SIST EN ISO 14708-5:2022
(Main)Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
ISO 14708-5:2010 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraint devices and counter-pulsation devices, such as extra- or intra-aortic balloon pumps.
ISO 14708-5:2010 specifies type tests, animal studies and clinical evaluation requirements.
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 5: Besondere Anforderungen an Kreislaufunterstützungssysteme (ISO 14708-5:2020)
Dieses Dokument legt Anforderungen an die Sicherheit und Leistung aktiver implantierbarer Kreislaufunterstützungsgeräte
einschließlich von Typprüfungen, Tierversuchen und Anforderungen an die klinische
Bewertung fest.
ANMERKUNG Bei dem üblicherweise als aktives implantierbares medizinisches Gerät bezeichneten Gerät kann es
sich in der Realität um ein einzelnes Gerät, eine Gerätekombination oder eine Kombination aus einem Gerät oder
mehreren Geräten und einem oder mehreren Zubehörteilen handeln. Bei nicht allen diesen Teilen ist eine teilweise oder
vollständige Implantierbarkeit gefordert; es ist jedoch erforderlich, die wichtigsten Anforderungen an nicht implantierbare
Teile und Zubehörteile festzulegen, sofern diese die Sicherheit oder die Leistung des implantierbaren Geräts
beeinträchtigen könnten.
Die in diesem Dokument festgelegten Prüfungen sind Typprüfungen und müssen an einem Prüfling eines
Geräts durchgeführt werden, um das Betriebsverhalten des Geräts zu beurteilen, sind jedoch nicht dafür
vorgesehen, zur Stückprüfung der hergestellten Produkte angewendet zu werden.
Zum Anwendungsbereich dieses Dokuments gehören:
– ventrikuläre Unterstützungsgeräte (VAD), Links- oder Rechtsherzunterstützung;
– totaler Herzersatz (TAH);
– biventrikuläre Unterstützungsgeräte (biVAD);
– perkutane Unterstützungsgeräte;
– pädiatrische Unterstützungsgeräte.
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 5: Appareils annexes circulatoires (ISO 14708-5:2020)
Le présent document spécifie les exigences relatives à la sécurité et aux performances des dispositifs d'assistance circulatoire implantables actifs, y compris les exigences des essais de type, des études sur les animaux et des évaluations cliniques.
NOTE Le dispositif couramment appelé dispositif médical implantable actif peut en fait être un dispositif unique, une combinaison de dispositifs, ou une combinaison d'un ou de plusieurs dispositifs avec un ou plusieurs accessoires. Il n'est pas nécessaire que toutes ces pièces soient partiellement ou totalement implantables, mais il est nécessaire de spécifier les exigences principales des parties et accessoires non implantables s'ils peuvent avoir une influence sur la sécurité ou les performances du dispositif implantable.
Les essais qui sont spécifiés dans le présent document sont des essais de type et doivent être effectués sur un échantillon du dispositif afin d'évaluer les réactions comportementales du dispositif, et ne sont pas destinés à être utilisés pour les essais de routine sur les produits manufacturés.
Les éléments suivants sont inclus dans le domaine d'application du présent document:
— les dispositifs d'assistance ventriculaire (DAV), une assistance ventriculaire droite ou gauche;
— les cœurs totalement artificiels (TAH);
— les dispositifs d'assistance biventriculaire (biVAD);
— les dispositifs d'assistance percutanée;
— les dispositifs d'assistance pédiatrique.
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 5. del: Naprave za podporo cirkulacije (ISO 14708-5:2020)
Standard ISO 14708-5:2010 določa zahteve glede varnosti in delovanja aktivnih naprav za podporo cirkulacije, namenjenih vsaditvi. Ne uporablja se za zunajtelesne pripomočke za perfuzijo, kardiomioplastiko, zadrževanje srca in pripomočke za ECP-terapijo, kot so ekstraaortne ali intraaortne balonske črpalke.
