kSIST prEN ISO 14708-3:2017

SLOVENSKI STANDARD
oSIST prEN ISO 14708-3:2015
01-november-2015

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

Should this draft be accepted, a final draft, established on the basis of comments

All rights reserved. Unless otherwise specified, 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 below or ISO’s member body in the country of

Foreword .......................................................................................................................................................................... 5

Introduction..................................................................................................................................................................... 6

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

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

3 Terms and definitions .............................................................................................................................................. 7

4 Symbols (and abbreviated terms)........................................................................................................................ 8

5 General requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES .................................................................. 8

6 Requirements for particular ACTIVE IMPLANTABLE MEDICAL DEVICES ............................................................. 8

7 General arrangement of the packaging .............................................................................................................. 8

8 General markings for ACTIVE IMPLANTABLE MEDICAL DEVICES ........................................................................... 9

9 Markings on the sales packaging .......................................................................................................................... 9

10 Construction of the sales packaging ................................................................................................................. 9

11 Markings on the sterile pack ............................................................................................................................... 9

12 Construction of the non-reusable pack ........................................................................................................... 9

13 Markings on the ACTIVE IMPLANTABLE MEDICAL DEVICE .................................................................................... 9

14 Protection from unintentional biological effects being caused by the ACTIVE IMPLANTABLE

MEDICAL DEVICE .................................................................................................................................................................. 9

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

IMPLANTABLE MEDICAL DEVICE ......................................................................................................................................... 9

16 Protection from harm to the patient caused by electricity ...................................................................... 9

17 Protection from harm to the patient caused by heat .................................................................................. 9

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

device .............................................................................................................................................................................. 10

19 Protection from unintended effects caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE ............... 10

20 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by external

defibrillators ................................................................................................................................................................ 11

21 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by electrical fields

applied directly to the patient ............................................................................................................................... 11

22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by miscellaneous

medical treatments .................................................................................................................................................... 11

23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces ................................ 12

24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic

discharge ........................................................................................................................................................................ 13

25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmospheric

pressure changes ........................................................................................................................................................ 13

26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by temperature

changes ........................................................................................................................................................................... 13

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

radiation ........................................................................................................................................................................ 13

28 Accompanying documentation ................................................................................................................. 24

Annex AA (normative) Relationship between the fundamental principles in ISO/TR 14283 and

the clauses of this part of ISO 14708.................................................................................................................... 26

Annex BB (informative) Rationale ....................................................................................................................... 35

Annex CC (informative) Guidance — Test plan ................................................................................................ 45

Bibliography ................................................................................................................................................................. 46

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

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

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

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

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

assessment, as well as information about ISO's adherence to the WTO principles in the Technical

This second edition cancels and replaces the first edition (ISO 14708-3:2008), which has been

ISO 14708 consists of the following parts, under the general title Implants for surgery — Active

— Part 1: General requirements for safety, marking and for information to be provided by the

— Part 6: Particular requirements for active implantable medical devices intended to treat

This part of ISO 14708 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,

The requirements of this part of ISO 14708 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

Currently, several types of neurostimulators exist for treating the central or peripheral nervous system.

This part of ISO 14708 is intended to apply to these neurostimulator types regardless of therapy.

This part of ISO 14708 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

Within this part of ISO 14708 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 part of ISO 14708.

“Addition”: the text of this part of ISO 14708 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 part ISO 14708.

Subclauses, figures, or tables that are additional to those of ISO 14708-1 are numbered starting from

This part of ISO 14708 is applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES intended for electrical

The tests that are specified in this part of ISO 14708 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

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

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

ISO 14117:2012, Active implantable medical devices — Electromagnetic compatibility — EMC test

protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac

ISO 14708-1:2014, Implants for surgery — Active implantable medical devices — Part 1: General

requirements for safety, marking and for information to be provided by the manufacturer

ISO/TS 10974:— , Assessment of the safety of magnetic resonance imaging for patients with an active

IEC 60601-1:2005+A1:2012, Medical electrical equipment — Part 1: General requirements for basic

