FprEN ISO 14708-4

SLOVENSKI STANDARD
oSIST prEN ISO 14708-4:2020
01-junij-2020

Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 4. del:

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion

Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 4 : Systèmes de

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

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

Foreword ..........................................................................................................................................................................................................................................v

Introduction ..............................................................................................................................................................................................................................vii

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Symbols and abbreviated terms ........................................................................................................................................................... 3

5 General requirements for active implantable medical devices ........................................................................... 3

5.1 General requirements for non-implantable parts .................................................................................................... 3

5.2 General requirements for software ....................................................................................................................................... 3

5.3 Usability of non-implantable parts ........................................................................................................................................ 3

5.4 Data security and protection from harm caused by unauthorized information tampering 3

5.5 General requirements for risk management ................................................................................................................. 3

5.6 Misconnection of parts of the active implantable medical device .............................................................. 3

6 Requirements for particular active implantable medical devices ................................................................... 4

6.1 Implantable infusion pump system specifications .................................................................................................. 4

6.2 Septum puncture test ........................................................................................................................................................................ 4

7 General arrangement of the packaging ........................................................................................................................................ 5

8 General markings for active implantable medical devices ...................................................................................... 5

9 Markings on the sales packaging ......................................................................................................................................................... 6

10 Construction of the sales packaging ................................................................................................................................................. 6

11 Markings on the sterile pack.................................................................................................................................................................... 6

12 Construction of the non-reusable pack ......................................................................................................................................... 7

13 Markings on the active implantable medical device ....................................................................................................... 7

14 Protection from unintentional biological effects caused by the active implantable

medical device......................................................................................................................................................................................................... 7

15 Protection from harm to the patient or user caused by external physical features of

the active implantable medical device .......................................................................................................................................... 8

16 Protection from harm to the patient caused by electricity ...................................................................................... 8

17 Protection from harm to the patient caused by heat ...................................................................................................... 8

18 Protection from ionizing radiation released or emitted from the active implantable

medical device......................................................................................................................................................................................................... 9

19 Protection from unintended effects caused by the active implantable medical device .............9

external defibrillators .................................................................................................................................................................................... 9

21 Protection of the active implantable medical device from changes caused by high-

power electrical fields applied directly to the patient ...............................................................................................10

miscellaneous medical treatments ................................................................................................................................................10

23 Protection of the active implantable medical device from mechanical forces .................................11

electrostatic discharge ................................................................................................................................................................................12

atmospheric pressure changes ...........................................................................................................................................................12

temperature changes ....................................................................................................................................................................................12

ionizing radiation .............................................................................................................................................................................................12

27.1 General ........................................................................................................................................................................................................12

27.2 Test conditions .....................................................................................................................................................................................12

27.2.1 Acceptance criteria .....................................................................................................................................................12

27.2.2 Test configuration ........................................................................................................................................................13

27.2.3 Operating functions, modes, and settings ...............................................................................................13

27.3 Documentation ....................................................................................................................................................................................13

27.4 Protection from static magnetic fields of flux density up to 50 mT .......................................................14

27.5 Protection from magnetic fields over the frequency range 16 Hz to 26 MHz ................................14

27.6 Protection from EM disturbances over the frequency range 80 MHz to 2,7 GHz .......................16

27.7 Protection from proximity fields due to RF wireless communications equipment ..................17

27.8 Optional characterization testing ........................................................................................................................................17

28 Accompanying documentation ...........................................................................................................................................................18

ISO/TR 14283 and the clauses of this document .......................................................................................................20

Annex B (informative) Rationale ...........................................................................................................................................................................40

Annex C (informative) Guidance on the allocation of requirements to non-implantable

parts connected to a power source .................................................................................................................................................49

Annex Z (informative) A Relationship between this European standard and the General

covered ......... ................................................................................................................................................................................................................56

Bibliography .............................................................................................................................................................................................................................67

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

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

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

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

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO's adherence to the WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, SC 6, Active

This second edition cancels and replaces the first edition (ISO 14708-4:2008), which has been

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

This document specifies particular requirements for active implantable medical devices intended

to deliver a medicinal substance to site-specific locations within the human body, to provide basic

assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The

An implantable infusion pump system is a device that delivers either a constant flow rate or a variable

flow rate from which a medicinal substance is delivered via an implanted catheter to site-specific

locations within the human body. An external programmer might be used to adjust device parameters.

