SIST EN ISO 14708-4:2022
(Main)Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
ISO 14708-4:2008 is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body.
ISO 14708-4:2008 is also applicable to some non-implantable parts and accessories of the devices.
The tests that are specified in ISO 14708-4:2008 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 products.
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 4: Implantierbare Infusionspumpen (ISO 14708-4:2022)
Dieses Dokument gilt für aktive implantierbare medizinische Geräte, die zur Verabreichung von medizinischen Substanzen an wirkortspezifischen Stellen innerhalb des menschlichen Körpers vorgesehen sind.
Dieses Dokument gilt auch für einige nicht implantierbare Teile und Zubehörteile der Geräte, wie in Abschnitt 3 definiert.
Die in diesem Dokument festgelegten Prüfungen sind Typprüfungen und sollen an einem Prüfling eines Geräts durchgeführt werden, um die Einhaltung der Anforderungen offenzulegen, sind jedoch nicht dafür vorgesehen, zur Stückprüfung der hergestellten Produkte angewendet zu werden.
ANMERKUNG Dieses Dokument ist nicht dafür vorgesehen, für nicht implantierbare Infusionssysteme zu gelten.
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 4: Systèmes de pompe à perfusion implantables (ISO 14708-4:2022)
Le présent document spécifie des exigences particulières concernant les dispositifs médicaux implantables actifs, destinés à délivrer une substance médicamenteuse en des sites spécifiques du corps humain, afin de garantir la sécurité de base des patients et des utilisateurs. Il modifie et complète l'ISO 14708-1:2014. Les exigences du présent document sont prioritaires sur celles de l'ISO 14708-1.
Le présent document s'applique aux dispositifs médicaux implantables actifs destinés à délivrer des substances médicamenteuses en des sites spécifiques du corps humain.
Le présent document est également applicable à certaines parties et certains accessoires non implantables des dispositifs, tels que définis à l'Article 3.
Les essais spécifiés dans le présent document sont des essais de type destinés à être réalisés sur un échantillon d'un dispositif pour en démontrer la conformité, et n'ont pas vocation à être utilisés pour les essais de routine sur les produits manufacturés.
NOTE Le présent document n'a pas pour objet d'être appliqué aux systèmes de perfusion non implantables.
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 4. del: Sistemi za vsadljive infuzijske črpalke (ISO 14708-4:2022)
Standard ISO 14708-4:2008 se uporablja za aktivne medicinske pripomočke za vsaditev, namenjene dovajanju zdravilnih učinkovin do specifičnih mest v človeškem telesu.
Standard ISO 14708-4:2008 se uporablja tudi za nekatere dele in dodatno opremo pripomočkov, ki niso namenjeni vsaditvi.
Preskusi, določeni v standardu ISO 14708-4:2008, so tipski preskusi, ki jih je treba za dokaz skladnosti opraviti na vzorcih pripomočka in niso namenjeni za rutinsko preskušanje proizvedenih izdelkov.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14708-4:2022
01-oktober-2022
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 4. del:
Sistemi za vsadljive infuzijske črpalke (ISO 14708-4:2022)
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion
pump systems (ISO 14708-4:2022)
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 4:
Implantierbare Infusionspumpen (ISO 14708-4:2022)
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 4: Systèmes de
pompe à perfusion implantables (ISO 14708-4:2022)
Ta slovenski standard je istoveten z: EN ISO 14708-4:2022
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 14708-4:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 14708-4:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 14708-4:2022
EUROPEAN STANDARD EN ISO 14708-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2022
ICS 11.040.40
English version
Implants for surgery - Active implantable medical devices -
Part 4: Implantable infusion pump systems (ISO 14708-
4:2022)
Implants chirurgicaux - Dispositifs médicaux Chirurgische Implantate - Aktive implantierbare
implantables actifs - Partie 4: Systèmes de pompe à medizinische Geräte - Teil 4: Implantierbare
perfusion implantables (ISO 14708-4:2022) Infusionspumpen (ISO 14708-4:2022)
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 14708-4:2022 E
reserved worldwide for CEN national Members and for
CENELEC Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 14708-4:2022
EN ISO 14708-4:2022 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 14708-4:2022
EN ISO 14708-4:2022 (E)
European foreword
This document (EN ISO 14708-4:2022) 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.
