EN ISO 9713:2022

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022)

This document establishes the characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling and accompanying documentation. In addition, it gives a method for the measurement of closing force.
This document is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips).
NOTE       In this document when not otherwise established, the term “implant” refers to the self-closing intracranial aneurysm clips.

Neurochirurgische Implantate - Selbstschließende intrakranielle Aneurysmen-Clips (ISO 9713:2022)

Dieses Dokument legt Kenngrößen von selbstschließenden Aneurysmen-Clips, die für permanente intrakranielle Implantationen bestimmt sind, und die Anforderungen für ihre Kennzeichnung, Verpackung, Sterilisation sowie für Etikettierung und begleitende Dokumentation fest. Zusätzlich enthält diese Norm ein Verfahren für die Messung der Schließkraft.
Dieses Dokument ist nicht anwendbar für formbare Clips oder für Clips, die für die Dauer eines chirurgischen Eingriffs bestimmt sind und vor Wundverschluss entfernt werden (temporäre Clips).
ANMERKUNG   In diesem Dokument bezieht sich der Begriff „Implantat“, wenn nicht anderweitig festgelegt, auf die selbstschließenden intrakraniellen Aneurysmen-Clips.

Implants neurochirurgicaux - Clips intracrâniens pour anévrisme à autofermeture (ISO 9713:2022)

Le présent document établit les caractéristiques des clips pour anévrisme à autofermeture destinés à une implantation intracrânienne permanente et spécifie les exigences pour leur marquage, emballage, stérilisation et étiquetage, ainsi que pour la documentation d’accompagnement. En outre, il donne une méthode pour mesurer la force de fermeture.
Le présent document ne couvre ni les clips malléables, ni les clips prévus pour être utilisés en cours d’opération et retirés avant la fermeture de la plaie (clips temporaires).
NOTE       Dans le présent document, sauf indication contraire, le terme «implant» désigne les clips intracrâniens pour anévrisme à autofermeture.

Nevrokirurški vsadki (implantati) - Samozapiralne sponke za uporabo pri intrakranialnih anevrizmah (ISO 9713:2022)

Ta dokument določa lastnosti samozapiralnih sponk za uporabo pri intrakranialnih anevrizmah, namenjenih za trajno intrakranialno vsaditev, in določa zahteve za njihovo označevanje, pakiranje, sterilizacijo ter za označevanje in spremno dokumentacijo. Poleg tega navaja tudi metodo za merjenje zapiralne sile. Ta dokument se ne uporablja za upogljive sponke ali sponke, ki so namenjene za uporabo med operacijo in jih kirurg pred zaprtjem rane odstrani (začasne sponke). OPOMBA: V tem dokumentu, če ni drugače določeno, se izraz »vsadek« navezuje na samozapiralne sponke za uporabo pri intrakranialnih anevrizmah.

General Information

• Status: Published
• Publication Date: 25-Jan-2022
• Withdrawal Date: 30-Jul-2022
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285 - Non-active surgical implants
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 26-Jan-2022
• Completion Date: 26-Jan-2022
• Ref Project: SIST EN ISO 9713:2022 - Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022)

Relations

• Replaces: EN ISO 9713:2009 - Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)
• Effective Date: 08-Jun-2022

Overview

EN ISO 9713:2022 (identical to ISO 9713:2022) defines requirements for neurosurgical implants in the form of self-closing intracranial aneurysm clips intended for permanent implantation. The standard specifies the characteristics, labelling, packaging, sterilization and accompanying documentation for these clips and provides a uniform method for measuring closing force. It does not apply to malleable clips or temporary clips removed before wound closure. EN ISO 9713:2022 supersedes the 2009 edition and was adopted by CEN in 2022.

Key Topics

• Scope and definitions - clarifies applicability to self-closing permanent intracranial aneurysm clips.
• Description and geometry - terminology for clip mechanism, geometry and blade surfaces.
• Materials - references accepted implant materials and emphasizes material selection for biocompatibility and magnetic behavior.
• MRI safety assessment - guidance to assess clip behavior and image artefacts in magnetic resonance environments.
• Design requirements - including the standardised measurement of closing force, tolerances, possible reduction of force due to actuation, blade surface verification and maximum blade opening.
• Sterilization and supplying condition - requirements for sterilization methods and supplying states, aligned with ISO 14630.
• Packaging and marking - rules to ensure sterility, traceability and safe transport.
• Information for users and patients - labelling, instructions for use, patient card and patient record label requirements to support clinical decision-making and post-implant follow-up.
• Measurement method - a uniform procedure to determine actual closing force so surgeons can compare products consistently.

