EN ISO 7197:2024

SLOVENSKI STANDARD
01-januar-2025
Nadomešča:
SIST EN ISO 7197:2009
Nevrokirurški vsadki (implantati) - Sterilni hidrocefalni stiki (kretnice) za enkratno
uporabo (ISO 7197:2024)
Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO 7197:2024)
Neurochirurgische Implantate - Sterile Hydrozephalus-Shunts zum Einmalgebrauch und
deren Bestandteile (ISO 7197:2024)
Implants neurochirurgicaux - Systèmes de dérivation stériles, non réutilisables, pour
hydrocéphalie (ISO 7197:2024)
Ta slovenski standard je istoveten z: EN ISO 7197:2024
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 7197
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 7197:2009
English Version
Neurosurgical implants - Sterile, single-use hydrocephalus
shunts (ISO 7197:2024)
Implants neurochirurgicaux - Systèmes de dérivation Neurochirurgische Implantate - Sterile Hydrozephalus-
stériles, non réutilisables, pour hydrocéphalie (ISO Shunts zum Einmalgebrauch und deren Bestandteile
7197:2024) (ISO 7197:2024)
This European Standard was approved by CEN on 28 July 2024.

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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7197:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 4

European foreword
This document (EN ISO 7197:2024) 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 May 2025, and conflicting national standards shall be
withdrawn at the latest by May 2025.
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 7197:2009.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 7197:2024 has been approved by CEN as EN ISO 7197:2024 without any modification.

Annex ZA
(informative)
Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European Standard has been prepared under a Commission’s standardization request “M/575” to
provide one voluntary means of conforming to the General Safety and Performance Requirements of
Regulation (EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745).
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of
Regulation (EU) 2017/745 [OJ L 117] and to system or process requirements including those
relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Clause(s) / sub-
Performance
clause(s)
Requirements of Remarks / Notes
Regulation (EU)
of this EN
2017/745
10.1 (f) 4.9, 4.11, 5.1.2 10.1 (f) is covered with respect to:
dynamic breaking strength by 4.9.
bursting pressure by 4.11.
long term stability by 5.1.2 which specifies a test
method and performance requirement for
the valves.
10.1 (h) 4.2, 4.6 10.1 (h) is covered with respect to:
radiopacity by 4.2.
pressure-flow characteristics by 4.6.
10.2 7 10.2 is covered with respect to the material of
the packaging being non-fibrous and lint-free by
Clause 7.
11.1 (c) 4.4 11.1 (c) is covered with respected to resistance
to leakage by 4.4.
14.2 (b) 4.10 14.2 (b) is covered with respect to magnetically
induced forces, moments, and heating and with
respect to image artefacts produced by the
shunt under worst-case MR scanning conditions
by 4.10.
23.1 (b) 6 23.1 (b) is covered with respect to marking
indicating the intended direction of flow by
Clause 6.
23.4 (e) 8.2 g), h), i), j) and k) 23.4 (e) is covered with respect to the flow
characteristics of the valve by 8.2 g), h), i), j) and
k).
23.4 (i) 8.2 a), b) 23.4 (i) is covered with respect to:
instructions for assembly of the shunt system by
8.2 a).
instructions for the pre and postoperative
testing of the functionality of the shunt by
8.2 b).
23.4 (k) 8.2 b), c), e) and l) 23.4 (k) is covered with respect to:
instructions for the pre and postoperative
testing of the functionality of the shunt by
8.2 b)
warning notices concerning the maximum
General Safety and
Clause(s) / sub-
Performance
clause(s)
Requirements of Remarks / Notes
Regulation (EU)
of this EN
2017/745
positive and negative pressure that can be
applied to the system without impairing its
performance by 8.2 c).
an indication regarding how the flow direction
of the device can be determined by 8.2 e).
an instruction if and how the shunt shall be
tested and/or readjusted after MR
examination by 8.2 l).
23.4 (s) 8.3 23.4 (s) is covered with respect to warning
against the hazards of exposure to magnetic
fields by 8.3.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding European
Clause 2 Standard Edition
Standard Edition
ISO/TR 14283 ISO/TR Implants for surgery — Essential -
14283:2018 principles of safety and
performance
ISO 14630:2024 ISO 14630:2024 Non-active surgical implants — EN ISO 14630:2024
General requirements
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
International
Standard
ISO 7197
Fourth edition
Neurosurgical implants — Sterile,
2024-07
single-use hydrocephalus shunts
Implants neurochirurgicaux — Systèmes de dérivation stériles,
non réutilisables, pour hydrocéphalie
Reference number
ISO 7197:2024(en) © ISO 2024
ISO 7197:2024(en)
© ISO 2024
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Published in Switzerland
ii
ISO 7197:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements for shunts . 2
4.1 General .
...