard is the UK implementation of EN ISO 14708‑2:2022. It is identical to ISO 14708‑2:2019. It supersedes BS ISO 14708‑2:2012, which is withdrawn.

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.

ISO 14708‑2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6, Active implants.

This third edition cancels and replaces the second edition ( ISO 14708‑2:2012), which has been technically revised.

The main changes compared to the previous edition are as follows:

addition of requirements for congestive heart failure devices;
introduction of nomenclature for devices having more than two channels of pacing / sensing as shown in ISO 14117:2019, Annex N;
revision of the method for measurement of pulse amplitude and pulse duration in 6.1.2;
removal of measurement requirements for input impedance in 6.1.4;
inclusion of new temporary exposure criteria in 17.1 for outer surface temperatures exceeding 39 °C. Other changes include updates to selected definitions and incorporation of new measurement equipment accuracy requirements.

A list of all parts 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.

Introduction

This document specifies particular requirements for those active implantable medical devices intended to treat bradyarrhythmias (pacemakers), to provide basic assurance of safety to both patients and users.

In recent years, other active implantable cardiovascular devices have emerged, most notably devices that perform the function of improving cardiac output by optimizing ventricular synchrony, in addition to performing pacemaker functions.

Although these devices can deliver an additional therapy with respect to pacemakers, most of their requirements are similar so that, in most cases, the concepts that apply to pacemakers also apply to CRT-P device, and the appropriate way to test a CRT-P device is similar to the way pacemakers are tested.

An implantable cardiac pacemaker is essentially a powered electronic device within a sealed, encapsulating enclosure (an implantable pulse generator). The device can stimulate heart beats by generating electrical impulses which are transmitted to the heart along implanted, insulated conductors with electrodes (leads). The pacemaker can be adjusted non-invasively by an electronic device, known as a programmer.

This document is relevant to all parts of implantable pacemakers, including all accessories. Typical examples are implantable pulse generators, leads, adaptors, programmers and the related software.

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

Although both this document and the Directive 90/385/EEC deal with the same products, the structure and purpose of the two documents are different. Annex A correlates the requirements of the Directive with the subclauses of ISO 14708‑1 and this document. Annex B is a rationale providing further explanation of the subclauses of this document.

Annex C describes a coding system that may be used to designate bradyarrhythmia pacing modes. Annex D defines reference points for measurements of pulse amplitude and pulse duration, and the form of test signal used to determine sensitivity.

All annexes except Annex D are informative.

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

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 14708‑2:2022) 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 14708‑2:2019 has been approved by CEN-CENELEC as EN ISO 14708‑2:2022 without any modification.

1 Scope

This document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.

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 was designed for bradyarrhythmia pulse generators used with endocardial leads or epicardialleads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.

This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).

The electrical characteristics of the implantable pulse generator or lead are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies.

Any features of an active implantable medical device intended to treat tachyarrhythmias are covered by ISO 14708‑6.

NOTE 1 The 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, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.

2 Normative references

3 Terms and definitions

4 Symbols and abbreviated terms

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

6 Measurements of implantable pulse generator and lead characteristics

6.1 Measurement of implantable pulse generator characteristics

6.2 Measurement of the lead pacing impedance (Z_p)

7 General arrangement of the packaging

7.1

7.2

8 General markings for active implantable medical devices

8.1

8.2

9 Markings on the sales packaging

9.1

9.2

9.3

9.4

9.5

9.6

9.7

9.8

9.9

9.10

9.11

9.12

9.13

9.14

10 Construction of the sales packaging

10.1

10.2

10.3

10.4

11 Markings on the sterile pack

11.1

11.2

11.3

11.4

11.5

11.6

11.7

11.8

11.9

11.10

11.11

12 Construction of the non-reusable pack

12.1

12.2

12.3

13 Markings on the active implantable medical device

13.1

13.1.1

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

17 Protection from harm to the patient caused by heat

17.1 Protection from harm to the patient caused by heat

17.2 Active implantable medical device intended to supply heat

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

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

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

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-ionizing radiation

27.1

27.2

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 14708-2:2022

Implants for surgery. Active implantable medical devices - Cardiac pacemakers

Current

Published:

31 Aug 2022