FprEN ISO 7197

SLOVENSKI STANDARD
oSIST prEN ISO 7197:2023
01-september-2023
Nadomešča:
SIST EN ISO 7197:2009
Nevrokirurški vsadki (implantati) - Sterilni hidrocefalni stiki (kretnice) za enkratno
uporabo (ISO/DIS 7197:2023)
Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO/DIS 7197:2023)
Neurochirurgische Implantate - Sterile Hydrozephalus-Shunts zum Einmalgebrauch und
deren Bestandteile (ISO/DIS 7197:2023)
Implants neurochirurgicaux - Systèmes de dérivation stériles, non réutilisables, pour
hydrocéphalie (ISO/DIS 7197:2023)
Ta slovenski standard je istoveten z: prEN ISO 7197
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 7197:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 7197:2023
oSIST prEN ISO 7197:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7197
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-06-12 2023-09-04
Neurosurgical implants — Sterile, single-use
hydrocephalus shunts
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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 7197:2023(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 2023

oSIST prEN ISO 7197:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7197
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:

Neurosurgical implants — Sterile, single-use
hydrocephalus shunts
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
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TECHNOLOGICAL, COMMERCIAL AND
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POTENTIAL TO BECOME STANDARDS TO
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WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 7197:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 7197:2023
ISO/DIS 7197:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements for shunts .3
4.1 General . 3
4.2 Radiopacity . 3
4.3 Biocompatibility . 3
4.4 Resistance to leakage . 3
4.5 Control of the implanted shunt . 3
4.6 Pressure‑flow characteristics of the valve, the components and the pre‑assembled
shunt . 3
4.7 Identification of shunts in vivo . . 4
4.8 Ability to withstand overpressure . 4
4.9 Dynamic breaking strength . 4
4.10 Behaviour under MR imaging conditions . 4
4.11 Bursting pressure . 4
5 Specific requirements for components . 5
5.1 Valves . 5
5.1.1 Reflux performance of shunts connecting the ventricle to the blood system . 5
5.1.2 Long term stability . 5
5.1.3 Influence of the changed posture of the patient on the valve performance . 5
5.2 Resistance of tubing and components . 5
6 Marking and labelling of shunts . 5
7 Packaging. 6
8 Information supplied by the manufacturer . 6
8.1 General . 6
8.2 Instructions for use . 6
8.3 Implant card . . 6
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .8
Bibliography .10
iii
oSIST prEN ISO 7197:2023
ISO/DIS 7197:2023(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
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.
ISO 7197 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 3,
Neurosurgical implants.
This third edition cancels and replaces the second edition (ISO 7197:2006) which has been technically
revised.
The main changes compared to the previous edition are as follows:
— complete revision of 4.1 “MRI compatibility”;
— additional clarifying edits regarding terminology and updated standard references.
iv
oSIST prEN ISO 7197:2023
ISO/DIS 7197:2023(E)
Introduction
A shunt is defined as an artificial connection of two compartments inside the body. For the treatment of
hydrocephalus, the ventriculo‑atrial shunt has been introduced initially to control the intraventricular
pressure in the brain of the patients. Today ventriculo‑peritoneal shunts are preferably implanted. In
special cases, a lumbo‑peritoneal shunt is implanted. Normally a hydrocephalus shunt includes a valve
which determines the resulting intraventricular pressure in the brain of the patients and influences the
flow rate through the shunt.
The following types of valve are currently commercially available.
a) Conventional differential-pressure valves (DP-valves) are designed as ball-in-cone valves,
membrane valves or silicone slit valves. They have one characteristic opening pressure. If the
difference pressure between inlet and outlet exceeds this opening pressure the device opens.
After opening, the different types of DP‑valve show a wide range of different flow characteristics.
Differences due to a changed posture of the patient have no intended impact on the function of the
devices.
b) Adjustable DP‑valves act like conventional DP‑valves. In contrast to non‑adjustable devices they
introduce the possibility of a non‑invasive readjustment of the opening characteristic after
implantation. They do not take into account changes due to a changed posture of the patient.
c) Gravitation valves or hydrostatic devices take into account the changed physics in a shunt due
to a changed posture of the patient. These devices aim to avoid an unphysiological negative
intraventricular pressure in the upright position of the patient, which might be the consequence
of the hydrostatic pressure in shunts with adjustable or not adjustable DP‑valves. There are three
different hydrostatic devices commercially available: flow‑reducing devices, valves with a so‑called
“anti‑siphon‑device” or “siphon‑control‑device” and gravity‑assisted devices.
d) Other adjustable valves, e.g.:
— gravitation valves: adjustable hydrostatic devices present in addition to the characteristics of
hydrostatic devices (group 4) with the possibility of a non‑invasive readjustment of the opening
performance of the device;
— adjustable anti‑siphon‑device valves;
— adjustable flow‑reducing valves.
Due to the important technical differences, specific testing procedures are necessary to investigate the
performance of the different valves.
v
oSIST prEN ISO 7197:2023
oSIST prEN ISO 7197:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 7197:2023(E)
Neurosurgical implants — Sterile, single-use
hydrocephalus shunts
1 Scope
This document specifies safety and performance requirements for sterile, single‑use non‑active
hydrocephalus shunts. This includes not only the valve, but
...