Standard ISO 14708-5:2010 določa zahteve za tipske preskuse, študije na živalih in klinično vrednotenje.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14708-5:2022
01-oktober-2022
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 5. del:
Naprave za podporo cirkulacije (ISO 14708-5:2020)
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support
devices (ISO 14708-5:2020)
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 5: Besondere
Anforderungen an Kreislaufunterstützungssysteme (ISO 14708-5:2020)
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 5: Appareils
annexes circulatoires (ISO 14708-5:2020)
Ta slovenski standard je istoveten z: EN ISO 14708-5:2022
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 14708-5:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 14708-5:2022
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SIST EN ISO 14708-5:2022
EUROPEAN STANDARD EN ISO 14708-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2022
ICS 11.040.40
English version
Implants for surgery - Active implantable medical devices -
Part 5: Circulatory support devices (ISO 14708-5:2020)
Implants chirurgicaux - Dispositifs médicaux Chirurgische Implantate - Aktive implantierbare
implantables actifs - Partie 5: Dispositifs d'assistance medizinische Geräte - Teil 5: Besondere
circulatoire (ISO 14708-5:2020) Anforderungen an Kreislaufunterstützungssysteme
(ISO 14708-5:2020)
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.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2022 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 14708-5:2022 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO 14708-5:2022
EN ISO 14708-5:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 14708-5:2022
EN ISO 14708-5:2022 (E)
European foreword
This document (EN ISO 14708-5:2022) 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.
This document has been prepared under a Standardization Request given to CEN and CENELEC by the
European Commission and the European Free Trade Association.
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 14708-5:2020 has been approved by CEN-CENELEC as EN ISO 14708-5:2022 without
any modification.
3
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SIST EN ISO 14708-5:2022
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SIST EN ISO 14708-5:2022
INTERNATIONAL ISO
STANDARD 14708-5
Second edition
2020-05
Implants for surgery — Active
implantable medical devices —
Part 5:
Circulatory support devices
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 5: Dispositifs d'assistance circulatoire
Reference number
ISO 14708-5:2020(E)
©
ISO 2020
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SIST EN ISO 14708-5:2022
ISO 14708-5:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 14708-5:2022
ISO 14708-5:2020(E)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviations . 5
5 General requirements for active implantable medical devices . 5
5.1 General requirements for non-implantable parts . 5
5.2 General requirements for software . 5
5.3 Usability of non-implantable parts . 5
5.4 Data security and protection from harm caused by unauthorized information tampering 6
5.5 General requirements for risk management . 6
5.6 Misconnection of parts of the active implantable medical device . 6
5.7 Wireless coexistence and wireless quality of service . 6
6 Requirements for particular active implantable medical devices . 6
6.1 Intended clinical use/indications . 6
6.2 System description . 6
6.2.1 General. 6
6.2.2 System configuration . 8
6.2.3 System performance and operating limits . 8
6.3 Design analysis . 8
6.3.1 General. 8
6.3.2 Human factors analysis . 8
6.4 Risk analysis . 9
6.5 Human factors .10
6.6 In vitro design evaluation and system performance testing .10
6.6.1 Objective . .10
6.6.2 System characterization .10
6.6.3 Subsystem component testing .13
6.7 Electromagnetic compatibility .17
6.8 Materials qualification .17
6.9 Biocompatibility .18
6.10 Dynamic haemolysis.18
6.11 Environmental testing .18
6.12 In vivo evaluation .18
6.12.1 Objective . .18
6.12.2 Definition of success or failure .19
6.12.3 Test articles . .19
6.12.4 Test system .19
6.12.5 Control .20
6.12.6 Test equipment .20
6.12.7 Preoperative animal care .20
6.12.8 Implant procedure.20
6.12.9 Special instructions for early termination .20
6.12.10 Postoperative care .21
6.12.11 Anticoagulation .21
6.12.12 Adverse events .21
6.12.13 System performance .21
6.12.14 Measurement of physiological parameters .21
6.12.15 Clinical pathology .21
6.12.16 Necropsy and device retrieval .21
6.12.17 Macroscopic examination .22
© ISO 2020 – All rights reserved iii
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SIST EN ISO 14708-5:2022
