FprEN ISO 14708-5

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

Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 5: Besondere

Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 5: Appareils

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

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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

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

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

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

external defibrillators .................................................................................................................................................................................27

electrical fields applied directly to the patient ..................................................................................................................27

miscellaneous medical treatments ................................................................................................................................................27

23 Protection of the active implantable medical device from mechanical forces............................27

electrostatic discharge ................................................................................................................................................................................27

atmospheric pressure changes ...........................................................................................................................................................27

temperature changes ....................................................................................................................................................................................27

ionizing radiation .............................................................................................................................................................................................27

27.101 General ........................................................................................................................................................................................................28

27.102 Test conditions .....................................................................................................................................................................................28

27.102.1 ........................................................................................................................................................

Acceptance criteria .....................................................................................................................................................28

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

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

covered ......... ................................................................................................................................................................................................................64

Bibliography .............................................................................................................................................................................................................................73

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

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committee has been established has the right to be represented on that committee. International

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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

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any patent rights identified during the development of the document will be in the Introduction and/or

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

For an explanation 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

This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee

This second edition cancels and replaces the first edition (ISO 14708-5:2010), which has been technically

Any feedback or questions on this document should be directed to the user’s national standards body. A

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.

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

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

Figures or tables that are additional to those of Part 1 are numbered starting from 101; additional

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

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.

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

The tests that are specified in document are type tests and are to be carried out on a sample of a device