EN ISO 14708-5:2022

Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)

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 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.
Included in the scope of this document are:
—     ventricular assist devices (VAD), left or right heart support;
—     total artificial hearts (TAH);
—     biventricular assist devices (biVAD);
—     percutaneous assist devices;
—     paediatric assist devices.

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: Dispositifs d'assistance circulatoire (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

• Status: Published
• Publication Date: 26-Jul-2022
• Withdrawal Date: 30-Jan-2023
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/CLC/JTC 16 - CEN/CENELEC Joint Working Group on Active Implantable Medical Devices
• Drafting Committee: CEN/CLC/JTC 16 - CEN/CENELEC Joint Working Group on Active Implantable Medical Devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 27-Jul-2022
• Completion Date: 27-Jul-2022
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 14708-5:2022 - Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)

Standards Content (Sample)

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

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.
Contents Page
European foreword . 3

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.
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
ISO 14708-5:2020(E)
© 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
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Published in Switzerland
ii © ISO 2020 – All rights reserved

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 .
...