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ISO 14708-1:2014

(Main)

Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

ISO 14708-1:2014 specifies requirements that are generally applicable to active implantable medical devices. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an active implantable medical device to show compliance. ISO 14708-1:2014 is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs). ISO 14708-1:2014 is also applicable to some non-implantable parts and accessories of the active implantable medical devices.

Implants chirurgicaux — Dispositifs médicaux implantables actifs — Partie 1: Exigences générales pour la sécurité, le marquage et pour les informations à fournir par le fabricant

General Information

Status
Published
Publication Date
10-Aug-2014
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
ISO/TC 150/SC 6 - Active implants
Drafting Committee
ISO/TC 150/SC 6 - Active implants
Current Stage
9092 - International Standard to be revised
Start Date
12-Dec-2023
Completion Date
19-Apr-2025
Ref Project

Relations

Revises
ISO 14708-1:2000 - Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Effective Date
04-Feb-2009
ISO 14708-1:2014 - Implants for surgery -- Active implantable medical devicesISO 14708-1:2014 - Implants for surgery -- Active implantable medical devices
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Standards Content (Sample)


DRAFT INTERNATIONAL STANDARD ISO/DIS 14708-1
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on Voting terminates on

2013-04-22 2013-07-22
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION

Implants for surgery — Active implantable medical devices —
Part 1:
General requirements for safety, marking and for information to
be provided by the manufacturer
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 1: Exigences générales pour la sécurité, le marquage et pour les informations à fournir par le fabricant
[Revision of first edition (ISO 14708-1:2000)]
ICS 11.040.40
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.

THIS DOCUMENT IS A DRAFT CIRCULATED 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 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 NATIONAL REGULATIONS.
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.
©  International Organization for Standardization, 2013

ISO/DIS 14708-1
©  ISO 2013
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 the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved

DRAFT INTERNATIONAL STANDARD ISO/DIS 14708-1
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on Voting terminates on

2013-04-22 2013-07-22
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION

Implants for surgery — Active implantable medical devicesr —
Part 1:
General requirements for safety, marking and for information to
be provided by the manufacturer
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 1: Exigences générales pour la sécurité, le marquage et pour les informations à fournir par le fabricant
[Revision of first edition (ISO 14708-1:2000)]
ICS 11.040.40
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.

THIS DOCUMENT IS A DRAFT CIRCULATED 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 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 NATIONAL REGULATIONS.
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.
©  International Organization for Standardization, 2013

ISO/DIS 147-8-1
©  ISO 2013
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 the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved

ISO/DIS 14708-1
Contents Page
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviations (optional) . 7
5 General requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES . 7
6 Requirements for particular ACTIVE IMPLANTABLE MEDICAL DEVICES . 9
7 General arrangement of the packaging . 9
8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES . 10
9 MARKINGS on the SALES PACKAGING . 10
10 Construction of the SALES PACKAGING . 12
11 Markings on the STERILE PACK . 12
12 Construction of the NON-REUSABLE PACK . 13
13 Markings on the ACTIVE IMPLANTABLE MEDICAL DEVICE . 14
14 Protection from unintentional biological effects being caused by the ACTIVE IMPLANTABLE
MEDICAL DEVICE . 15
15 Protection from HARM to the patient or user caused by external physical features of the
ACTIVE IMPLANTABLE MEDICAL DEVICE . 17
16 Protection from HARM to the patient caused by electricity . 17
17 Protection from HARM to the patient caused by heat . 18
18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE
MEDICAL DEVICE . 18
19 Protection from unintended effects caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE . 19
20 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by external
defibrillators . 20
21 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by electrical
fields applied directly to the patient . 23
22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by
miscellaneous medical treatments . 24
23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces. 25
24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic
discharge . 27
25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmospheric
pressure changes . 27
26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by temperature
changes . 27
ISO/DIS 14708-1
27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from electromagnetic non-ionizing
radiation . 28
28 Accompanying documentation . 29
Annex A (informative) General guidance and rationale . 33
Annex B (informative) Relationship between the fundamental principles in ISO/TR 14283:2004 and the
clauses of this standard . 44
Bibliography . 62