ISO 14708-5:2020(E)
6.12.18 Histological examination .22
6.12.19 Explanted device analysis .22
6.12.20 Data analysis .22
6.13 Reliability .22
6.14 Clinical evaluation .23
7 General arrangement of the packaging .23
8 General markings for active implantable medical devices .24
9 Markings on the sales packaging .24
10 Construction of the sales packaging .24
11 Markings on the sterile pack.24
12 Construction of the non-reusable pack .25
13 Markings on the active implantable medical device .25
14 Protection from unintentional biological effects being caused by the active
implantable medical device .25
15 Protection from harm to the patient or user caused by external physical features of
the active implantable medical device .26
16 Protection from harm to the patient caused by electricity .26
17 Protection from harm to the patient caused by heat .26
17.1 Protection from harm to the patient caused by heat .26
17.2 Active implantable medical device intended to supply heat .26
18 Protection from ionizing radiation released or emitted from the active implantable
medical device.26
19 Protection from unintended effects caused by the active implantable medical device .26
20 Protection of the active implantable medical device from damage caused by
external defibrillators .27
21 Protection of the active implantable medical device from changes caused by
electrical fields applied directly to the patient .27
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments .27
23 Protection of the active implantable medical device from mechanical forces .28
24 Protection of the active implantable medical device from damage caused by
electrostatic discharge .28
25 Protection of the active implantable medical device from damage caused by
atmospheric pressure changes .28
26 Protection of the active implantable medical device from damage caused by
temperature changes .28
27 Protection of the active implantable medical device from electromagnetic non-
ionizing radiation .29
27.1 General .29
27.2 Test conditions .29
27.2.1 Acceptance criteria .29
27.2.2 Test configuration and setup .29
27.2.3 Operating functions, modes, and settings .30
27.2.4 Patient physiological simulation .30
27.2.5 Immunity test levels.30
27.3 Risk management file and test report file documentation .30
27.4 Protection from static magnetic fields of flux density up to 50 mT .31
27.5 Protection from AC magnetic fields in the range of 1 kHz to 140 kHz .31
iv © ISO 2020 – All rights reserved
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SIST EN ISO 14708-5:2022
ISO 14708-5:2020(E)
27.6 Protection from proximity fields due to RF wireless communications equipment .32
28 Accompanying documentation .32
Annex A (informative) Relationship between the fundamental principles in ISO/TR 14283
and the clauses of this document .36
Annex B (informative) Rationale .55
Annex C (informative) Pre-clinical in vitro/in silico evaluation .61
Annex D (informative) Active implantable medical device hazards, associated failure
modes, and evaluation methods.65
Bibliography .67
© ISO 2020 – All rights reserved v
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SIST EN ISO 14708-5:2022
ISO 14708-5:2020(E)
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 14708-5:2010), which has been technically
revised. The main change compared to the previous edition is as follows:
— alignment to the revised ISO 14708-1:2014.
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.
vi © ISO 2020 – All rights reserved
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SIST EN ISO 14708-5:2022
ISO 14708-5:2020(E)
Introduction
This document specifies requirements for safety and performance of active implantable circulatory
support devices. 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.
Heart failure is a major public health problem. It is estimated that worldwide more than 5 million
people die per year due to heart failure. In addition, it accounts for a large portion of health care
expenditure and rehospitalisation (see Reference [35]). Circulatory support devices are needed
for promoting myocardial recovery following acute heart failure as well as long-term support until
eventual transplantation or permanent therapy. Circulatory support devices may be fully implanted,
partially implanted, or delivered by percutaneous approach. The growth of heart failure is expected to
increase with the aging population (see Reference [30]).
The requirements of this document supplement or modify those of ISO 14708-1.
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.
Information is also provided in Annex A that explains the relationship between ISO/TR 14283,
ISO 14708-1 and this document.
Notes on this document are provided in Annex B for information.
