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 - Systèmes 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 betw
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