Figures
Figure 1 – Damped sinus defibrillation waveform . 21
Figure 2 – Defibrillation test voltage generator . 21
Figure 3 – Timing sequence used for Test 1 and Test 2 . 22
Figure 4 – Test setup for truncated exponential DEFIBRILLATION waveform . 22
Figure 5 – Biphasic DEFIBRILLATION waveform for Test 2 . 23
Figure A.1 – RLC implementation for generating a damped sinus defibrillation waveform . 39
Figure A.2 – Positioning and scanning the ultrasound field exposure upon the implantable part . 41
Tables
Table 1 – Timing parameters of test signal for Test 2 . 22

iv © ISO 2013 – All rights reserved

ISO/DIS 14708-1
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 14708-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6,
Active implants in collaboration with the CEN/CENELEC Joint Working Group on active implantable medical
devices.
This second edition cancels and replaces the first edition, which has been technically revised.
ISO 14708 consists of the following parts, under the general title Implants for surgery — Active implantable
medical devices:
 Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
 Part 2: Cardiac pacemakers
 Part 3: Implantable neurostimulators
 Part 4: Implantable infusion pumps
 Part 5: Circulatory support devices
 Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia
(including implantable defibrillators)
 Part 7: Particular requirements for cochlear implant systems
ISO/DIS 14708-1
Introduction
This International Standard specifies general requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES to provide
basic assurance of safety for both patients and users.
To minimize the likelihood of a device being misused, this standard also details
...


INTERNATIONAL ISO
STANDARD 14708-1
Second edition
2014-08-15
Implants for surgery — Active
implantable medical devices —
Part 1:
General requirements for safety,
marking and for information to be
provided by the manufacturer
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 1: Exigences générales pour la sécurité, le marquage et pour les
informations à fournir par le fabricant
Reference number
©
ISO 2014
© ISO 2014
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
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviations (optional) . 7
5 General requirements for active implantable medical devices .7
5.1 General requirements for non-implantable parts . 7
5.2 General requirements for software . 7
5.3 Usability of non-implantable parts . 7
5.4 Data security and protection from harm caused by unauthorized information tampering 8
5.5 General requirements for risk management . 8
5.6 Misconnection of parts of the active implantable medical device . 9
6 Requirements for particular active implantable medical devices .9
7 General arrangement of the packaging . 9
8 General markings for active implantable medical devices. 9
9 Markings on the sales packaging .10
10 Construction of the sales packaging.11
11 Markings on the sterile pack .12
12 Construction of the non-reusable pack.13
13 Markings on the active implantable medical device .13
14 Protection from unintentional biological effects being caused by the active implantable
medical device .14
15 Protection from harm to the patient or user caused by external physical features of the
active implantable medical device .16
16 Protection from harm to the patient caused by electricity .16
17 Protection from harm to the patient caused by heat .17
17.1 Protection from harm to the patient caused by heat .17
17.2 Active implantable medical device intended to supply heat .17
18 Protection from ionizing radiation released or emitted from the active implantable
medical device .17
19 Protection from unintended effects caused by the active implantable medical device .17
20 Protection of the active implantable medical device from damage caused by
external defibrillators .19
21 Protection of the active implantable medical device from changes caused by electrical
fields applied directly to the patient.23
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments .23
23 Protection of the active implantable medical device from mechanical forces.24
24 Protection of the active implantable medical device from damage caused by
electrostatic discharge .26
25 Protection of the active implantable medical device from damage caused by
atmospheric pressure changes .26
26 Protection of the active implantable medical device from damage caused by
temperature changes .26
27 Protection of the active implantable medical device from electromagnetic non-
ionizing radiation .27
28 Accompanying documentation .28
Annex A (informative) General guidance and rationale .32
Annex B (informative) Relationship between the fundamental principles in ISO/TR 14283:2004
and the clauses of this part of ISO 14708 .43
Bibliography .56
iv © ISO 2014 – All rights reserved