Applications

EN ISO 9713:2022 is used by:

• Medical device manufacturers designing and producing self-closing intracranial aneurysm clips to meet regulatory and market requirements.
• Quality and regulatory teams preparing technical files, labelling and sterilization validation.
• Test laboratories and R&D groups that perform closing force measurements, MRI safety testing and mechanical verification.
• Hospitals and neurosurgeons choosing appropriate clips based on documented closing force, MRI compatibility and labelling information.
• Notified bodies and conformity assessors evaluating compliance for CE marking and market access in Europe.

Related standards

Relevant referenced documents include:

• ISO 5832 series (implant metallic materials)
• ISO 14630 (non-active surgical implants - general requirements)
• ISO 15223-1 (medical device symbols)
• ISO 17664-1 (processing and sterilization information)

EN ISO 9713:2022 supports safer clinical selection and consistent testing of self-closing intracranial aneurysm clips by standardizing key technical parameters such as closing force, MRI behavior, sterilization and labelling.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2022
Nadomešča:
SIST EN ISO 9713:2009
Nevrokirurški vsadki (implantati) - Samozapiralne sponke za uporabo pri
intrakranialnih anevrizmah (ISO 9713:2022)
Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022)
Neurochirurgische Implantate - Selbstschließende intrakranielle Aneurysmen-Clips (ISO
9713:2022)
Implants neurochirurgicaux - Clips intracrâniens pour anévrisme à autofermeture (ISO
9713:2022)
Ta slovenski standard je istoveten z: EN ISO 9713:2022
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.

EN ISO 9713
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2022
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 9713:2009
English Version
Neurosurgical implants - Self-closing intracranial
aneurysm clips (ISO 9713:2022)
Implants neurochirurgicaux - Clips intracrâniens pour Neurochirurgische Implantate - Selbstschließende
anévrisme à autofermeture (ISO 9713:2022) intrakranielle Aneurysmen-Clips (ISO 9713:2022)
This European Standard was approved by CEN on 12 December 2021.

CEN 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
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 member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies 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, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9713:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 9713:2022) has been prepared by Technical Committee ISO/TC 150 "Implants
for surgery" in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the
secretariat of which is held by DIN.
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 July 2022, and conflicting national standards shall be
withdrawn at the latest by July 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9713:2009.
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 website.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 9713:2022 has been approved by CEN as EN ISO 9713:2022 without any modification.

INTERNATIONAL ISO
STANDARD 9713
Third edition
2022-01
Neurosurgical implants — Self-closing
intracranial aneurysm clips
Implants neurochirurgicaux — Clips intracrâniens pour anévrisme à
autofermeture
Reference number
ISO 9713:2022(E)
ISO 9713:2022(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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 9713:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description of aneurysm clips . 2
4.1 Mechanism of action . 2
4.2 Geometry . 2
4.3 Blade closing surface . 2
5 Indication of dimensions . 3
6 Materials . 3
7 MRI safety assessment . 5
8 Design requirements .5
8.1 Closing force. 5
8.1.1 Measurement of actual closing force of clips . 5
8.1.2 Tolerance on nominal closing force . 6
8.1.3 Reduction of closing force . 6
8.2 V erification of blade surface . 6
8.3 A ssessment of maximum blade opening . 6
9 Supplying condition and sterilization . 6
10 Packaging. 6
11 Information supplied by the manufacturer . 7
11.1 General . 7
11.2 Implant processing by user . 7
11.3 Label . 7
11.4 Instructions for use . 7
11.5 Information for the patient . 7
11.5.1 General . 7
11.5.2 Patient record label . 8
11.5.3 Patient card . 8
Bibliography . 9
iii
ISO 9713:2022(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, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 285, Non-active
surgical implants, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 9713:2002), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— the terms and definitions in Clause 3 have been revised to more accurately define the information
contained within the document;
— the MRI safety assessment in Clause 7 has been revised so as to better align with the recommendations
provided in the most recent MRI related ASTM standards;
— the closing force assessments in Clause 8 has been revised to better clarify the procedures;
— the sterilization and packaging clauses (Clauses 9 and 10) have been revised to align with ISO 14630
and to reduce the likelihood of future conflicts.
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.
iv
ISO 9713:2022(E)
Introduction
This document is intended to help to ensure that appropriate and comparable information is supplied
for each clip to facilitate the choice of the correct clip by the surgeon. The closing force of the clip is an
important factor in the selection process, and this document requires that the manufacturers determine
the actual closing force in a uniform manner and state this value on the labelling. The actuation of some
types of clip can result in a reduction of the closing force and should be considered.
Magnetic fields of considerable strength [e.g. 1,5 (tesla) or more] are used in medicine with increasing
frequency as part of diagnostic techniques such as magnetic resonance imaging (MRI). Exposure to
electr
...