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)

General Information

Status
Published
Public Enquiry End Date
24-Mar-2021
Publication Date
11-May-2022
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Apr-2022
Due Date
06-Jun-2022
Completion Date
12-May-2022

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SLOVENSKI STANDARD
SIST EN ISO 9713:2022
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
SIST EN ISO 9713:2022 en,fr,de

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

---------------------- Page: 1 ----------------------
SIST EN ISO 9713:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 9713:2022
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 9713:2022
EN ISO 9713:2022 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 9713:2022
EN ISO 9713:2022 (E)
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.

---------------------- Page: 5 ----------------------
SIST EN ISO 9713:2022
---------------------- Page: 6 ----------------------
SIST EN ISO 9713:2022
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 2022
---------------------- Page: 7 ----------------------
SIST EN ISO 9713:2022
ISO 9713:2022(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
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 9713:2022
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 2022 – All rights reserved
---------------------- Page: 9 ----------------------
SIST EN ISO 9713:2022
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.
© ISO 2022 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 9713:2022
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
...

SLOVENSKI STANDARD
oSIST prEN ISO 9713:2021
01-marec-2021
Nevrokirurški vsadki (implantati) - Samozapiralne sponke za uporabo pri
intrakranialnih anevrizmah (ISO/DIS 9713:2021)

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO/DIS 9713:2021)

Neurochirurgische Implantate - Selbstschließende intrakranielle Aneurysmen-Clips
(ISO/DIS 9713:2021)
Implants neurochirurgicaux - Clips intracrâniens pour anévrisme à autofermeture
(ISO/DIS 9713:2021)
Ta slovenski standard je istoveten z: prEN ISO 9713
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 9713:2021 en,fr,de

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

---------------------- Page: 1 ----------------------
oSIST prEN ISO 9713:2021
---------------------- Page: 2 ----------------------
oSIST prEN ISO 9713:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 9713
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:
2021-02-03 2021-04-28
Neurosurgical implants — Self-closing intracranial
aneurysm clips
Implants neurochirurgicaux — Clips intracrâniens pour anévrisme à autofermeture
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 9713:2021(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 2021
---------------------- Page: 3 ----------------------
oSIST prEN ISO 9713:2021
ISO/DIS 9713:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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 2021 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 9713:2021
ISO/DIS 9713:2021(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.................................................................................................................................................................................... 6

8 Design Requirements ...................................................................................................................................................................................... 6

8.1 Closing force .............................................................................................................................................................................................. 6

8.1.1 Measurement of actual closing force of clips........................................................................................... 6

8.1.2 Tolerance on nominal closing force ................................................................................................................. 7

8.1.3 Reduction of closing force ........................................................................................................................................ 7

8.2 Verification of blade surface ........................................................................................................................................................ 7

8.3 Assessment of maximum blade opening .......................................................................................................................... 7

9 Supplying condition and sterilization ............................................................................................................................................ 7

10 Packaging ..................................................................................................................................................................................................................... 7

11 Information supplied by the manufacturer ............................................................................................................................. 7

11.1 General ........................................................................................................................................................................................................... 7

11.2 Implant processing by user .......................................................................................................................................................... 8

11.3 Label ................................................................................................................................................................................................................. 8

11.4 Instructions for use ............................................................................................................................................................................. 8

11.5 Information for the patient .......................................................................................................................................................... 8

11.5.1 General...................................................................................................................................................................................... 8

11.5.2 Patient record label ....................................................................................................................................................... 8

11.5.3 Patient card .................. .................................................... ..................................................................................................... 8

Bibliography .............................................................................................................................................................................................................................10

© ISO 2021 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 9713:2021
ISO/DIS 9713:2021(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 on 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 the following

URL: www .iso .org/ iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 150, Implants for Surgery.

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:

— terms and definitions have been revised to more accurately define the information contained within

the document;

— Clause 7 "MRI safety" has been revised as to better align with the recommendations provided in the

most recent ASTM standard related to MRI;

— in Clause 8 the closing force assessment was edited to better clarify the procedures;

— Clause 9 "Supplying condition and sterilization" and Clause 10 "Packaging" have been revised as to

align with ISO 14630 and to reduce the likelihood of future conflicts between the two documents.

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 2021 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 9713:2021
ISO/DIS 9713:2021(E)
Introduction

One of the main intentions of this document is 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

electromagnetic radiation may pose a hazard to patients who have intracranial aneurysm clips. Clips

with magnetic properties (dia-, para-, antiferro-, ferro- and/or ferrimagnetic) become magnetized

when subjected to a magnetic field and under this condition are liable to directing forces. These forces

may result in the clip being removed from the aneurysm that it was intended to occlude and even being

moved through the tissues. Because of the very high field strengths, even materials normally regarded

as non-magnetic may exhibit some response to the magnetic field, such as minimal deflection or rotation.

It is therefore essential that aneurysm clips have weakly or non-magnetic properties. Compounds of

certain non-magnetic elements may, when processed, have strong magnetic properties. The opposite

also occurs. The work done at manufacture may have an additional effect. However, material normally

regarded as non-magnetic may exhibit some response when subjected to MRI levels of field strength. A

secondary effect is that the presence of a metallic clip may interfere with the MRI process, resulting in

deterioration of the quality of the scanning image.
© ISO 2021 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 9713:2021
---------------------- Page: 8 ----------------------
oSIST prEN ISO 9713:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 9713:2021(E)
Neurosurgical implants — Self-closing intracranial
aneurysm clips
1 Scope
This document describes characteristics of self-closing aneu
...

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