Requirements for physiologic sensing functions of implantable infusion pump systems are not included in

This document is applicable to active implantable medical devices intended to deliver medicinal

This document is also applicable to some non-implantable parts and accessories of the devices as

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

a device to show compliance and are not intended to be used for the routine testing of manufactured

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 14708-1:2014, Implants for surgery — Active implantable medical devices — Part 1: General

requirements for safety, marking and for information to be provided by the manufacturer

ISO/TS 10974:2018, Assessment of the safety of magnetic resonance imaging for patients with an active

I EC 6 06 01-1:20 05+A 1: 2012 , Medical electrical equipment — Part 1: General requirements for basic safety

I EC 6 06 01-1-2:2014 +A 1: 2020, Medical electrical equipment — Part 1-2: General requirements for basic

safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements

IEC 61000-4-3:2006, _A1:2007+A2: 2010, Electromagnetic compatibility (EMC) — Part 4–3: Testing and

measurement techniques — Radiated, radio-frequency, electromagnetic field immunity test

For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

specific amount of fluid (dose or volume) delivered once for a prescribed length of time (duration)

internal surfaces of the implantable infusion pump system which are in direct contact with a medicinal

active implantable medical device intended for delivery of a medicinal substance to a specific location

Note 1 to entry: Note to entry: For purposes of this document, an implantable infusion pump system can be a single

article, or a set of components and accessories. Not all of these components or accessories might be required to

an item with demonstrated safety in the MR environment within defined conditions for the static

magnetic field, the time-varying gradient magnetic field and the radiofrequency fields

implantable part of an implantable infusion pump system containing the fluid reservoir, energy source

ability to consistently deliver the same results over time, under the same conditions

Note 1 to entry: Note to entry: A method for calculating repeatability is given in Annex B of ISO 11631 .

period after implantation when the implantable infusion pump system remains within stated

calculated interval between two subsequent reservoir refills to assure stability of the medicinal

The specifications (e.g. infusion accuracy and repeatability) stated by the manufacturer in the

accompanying documentation (see 28.8) shall be maintained over the service life and over the range of

environmental conditions and characteristics (e.g. reservoir volume) stated by the manufacturer.

NOTE Minimum environmental conditions for atmospheric pressure are specified in Clause 25.

Infusion accuracy shall be stated for all selectable rates (including bolus rates).

The manufacturer shall provide a plot of infusion accuracy versus environmental conditions and

characteristics (e.g. reservoir volume) that affect infusion accuracy. For variable rate implantable infusion

pump systems, the plot shall contain curves for minimum rate, maximum rate, and at least one rate in

The method of computing and determining the infusion accuracy shall be clearly stated in the

accompanying documentation. Environmental test conditions used to establish infusion accuracy shall

also be stated. Environmental conditions and characteristics that affect infusion accuracy shall be

For all selectable infusion rates, the repeatability of the actual rate shall also be stated. The method

of computing and determining the stated repeatability shall be clearly described in the accompanying

Compliance is checked by inspection of accompanying documentation and test procedures and reports,

A septum that allows entry to an access port (e.g. refill access port or catheter access port), shall be able

to withstand repeated insertions of a hypodermic needle while maintaining the integrity of the fluid

Test: The DUT shall be conditioned at 37 °C ± 1 °C for not less than 12 h to achieve thermal equilibration.

Each pump septum shall be punctured randomly using the needle specified by the manufacturer for

septum puncture and in accordance with the manufacturer’s instructions. The needle used for septum

puncture shall be replaced if damage to the needle or the needle’s tip is noted by the operator. The

needle shall completely penetrate the septum and care should be taken not to damage the needle’s tip

during the test. Puncturing shall be done using a straight-line motion parallel to the septum's axial

Septum leakage shall be determined by immersing the test unit in a water bath at 37 °C ± 1 °C and

allowing the temperature of the assembly to stabilize for a minimum of 30 min. Leakage shall be

determined by air pressure applied slowly to a pressure of twice the pump’s maximum operating

pressure or a minimum of 276 kPa. The septum’s exposed surfaces shall be examined for air bubble

The maximum number of punctures for which the septum maintains integrity shall be stated (see 28.8).

8.3 If special handling measures have to be taken during transport, the shipping packaging shall be

8.4 The permissible environmental conditions for transport shall be marked on the outside of the