kSIST FprEN ISO 14708-5:2020

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

Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 5: Appareils annexes circulatoires (ISO/FDIS 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/FDIS 14708-5:2020)

General Information

• Status: Not Published
• Public Enquiry End Date: 31-Mar-2019
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: I11 - Imaginarni 11
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 16-Jan-2020
• Due Date: 05-Mar-2020
• Completion Date: 21-Feb-2020
• 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: FprEN ISO 14708-5 - Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO/FDIS 14708-5:2020)

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 14708-5:2019
01-marec-2019

9VDGNLLPSODQWDWL]DNLUXUJLMR$NWLYQLPHGLFLQVNLSULSRPRþNL]DYVDGLWHYGHO

1DSUDYH]DSRGSRURFLUNXODFLMH,62',6

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
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Published in Switzerland
ii © ISO 2019 – All rights reserved
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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

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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

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

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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
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
...