SIST EN ISO 7197:2006
(Main)Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006)
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006)
This International Standard specifies requirements for sterile, single-use hydrocephalus shunts and components. This International Standard is applicable to, but is not limited to: a) complete sterile, single-use hydrocephalus shunts of the one-piece type; or b) complete sterile, single-use hydrocephalus shunts of the multipiece type, supplied either assembled by the manufacturer or in kit form for assembly by the physician; or c) sterile, single-use shunt components which (individually or in combination) compromise shunt assemblies, for example: valves, valved catheters...
Neurochirurgische Implantate - Sterile Hydrozephalus-Shunts zum Einmalgebrauch und deren Bestandteile (ISO 7197:2006)
Diese Internationale Norm legt Anforderungen an Sicherheit und Funktion steriler nicht aktiver Hydrozephalus-Shunts zum Einmalgebrauch und deren Bestandteile fest. Dabei sind die in diesen Shunts verwendeten Bestandteile wie Ventile, Schläuche und Vorratsbehälter einbezogen.
Diese Internationale Norm gibt keine Empfehlung hinsichtlich der Überlegenheit eines bestimmten Ventiltyps.
Für die Herstellung legt sie die mechanischen und technischen Anforderungen fest, die erfüllt werden sollten. Die Internationale Norm legt die technischen Informationen fest, die durch den Hersteller zu liefern sind. Im Hinblick auf die unterschiedlichen Prinzipien der Ventiltypen sind für jede Gruppe besondere Merkmale festgelegt, die durch den Hersteller angegeben werden müssen.
Der Nutzen dieser Internationalen Norm für den Chirurgen und den Patienten ist, dass die vom Hersteller angegebenen Informationen verstanden werden, und dass genormte Angaben über die Leistung eines gut funktionierenden Produkts mit neuen Konstruktionsmerkmalen zur Verfügung stehen. Der Nutzen für den Hersteller ist die Festlegung der grundlegenden wichtigen Anforderungen an Shunts als Grundlage für in Entwicklung stehende Forschungen wie auch für die Qualitätskontrolle im Laufe der Herstellung.
Diese Internationale Norm gilt nicht für aktive Implantate zur Behandlung des Hydrozephalus.
Implants neurochirurgicaux - Systemes de dérivation et composants stériles, non réutilisables, pour hydrocéphalie (ISO 7197:2006)
Nevrokirurški vsadki (implantati) - Sterilni hidrocefalni stiki (kretnice) za enkratno uporabo in komponente (ISO 7197:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7197:2006
01-julij-2006
Nevrokirurški vsadki (implantati) - Sterilni hidrocefalni stiki (kretnice) za enkratno
uporabo in komponente (ISO 7197:2006)
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO
7197:2006)
Neurochirurgische Implantate - Sterile Hydrozephalus-Shunts zum Einmalgebrauch und
deren Bestandteile (ISO 7197:2006)
Implants neurochirurgicaux - Systemes de dérivation et composants stériles, non
réutilisables, pour hydrocéphalie (ISO 7197:2006)
Ta slovenski standard je istoveten z: EN ISO 7197:2006
ICS:
11.040.40
SIST EN ISO 7197:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 7197
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2006
ICS 11.040.40
English Version
Neurosurgical implants - Sterile, single-use hydrocephalus
shunts and components (ISO 7197:2006)
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) 7197:2006)
This European Standard was approved by CEN on 19 May 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7197:2006: E
worldwide for CEN national Members.
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EN ISO 7197:2006 (E)
Foreword
This document (EN ISO 7197:2006) 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 NEN.
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 December 2006, and conflicting national
standards shall be withdrawn at the latest by December 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 EU Directive(s).
For relationship with EU Directive(s), 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, 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.
Endorsement notice
The text of ISO 7197:2006 has been approved by CEN as EN ISO 7197:2006 without any
modifications.
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EN ISO 7197:2006 (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 to provide a means of conforming to Essential Requirements of the New Approach
Directive 93/42/EEC of 14 June 1993 concerning 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.1 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.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/Sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this European Standard EU Directive 93/42/EEC
All 1, 2, 3, 4, 5
4.2 2
4.3 7.1, 7.2
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
7 5, 7.2
8.1 13
8.2 13.6
8.3 13.6.e)
WARNING: Other requirements and other EU Directives may be applicable to the products falling
within the scope of this standard.
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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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ISO 7197:2006(E)
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ii © ISO 2006 – All rights reserved
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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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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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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 shunts, like valves, tubes and
reservoirs.
This International Standard gives no recommendation concerning the superiority of a certain type of valve.
For manufacturing, it defines the mechanical and technical requirements. This International Standard defines
the technical information of the valve, to be given by the manufacturer. In respect to the different principles of
the valve types, specific characteristics are defined for each group as declared by the manufacturer.
The benefit of this International Standard for the surgeon and the patient is to understand the in
...
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