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SIST EN ISO 7197:2009
01-julij-2009
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SIST EN ISO 7197:2006
SIST EN ISO 7197:2006/AC:2008
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Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO
7197:2006, including Cor 1:2007)
Neurochirurgische Implantate - Sterile Hydrozephalus-Shunts zum Einmalgebrauch und
deren Bestandteile (ISO 7197:2006, einschließlich Cor 1:2007)
Implants neurochirurgicaux - Systèmes de dérivation et composants stériles, non
réutilisables, pour hydrocéphalie (ISO 7197:2006, Cor 1:2007 inclus)
Ta slovenski standard je istoveten z: EN ISO 7197:2009
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 7197:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7197:2009
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SIST EN ISO 7197:2009
EUROPEAN STANDARD
EN ISO 7197
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 7197:2006
English Version
Neurosurgical implants - Sterile, single-use hydrocephalus
shunts and components (ISO 7197:2006, including Cor 1:2007)
Implants neurochirurgicaux - Systèmes de dérivation et Neurochirurgische Implantate - Sterile Hydrozephalus-
composants stériles, non réutilisables, pour hydrocéphalie Shunts zum Einmalgebrauch und deren Bestandteile (ISO
(ISO 7197:2006, Cor 1:2007 inclus) 7197:2006, einschließlich Cor 1:2007)
This European Standard was approved by CEN on 19 April 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7197:2009: E
worldwide for CEN national Members.
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SIST EN ISO 7197:2009
EN ISO 7197:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 7197:2009
EN ISO 7197:2009 (E)
Foreword
The text of ISO 7197:2006, including Cor 1:2007 has been prepared by Technical Committee ISO/TC 150
“Implants for surgery” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 7197:2009 by 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 November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7197:2006.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 7197:2006, including Cor 1:2007 has been approved by CEN as a EN ISO 7197:2009 without
any modification.
3
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SIST EN ISO 7197:2009
EN ISO 7197:2009 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
All 1, 2, 3, 4, 5 Part of ER 1 relating to the risk
of use error is not covered by
current Standard.
4.2 2
4.3 7.1, 7.2 Part of ER 7.1 relating to
biophysical and modelling
research is not covered by this
European Standard.
4.4 7.5
4.5 3, 4, 13.6.d)
4.6 3, 4, 9.1
4.7 2, 13.6.d), 13.6.e)
4.8 4, 9.2, 12.7.1
4.9 12.7.1
4.10 9.1, 9.2
4.11 12.7.1
5.1.1 2, 4
5.1.2 4
5.1.3 4, 9.2
5.2 9.1, 12.7.1
6 13.1 ER 13.1 is covered via EN ISO
14630.
7 5, 7.2
4
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SIST EN ISO 7197:2009
EN ISO 7197:2009 (E)
8.1 13 The part of ER 13.3.a) relating to
the information on the authorized
representative is not addressed
by this European Standard.
8.2 13.6 The ER 13.3 f is only partly
addressed in this European
Standard: safety issue of single
use.
The part of ER 13.6.h) relating to
single use is not addressed in
this European Standard.
ER 13.6 q is not addressed in
this European Standard.
8.3 13.6.e)
6.a ER 6.a) is not addressed by this
European Standard.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
5
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SIST EN ISO 7197:2009
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SIST EN ISO 7197:2009
INTERNATIONAL ISO
STANDARD 7197
Third edition
2006-06-01
Neurosurgical implants — Sterile,
single-use hydrocephalus shunts and
components
Implants neurochirurgicaux — Systèmes de dérivation et composants
stériles, non réutilisables, pour hydrocéphalie
Reference number
ISO 7197:2006(E)
©
ISO 2006
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SIST EN ISO 7197:2009
ISO 7197:2006(E)
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ii © ISO 2006 – All rights reserved
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SIST EN ISO 7197:2009
ISO 7197:2006(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 7197:1997) which has been technically revised.
© ISO 2006 – All rights reserved iii
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SIST EN ISO 7197:2009
ISO 7197:2006(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.
Although the technical and phenomenological performance of the devices is significantly different, no design
has scientifically been proven to be superior. Due to the important technical differences, specific testing
procedures are necessary to investigate the performance of the different valves.
iv © ISO 2006 – All rights reserved
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SIST EN ISO 7197:2009
INTERNATIONAL STANDARD ISO 7197:2006(E)
Neurosurgical implants — Sterile, single-use hydrocephalus
shunts and components
1 Scope
This International Standard specifies safety and performance requirements for sterile, single-use non-active
hydrocephalus shunts and components. This includes the components used in
...