Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)

ISO 7197:2006 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.
For manufacturing, ISO 7197:2006 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 ISO 7197:2006 for the surgeon and the patient is to understand the information given by the manufacturer and to obtain standardized information about the performance of a well working product with new design characteristics. The benefit for the manufacturer is to define the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture.

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)

L'ISO 7197:2006 spécifie les exigences de sécurité et de performance requises pour les systèmes de dérivation et composants stériles, non réutilisables, pour l'hydrocéphalie, notamment les valves, les tubes et les réservoirs.
L'ISO 7197:2006 définit les exigences mécaniques et techniques relatives à la fabrication. Elle définit les informations techniques concernant la valve qui doivent être fournies par le fabricant. Compte tenu du fait que les différents types de valves fonctionnent selon des principes différents, des caractéristiques spécifiques sont définies pour chaque groupe selon les indications du fabricant.
Pour le chirurgien comme pour le patient, l'ISO 7197:2006 a pour avantage de permettre de mieux comprendre les indications données par le fabricant et d'avoir une information normalisée concernant le fonctionnement d'un produit en bon état de marche, doté de nouvelles caractéristiques de conception. Pour le fabricant, l'avantage est de définir les exigences importantes applicables aux systèmes de dérivation qui seront utilisées comme base d'investigation dans les phases de développement ainsi que pour les contrôles et les essais en cours de fabrication.

Nevrokirurški vsadki (implantati) - Sterilni hidrocefalni stiki (kretnice) za enkratno uporabo in komponente (ISO 7197:2006, vključno s popravkom 1:2007)

General Information

Status
Published
Publication Date
12-May-2009
Withdrawal Date
20-Mar-2010
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
13-May-2009
Completion Date
13-May-2009

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7197:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 7197:2006
SIST EN ISO 7197:2006/AC:2008
1HYURNLUXUãNLYVDGNL LPSODQWDWL 6WHULOQLKLGURFHIDOQLVWLNL NUHWQLFH ]DHQNUDWQR
XSRUDERLQNRPSRQHQWH ,62YNOMXþQRVSRSUDYNRP
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,
...

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