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 14708-4:2022 has been approved by CEN-CENELEC as EN ISO 14708-4:2022 without
any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 14708-4:2022
---------------------- Page: 6 ----------------------
SIST EN ISO 14708-4:2022
INTERNATIONAL ISO
STANDARD 14708-4
Second edition
2022-02
Implants for surgery — Active
implantable medical devices —
Part 4:
Implantable infusion pump systems
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 4: Systèmes de pompe à perfusion implantables
Reference number
ISO 14708-4:2022(E)
© ISO 2022
---------------------- Page: 7 ----------------------
SIST EN ISO 14708-4:2022
ISO 14708-4:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 14708-4:2022
ISO 14708-4:2022(E)
Contents Page
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 .3
6.1 Implantable infusion pump system specifications . 3
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 .7
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
20 Protection of the active implantable medical device from damage caused by
external defibrillators .10
21 Protection of the active implantable medical device from changes caused by high-
power electrical fields applied directly to the patient .10
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments .10
22.1 Diagnostic ultrasound . 10
22.2 Magnetic resonance imaging . 10
23 Protection of the active implantable medical device from mechanical forces .11
24 Protection of the active implantable medical device from damage caused by
electrostatic discharge.12
iii
© ISO 2022 – All rights reserved
---------------------- Page: 9 ----------------------
SIST EN ISO 14708-4:2022
ISO 14708-4:2022(E)
25 Protection of the active implantable medical device from damage caused by
atmospheric pressure changes . .12
26 Protection of the active implantable medical device from damage caused by
temperature changes .12
27 Protection of the active implantable medical device from electromagnetic non-
ionizing radiation.12
27.1 General .12
27.2 Test conditions . 13
27.2.1 Acceptance criteria . 13
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 .15
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 . 18
28 Accompanying documentation .18
Annex A (informative) Relationship between the fundamental principles in ISO/TR 14283
and the clauses of this document .21
Annex B (informative) Rationale .42
Annex C (informative) Guidance on the allocation of requirements to non-implantable
parts connected to a power source .51
Bibliography .58
iv
© ISO 2022 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 14708-4:2022
ISO 14708-4:2022(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, SC 6, Active
implants, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/JTC 16, Active implantable medical devices, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 14708-4:2008), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— the title of this document has been modified;
— 9.4 additions have been deleted;
— 11.101 has been deleted;
— 14.2 replacement has been deleted;
— 14.101 has been deleted;
— 14.5 has been added;
— Clause 17 has been revised;
— 19.2 replacement has been deleted;
— 19.3 replacement has been deleted;
— 19.101 has been deleted;
— 19.7 has been added;
— 23.2 amendment has been deleted;
v
© ISO 2022 – All rights reserved
---------------------- Page: 11 ----------------------
SIST EN ISO 14708-4:2022
ISO 14708-4:2022(E)
— Clause 27 has been revised;
— 28.8 additions have been deleted;
— 28.10 additions have been deleted;
— 28.12 addition has been deleted;
— 28.101 through 28.103 has been deleted;
— 28.31 and 28.32 has been added.
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 2022 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 14708-4:2022
ISO 14708-4:2022(E)
Introduction
An implantable infusion pump system is a device that delivers either a constant infusion rate or a variable
infusion 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 edition of this document but might be considered in future editions.
vii
© ISO 2022 – All rights reserved
---------------------- Page: 13 ----------------------
SIST EN ISO 14708-4:2022
---------------------- Page: 14 ----------------------
SIST EN ISO 14708-4:2022
INTERNATIONAL STANDARD ISO 14708-4:2022(E)
Implants for surgery — Active implantable medical
devices —
Part 4:
Implantable infusion pump systems
1 Scope
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
requirements of this document take priority over those of ISO 14708-1.
This document is applicable to active implantable medical devices intended to deliver medicinal
substances to site-specific locations within the human body.
This document is also applicable to some non-implantable parts and accessories of the devices defined
in Clause 3.
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
products.
NOTE This document is not intended to apply to non-implantable infusion systems.
2 Normative references
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, 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, Assessment of the safety of magnetic resonance imaging for patients with an active
implantable medical device
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential
performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 61000-4-3, Electromagnetic compatibility (EMC) — Part 4–3: Testing and measurement techniques —
Radiated, radio-frequency, electromagnetic field immunity test
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14708-1 and the following
apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
1
© ISO 2022 – All rights reserved
---------------------- Page: 15 ----------------------
SIST EN ISO 14708-4:2022
ISO 14708-4:2022(E)
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
bolus
specific amount of fluid (dose or volume) delivered once for a prescribed length of time (duration)
3.2
catheter access port
port allowing access to the delivery catheter
3.3
fluid pathway
internal surfaces of the implantable infusion pump system (3.4) which are in direct contact with a
medicinal substance
Note 1 to entry: This also includes catheters and refill kits.
