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)
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.
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 4: Implantierbare Infusionspumpensysteme (ISO 14708-4:2022)
Dieses Dokument legt die für aktive implantierbare medizinische Geräte, die zur Verabreichung einer medizinischen Substanz an wirkortspezifischen Stellen innerhalb des menschlichen Körpers vorgesehen sind, geltenden Anforderungen fest, um sowohl für Patienten als auch Anwender für eine Sicherstellung der Grundsicherheit zu sorgen. Es ändert und ergänzt ISO 14708-1:2014. Die Anforderungen dieses Dokuments haben gegenüber denen der ISO 14708-1 Vorrang.
Dieses Dokument ist anwendbar für aktive implantierbare medizinische Geräte, die zur Verabreichung von medizinischen Substanzen an wirkortspezifischen Stellen innerhalb des menschlichen Körpers vorgesehen sind.
Dieses Dokument ist auch anwendbar 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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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 14708-4:2022(E)
© 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 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 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 . 1
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.