Annex C provides guidance on pre-clinical in vitro and in silico evaluation. Annex D provides information
device hazards, associated failure modes, and evaluation methods. All annexes are informative.
© ISO 2020 – All rights reserved vii
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SIST EN ISO 14708-5:2022
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SIST EN ISO 14708-5:2022
INTERNATIONAL STANDARD ISO 14708-5:2020(E)
Implants for surgery — Active implantable medical
devices —
Part 5:
Circulatory support devices
1 Scope
This document specifies requirements for safety and performan
...
SLOVENSKI STANDARD
oSIST prEN ISO 14708-5:2019
01-marec-2019
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Implants for surgery - Active implantable medical devices - Part 5: Circulatory support
devices (ISO/DIS 14708-5:2019)
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 5: Besondere
Anforderungen an Kreislaufunterstützungssysteme (ISO/DIS 14708-5:2019)
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 5: Appareils
annexes circulatoires (ISO/DIS 14708-5:2019)
Ta slovenski standard je istoveten z: prEN ISO 14708-5
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14708-5:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 14708-5:2019
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oSIST prEN ISO 14708-5:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14708-5
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-01-08 2019-04-02
Implants for surgery — Active implantable medical
devices —
Part 5:
Circulatory support devices
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 5: Appareils annexes circulatoires
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
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
ISO/CEN PARALLEL PROCESSING
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14708-5:2019(E)
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. ISO 2019
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oSIST prEN ISO 14708-5:2019
ISO/DIS 14708-5:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 14708-5:2019
ISO/DIS 14708-5:2019(E)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviations . 7
5 General requirements for active implantable medical devices .7
6 Requirements for particular active implantable medical devices .7
6.101 Intended clinical use/indications . 7
6.102 System description . 7
6.102.1 General. 7
6.102.2 System configuration . 9
6.102.3 System performance and operating limits . 9
6.103 Design analysis . 9
6.103.1 Human factors analysis . 9
6.104 Risk analysis .10
6.105 Human factors .11
6.106 In vitro design evaluation and system performance testing .11
6.106.1 Objective . .11
6.106.2 System characterization .11
6.106.3 Subsystem component testing .14
6.107 Electromagnetic compatibility .18
6.108 Materials qualification .19
6.109 Biocompatibility .19
6.110 Dynamic haemolysis.19
6.111 Environmental testing .19
6.112 In vivo evaluation .20
6.112.1 Objective . .20
6.112.2 Definition of success or failure .20
6.112.3 Test articles . .20
6.112.4 Test system .20
6.112.5 Test equipment .21
6.112.6 Preoperative animal care .21
6.112.7 Implant procedure.21
6.112.8 Special instructions for early termination .22
6.112.9 Postoperative care .22
6.112.10 .
Anticoagulation .22
6.112.11 .
Adverse events .22
6.112.12 .
System performance .22
6.112.13 .
Measurement of physiological parameters .22
6.112.14 .
Clinical pathology .22
6.112.15 .
Necropsy and device retrieval .23
6.112.16 .
Macroscopic examination .23
6.112.17 .
Histological examination .23
© ISO 2019 – All rights reserved iii
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oSIST prEN ISO 14708-5:2019
ISO/DIS 14708-5:2019(E)
6.112.18 .
Explanted device analysis .23
6.112.19 .
Data analysis .23
6.113 Reliability .24
6.113.1 Clinical evaluation.25
7 General arrangement of the packaging .25
8 General markings for active implantable medical devices.25
9 Markings on the sales packaging .25
10 Construction of the sales packaging.25
11 Markings on the sterile pack.25
12 Construction of the non-reusable pack .25
13 Markings on the active implantable medical device .25
13.101 Visual indications.25
14 Protection from unintentional biological effects being caused by the active
implantable medical device .25
15 Protection from harm to the patient or user caused by external physical features of
the active implantable medical device.26
16 Protection from harm to the patient caused by electricity .26
17 Protection from harm to the patient caused by heat .26
18 Protection from ionizing radiation released or emitted from the active implantable
medical device.26
19 Protection from unintended effects caused by the active implantable medical device .26
19.101 Power supply .26
19.101.1 .