3.4
implantable infusion pump system
active implantable medical device intended for delivery of a medicinal substance to a specific location
within the human body
Note 1 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 be partially
or totally implanted, e.g. programmers.
3.5
infusion rate accuracy
closeness of the true (actual) infusion rate to the programmed rate
3.6
maximum infusion rate
highest rate selectable by the user
3.7
minimum infusion rate
lowest rate selectable by the user
3.8
magnetic resonance conditional
MR conditional
item with demonstrated safety in the MR environment within defined conditions including conditions
for the static magnetic field, the time-varying gradient magnetic fields and the radiofrequency fields
[SOURCE: ASTM F2503-20, 3.1.11]
3.9
pump
implantable part of an implantable infusion pump system (3.4) containing the reservoir (3.12), energy
source and, in some cases, control electronics
3.10
refill access port
port allowing access to the reservoir (3.12)
3.11
repeatability
ability to consistently deliver the same results over time, under the same conditions
Note 1 to entry: A method for calculating repeatability is given in Annex B of ISO 11631:1998.
2
© ISO 2022 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 14708-4:2022
ISO 14708-4:2022(E)
3.12
reservoir
space designed to hold fluid
3.13
reservoir volume
fluid volume of the reservoir (3.12) that can be discharged
3.14
service life
period after implantation when the implantable infusion pump system (3.4) remains within stated
specifications and characteristics
4 Symbols and abbreviated terms
The text in Clause 4 of ISO 14708-1:2014 applies with the following addition:
DUT device under test
5 General requirements for active implantable medical devices
5.1 General requirements for non-implantable parts
The text in 5.1 of ISO 14708-1:2014 applies.
5.2 General requirements for software
The text in 5.2 of ISO 14708-1:2014 applies.
5.3 Usability of non-implantable parts
The text in 5.3 of ISO 14708-1:2014 applies.
5.4 Data security and protection from harm caused by unauthorized information
tampering
The text in 5.4 of ISO 14708-1:2014 applies.
5.5 General requirements for risk management
The text in 5.5 of ISO 14708-1:2014 applies.
5.6 Misconnection of parts of the active implantable medical device
The text in 5.6 of ISO 14708-1:2014 applies.
6 Requirements for particular active implantable medical devices
6.1 Implantable infusion pump system specifications
The specifications (e.g. infusion rate 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.
3
© ISO 2022 – All rights reserved
---------------------- Page: 17 ----------------------
SIST EN ISO 14708-4:2022
ISO 14708-4:2022(E)
Infusion rate accuracy shall be stated for all selectable rates (including bolus rates).
The manufacturer shall provide a plot of infusion rate accuracy versus environmental conditions and
characteristics (e.g. reservoir volume) that affect infusion rate accuracy. For variable rate implantable
infusion pump systems, the plot shall contain curves for minimum infusion rate, maximum infusion rate,
and at least one rate in between the minimum infusion rate and maximum infusion rate.
The method of computing and determining the infusion rate accuracy shall be clearly stated in the
accompanying documentation. Environmental test conditions used to establish infusion rate accuracy
shall also be stated. Environmental conditions and characteristics that affect infusion rate accuracy
shall be clearly stated in the accompanying documentation.
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
documentation.
Compliance is checked by inspection of accompanying documentation and test procedures and reports,
supported by the manufacturer’s calculations, as appropriate.
6.2 Septum puncture test
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
reservoir throughout the service life.
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 u
...
SLOVENSKI STANDARD
oSIST prEN ISO 14708-4:2020
01-junij-2020
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 4. del:
Vsadljive infuzijske črpalke (ISO/DIS 14708-4:2020)
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion
pumps (ISO/DIS 14708-4:2020)
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 4:
Implantierbare Infusionspumpen (ISO/DIS 14708-4:2020)
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 4 : Systèmes de
pompe à perfusion implantables (ISO/DIS 14708-4:2020)
Ta slovenski standard je istoveten z: prEN ISO 14708-4
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14708-4:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 14708-4:2020
---------------------- Page: 2 ----------------------
oSIST prEN ISO 14708-4:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14708-4
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-04-02 2020-06-25
Implants for surgery — Active implantable medical
devices —
Part 4:
Implantable infusion pump systems
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 4: Pompes d'infusion en implant
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 14708-4:2020(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 2020
---------------------- Page: 3 ----------------------
oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(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
---------------------- Page: 4 ----------------------
oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
Contents Page
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
20 Protection of the active implantable medical device from damage caused by
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
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments .10
23 Protection of the active implantable medical device from mechanical forces .11
24 Protection of the active implantable medical device from damage caused by
electrostatic discharge .12
25 Protection of the active implantable medical device from damage caused by
atmospheric pressure changes .12
© ISO 2020 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
26 Protection of the active implantable medical device from damage caused by
temperature changes .12
27 Protection of the active implantable medical device from electromagnetic non-
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
Annex A (informative) Relationship between the fundamental principles in
[4]
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
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . .56
Bibliography .67
iv © ISO 2020 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(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. 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. 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 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
implants.