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 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 Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 6,
Active implants.
This second edition cancels and replaces the first edition (ISO 14708-1:2000), which has been technically
revised.
ISO 14708 consists of the following parts, under the general title Implants for surgery — Active implantable
medical devices:
— Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
— Part 2: Cardiac pacemakers
— Part 3: Implantable neurostimulators
— Part 4: Implantable infusion pumps
— Part 5: Circulatory support devices
— Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia
(including implantable defibrillators)
— Part 7: Particular requirements for cochlear implant systems
NOTE The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing
organizations might need a transitional period following publication of a new, amended, or revised ISO publication
in which to make products in accordance with the new requirements and to equip them for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication not be adopted for
mandatory implementation nationally earlier than three years from the date of publication.
Introduction
This part of ISO 14708 specifies general requirements for active implantable medical devices to
provide basic assurance of safety for both patients and users.
To minimize the likelihood of a device being misused, this part of ISO 14708 also details comprehensive
requirements for markings and for other information to be supplied as part of the documentation with
any active implantable medical device.
For particular types of active implantable medical device, the general requirements can be
supplemented or modified by the requirements of other parts of ISO 14708. A requirement of a particular
part of ISO 14708 takes priority over the corresponding requirement of this general part of ISO 14708.
Where particular parts of ISO 14708 exist, this general part of ISO 14708 is not intended to be used alone.
Special care is required when applying this general part of ISO 14708 alone to active implantable
medical devices for which no particular International Standard has yet been published.
vi © ISO 2014 – All rights reserved

INTERNATIONAL STANDARD ISO 14708-1:2014(E)
Implants for surgery — Active implantable medical
devices —
Part 1:
General requirements for safety, marking and for
information to be provided by the manufacturer
1 Scope
This part of ISO 14708 specifies requirements that are generally applicable to active implantable
medical devices.
NOTE 1 For particular types of active implantable medical devices, these general requirements are
supplemented or modified by the requirements of particular parts of ISO 14708.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an active
implantable medical device to show compliance.
This part of ISO 14708 is applicable not only to active implantable medical devices that are electrically
powered but also to those powered by other energy sources (for example by gas pressure or by springs).
This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the active
...

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ISO/TR 21900:2018(Main)
Guidance for uncertainty analysis regarding the application of ISO/TS 10974

This document provides guidance for some methods that could be used to evaluate the sources of uncertainty. It is important to note that there are many legitimate methods for analyzing the overall uncertainty and that the methods in this document are illustrative only.

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    14 pages
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ISO
ISO/TS 10974:2018(Main)
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

ISO/TS 10974:2018 is applicable to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who undergo a magnetic resonance scan in 1,5 T, cylindrical (circular or elliptical cross-section) bore, whole body MR scanners operating at approximately 64 MHz with whole body coil excitation. NOTE 1 Requirements for non-implantable parts are outside the scope of this document. The tests that are specified in this document are type tests that characterize interactions with the magnetic and electromagnetic fields associated with an MR scanner. The tests can be used to demonstrate device operation according to its MR Conditional labelling. The tests are not intended to be used for the routine testing of manufactured products. NOTE 2 Modification of these tests for particular device types is left to particular product committees. NOTE 3 Other interested parties, such as device manufacturers, regulatory agencies, and particular product committees, are responsible for setting specific compliance criteria and determining risk. NOTE 4 Safety requirements for MR scanners can be found in IEC 60601‑2‑33. NOTE 5 The scope is limited to AIMDs that do not use sensing functions or to AIMDs that are programmed not to use sensing functions to affect therapy delivery during an MR scan.

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    214 pages
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ISO
ISO 14708-3:2017(Main)
Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators

ISO 14708-3:2017 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.

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  • Standard
    57 pages
    French language
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