Power supply redundancy .26
19.101.2 .
Power supply management .26
20 Protection of the active implantable medical device from damage caused by
external defibrillators .27
21 Protection of the active implantable medical device from changes caused by
electrical fields applied directly to the patient .27
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments .27
23 Protection of the active implantable medical device from mechanical forces.27
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
27 Protection of the active implantable medical device from electromagnetic non-
ionizing radiation .27
27.101 General .28
27.102 Test conditions .28
27.102.1 .
Acceptance criteria .28
iv © ISO 2019 – All rights reserved
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oSIST prEN ISO 14708-5:2019
ISO/DIS 14708-5:2019(E)
27.102.2 .
Test configuration and setup .28
27.102.3 .
Operating functions, modes and settings .29
27.102.4 .
Patient physiological simulation .29
27.102.5 .
Immunity test levels.29
27.103 Risk management file and test report file documentation .29
27.104 Protection from static magnetic fields of flux density up to 50 mT .30
27.105 Protection from AC magnetic fields in the range of 1 kHz to 140 kHz .30
27.106 Protection from proximity fields due to RF wireless communications equipment .31
28 Accompanying documentation .31
28.101 Instructions for use .31
28.102 Patient ID card .32
28.103 Wireless documentation .33
Annex AA (informative) Relationship between the fundamental principles in ISO/
[6]
TR 14283 and the clauses of this document .34
Annex BB (informative) Rationale .52
Annex CC (informative) Pre-clinical in vitro / in silico evaluation .58
Annex DD (informative) Active implantable medical device hazards, associated failure
modes, and evaluation methods.62
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . .64
Bibliography .73
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oSIST prEN ISO 14708-5:2019
ISO/DIS 14708-5:2019(E)
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 14708-5:2010), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— alignment to the revised ISO 14708-1:2014
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.
vi © ISO 2019 – All rights reserved
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oSIST prEN ISO 14708-5:2019
ISO/DIS 14708-5:2019(E)
Introduction
This document specifies requirements for safety and performance of active implantable circulatory
support devices. 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.
Heart failure (HF) is a major public health problem. It is estimated that worldwide more than
5 million people die per year due to heart failure. In addition, it accounts for a large portion of health
care expenditure and rehospitalisation (AHA [24]). Circulatory support devices are needed for
promoting myocardial recovery following acute heart failure as well as long-term support until eventual
transplantation or permanent therapy. Circulatory support devices may be fully implanted, partially
implanted, or delivered by percutaneous approach. The growth of heart failure is expected to increase
with the aging population (Koelling TM et al,[19]).
The requirements of this document supplement or modify those of ISO 14708-1, Implants for surgery —
Active implantable medical devices — Part 1: General requirements for safety, marking and for information
to be provided by the manufacturer.
Figures or tables that are additional to those of Part 1 are numbered starting from 101; additional
annexes are lettered AA, BB, etc.
In this document, terms printed in small capital 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 small capital letters unless the concept
thus qualified is also defined.
Information is also provided in Annex AA that explains the relationship between ISO/TR 14283,
Implants for surgery — Essential principles of safety and performance, ISO 14708-1 and this document.
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oSIST prEN ISO 14708-5:2019
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oSIST prEN ISO 14708-5:2019
DRAFT INTERNATIONAL STANDARD ISO/DIS 14708-5:2019(E)
Implants for surgery — Active implantable medical
devices —
Part 5:
Circulatory support devices
1 Scope
This document specifies requirements for safety and performance of active implantable circulatory
support devices, including type tests, animal studies and clinical evaluation requirements.
NOTE 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 main
requirements of non-implantable parts and accessories if they could affect the safety or performance of the
implantable device.
The tests that are specified in document are type tests and are to be carried out on a sample of a device
to assess device behavioural responses and are not intende
...
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