This second edition cancels and replaces the first edition (ISO 14708-4:2008), which has been
technically revised.
The main changes compared to the previous edition are as follows
— The title was modified,
— 9.4 additions deleted,
— 11.101 deleted,
— 14.2 replacement deleted,
— 14.101 deleted,
— 14.5 added,
— 17 revised,
— 19.2 replacement deleted,
— 19.3 replacement deleted,
— 19.101 deleted,
— 19.7 added,
— 23.2 amendment deleted,
— 27 revised,
— 28.8 additions deleted,
© ISO 2020 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
— 28.10 additions deleted,
— 28.12 addition deleted,
— 28.101 through 28.103 deleted,
— 28.31 and 28.31 added.
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
---------------------- Page: 8 ----------------------
oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
Introduction
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
requirements of document take priority over those of ISO 14708-1.
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 edition of this document but might be considered in future editions.
Annex A, Annex B and Annex C are provided for information only.
© ISO 2020 – All rights reserved vii
---------------------- Page: 9 ----------------------
oSIST prEN ISO 14708-4:2020
---------------------- Page: 10 ----------------------
oSIST prEN ISO 14708-4:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 14708-4:2020(E)
Implants for surgery — Active implantable medical
devices —
Part 4:
Implantable infusion pump systems
1 Scope
This document is applicable to active implantable medical devices intended to deliver medicinal
substances to site-specific locations within the human body.
This document is also applicable to some non-implantable parts and accessories of the devices as
defined in Clause 3.
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
products.
NOTE This document is not intended to apply to non-implantable infusion systems.
2 Normative references
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 14971, Medical devices — Application of risk management to medical devices
ISO/TS 10974:2018, Assessment of the safety of magnetic resonance imaging for patients with an active
implantable medical device
I EC 6 06 01-1:20 05+A 1: 2012 , Medical electrical equipment — Part 1: General requirements for basic safety
and essential performance
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
and tests
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
3 Terms and definitions
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:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
© ISO 2020 – All rights reserved 1
---------------------- Page: 11 ----------------------
oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
3.1
bolus
specific amount of fluid (dose or volume) delivered once for a prescribed length of time (duration)
3.2
catheter access port
port allowing access to the delivery catheter
3.3
fluid pathway
internal surfaces of the implantable infusion pump system which are in direct contact with a medicinal
substance
Note 1 to entry: Note to entry: This also includes catheters and refill kits.
3.4
implantable infusion pump system
active implantable medical device intended for delivery of a medicinal substance to a specific location
within the human body
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
be partially or totally implanted, e.g. programmers.
3.5
infusion accuracy
how close the true (actual) infusion rate is to the programmed rate
3.6
maximum rate
highest rate selectable by the user
3.7
minimum rate
lowest rate selectable by the user
3.8
MR Conditional
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
[SOURCE: ASTM F2503-13, 3.1.11]
3.9
pump
implantable part of an implantable infusion pump system containing the fluid reservoir, energy source
and, in some cases, control electronics
3.10
refill access port
port allowing access to the fluid reservoir
3.11
repeatability
ability to consistently deliver the same results over time, under the same conditions
[1]
Note 1 to entry: Note to entry: A method for calculating repeatability is given in Annex B of ISO 11631 .
3.12
reservoir
a space designed to hold fluid
2 © ISO 2020 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
3.13
reservoir volume
fluid volume of the reservoir that can be discharged
3.14
service life
period after implantation when the implantable infusion pump system remains within stated
specifications and characteristics
3.15
stability interval
calculated interval between two subsequent reservoir refills to assure stability of the medicinal
substance
4 Symbols and abbreviated terms
The text in clause 4 of ISO 14708-1:2014 applies with the following addition:
DUT device under test
5 General requirements for active implantable medical devices
5.1 General requirements for non-implantable parts
The text in 5.1 of ISO 14708-1:2014 applies.
5.2 General requirements for software
The text in 5.2 of ISO 14708-1:2014 applies.