IEC 60601-1-2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and

essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests

IEC 61000-4-3:2006+A1:2007+A2:2010, Electromagnetic compatibility (EMC) — Part 4-3: Testing and

measurement techniques — Radiated, radio-frequency, electromagnetic field immunity test

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

active implantable medical device intended for electrical stimulation of the central or peripheral

Note 1 to entry For purposes of this part of ISO 14708, an implantable neurostimulator can be a single article, or

a system consisting of a set of components and accessories which interact to achieve the performance intended by

the manufacturer. Not all of these components or accessories might be required to be partially or totally

part of an implantable neurostimulator (INS), consisting of a power source and electronic circuit, which

period after implantation when the implantable neurostimulator remains within stated specifications

When communication with the implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE is provided

through wireless communication channels, the MANUFACTURER shall evaluate wireless coexistence and

wireless quality of service through the RISK MANAGEMENT PROCESS and apply the appropriate RISK CONTROL

In the absence of external influence, an implantable part of the INS, not intended to supply heat to the

patient, shall comply with at least one of the following conditions (a, b or c) when implanted, and

NOTE Examples of external influences include exposure to MRI, electrosurgery, external defibrillation,

b) no tissue receives a thermal dose greater than the CEM43 dose thresholds in Table 101; or

c) manufacturer’s evidence that a higher temperature rise, than indicated in Table 101, is justified for

Because the values in Table 101 represent tissue dose thresholds, the manufacturer’s risk assessment

shall include an analysis of any effects to the patient due to the time/temperature relationship.

T is the average temperature of the tissue in degrees Centigrade during the interval t ;

Compliance is checked by inspection of a design analysis provided by the manufacturer, supported by

NOTE 1 This clause does not apply to devices that are not labeled MR CONDITIONAL.

Implantable parts of an INS and any non-implantable components and accessories, which are labeled MR

CONDITIONAL, shall be designed and constructed so that no irreversible change to the device or

Assessment: For an implantable part of an INS intended to be used in patients who undergo a

magnetic resonance scan in 1,5 T, cylindrical bore, whole body MR scanners, the requirements of

ISO/TS 10974 shall apply. For non-implantable components and accessories, or as an alternative for

implantable parts, the manufacturer may demonstrate safety using similar or equivalent means.

NOTE 2 Other MR environments will require manufacturer evaluation by similar or other means.

The outcome of each test shall not result in an unacceptable risk to the patient. Additional acceptance

If device samples are used for testing, they shall meet all manufacturer specifications after testing is

Compliance is checked by inspection of test reports and the risk management file.

RF field-induced heating TBD after ED2 RF induced heating of adjacent tissue(s) shall not cause an

of the AIMD is published unacceptable risk. This heating value shall be below a limit

Gradient field-induced TBD after ED2 Gradient induced heating of adjacent tissue(s) shall not cause an

device heating is published unacceptable risk. This heating value shall be below a limit

Gradient field-induced TBD after ED2 Gradient induced vibration shall not cause an unacceptable risk.

is published device or less than a greater specified value that is supported by a

B -induced torque TBD after ED2 Magnetically induced torque shall be less than the worst case

RF field induced lead TBD after ED2 Induced lead voltages shall not cause an unacceptable risk.

Gradient field induced TBD after ED2 Induced lead voltages shall not cause an unacceptable risk.

B field induced device TBD after ED2 Device malfunction shall not cause an unacceptable risk.

RF field induced device TBD after ED2 Device malfunction shall not cause an unacceptable risk.

Gradient field induced TBD after ED2 Device malfunction shall not cause an unacceptable risk.

Combined fields TBD after ED2 The combined fields test outcome shall not result in an

Following the test, the non-implantable part of the active implantable medical device shall operate as

NOTE While the electrostatic discharge is applied only to the non-implantable parts, operation of the ACTIVE

Implantable parts of the implantable neurostimulator (INS) are expected to maintain their intended use

and shall not result in an unacceptable risk because of susceptibility to electrical influences due to

Assessment: The tests of this clause shall be used to assess device behavioural responses when exposed

NOTE 1 The tests in this clause apply only to the implantable parts. Non-implantable parts are covered by IEC