5.3 Usability of non-implantable parts
The text in 5.3 of ISO 14708-1:2014 applies.
5.4 Data security and protection from harm caused by unauthorized information
tampering
The text in 5.4 of ISO 14708-1:2014 applies.
5.5 General requirements for risk management
The text in 5.5 of ISO 14708-1:2014 applies.
5.6 Misconnection of parts of the active implantable medical device
The text in 5.6 of ISO 14708-1:2014 applies.
© ISO 2020 – All rights reserved 3
---------------------- Page: 13 ----------------------
oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
6 Requirements for particular active implantable medical devices
6.1 Implantable infusion pump system specifications
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
between the minimum rate and maximum rate.
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
clearly stated in the accompanying documentation.
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
documentation.
Compliance is checked by inspection of accompanying documentation and test procedures and reports,
supported by the manufacturer’s calculations, as appropriate.
6.2 Septum puncture test
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
reservoir throughout the service life.
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
centre-line as shown in Figure 1.
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
leakage for 1 min.
The maximum number of punctures for which the septum maintains integrity shall be stated (see 28.8).
Compliance is checked by inspection of accompanying documents and test reports.
4 © ISO 2020 – All rights reserved
---------------------- Page: 14 ----------------------
oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
Key
1 needle
2 septum
Figure 1 — Septum puncture test
7 General arrangement of the packaging
7.1 The text in 7.1 of ISO 14708-1:2014 applies.
7.2 The text in 7.2 of ISO 14708-1:2014 applies.
8 General markings for active implantable medical devices
8.1 The text in 8.1 of ISO 14708-1:2014 applies.
8.2 The text in 8.2 of ISO 14708-1:2014 applies.
8.3 If special handling measures have to be taken during transport, the shipping packaging shall be
marked accordingly.
Compliance is checked by inspection.
8.4 The permissible environmental conditions for transport shall be marked on the outside of the
[2]
shipping packaging (see ISO 15223-1 ).
Compliance is checked by inspection.
© ISO 2020 – All rights reserved 5
---------------------- Page: 15 ----------------------
oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
9 Markings on the sales packaging
9.1 The text in 9.1 of ISO 14708-1:2014 applies.
9.2 The text in 9.2 of ISO 14708-1:2014 applies.
9.3 The text in 9.3 of ISO 14708-1:2014 applies.
9.4 The text in 9.4 of ISO 14708-1:2014 applies.
9.5 The text in 9.5 of ISO 14708-1:2014 applies.
9.6 The text in 9.6 of ISO 14708-1:2014 applies.
9.7 The text in 9.7 of ISO 14708-1:2014 applies.
9.8 The text in 9.8 of ISO 14708-1:2014 applies.
9.9 The text in 9.9 of ISO 14708-1:2014 applies.
9.10 The text in 9.10 of ISO 14708-1:2014 applies.
9.11 The text in 9.11 of ISO 14708-1:2014 applies.
9.12 The text in 9.12 of ISO 14708-1:2014 applies.
9.13 The text in 9.13 of ISO 14708-1:2014 applies.
9.14 The text in 9.14 of ISO 14708-1:2014 applies.
10 Construction of the sales packaging
10.1 The text in 10.1 of ISO 14708-1:2014 applies.
10.2 The text in 10.2 of ISO 14708-1:2014 applies.
10.3 The text in 10.3 of ISO 14708-1:2014 applies.
10.4 The text in 10.4 of ISO 14708-1:2014 applies.
11 Markings on the sterile pack
11.1 The text in 11.1 of ISO 14708-1:2014 applies.
11.2 The text in 11.2 of ISO 14708-1:2014 applies.
11.3 The text in 11.3 of ISO 14708-1:2014 applies.
11.4 The text in 11.4 of ISO 14708-1:2014 applies.
6 © ISO 2020 – All rights reserved
---------------------- Page: 16 ----------------------
oSIST prEN ISO 14708-4:2020
ISO/DIS 14708-4:2020(E)
11.5 The text in 11.5 of ISO 14708-1:2014 applies.
11.6 The text in 11.6 of ISO 14708-1:2014 applies.
11.7 The text in 11.7 of ISO 14708-1:2014 applies.
11.8 The text in 11.8 of ISO 14708-1:2014 applies.
11.9 The text in 11.9 of ISO 14708-1:2014 applies.
12 Construction of the non-reusable pack
12.1 The text in 12.1 of ISO 14708-1:2014 applies.
12.2 The text in 12.2 of ISO 14708-
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.