kSIST FprEN ISO 7197:2024

Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO/FDIS 7197:2024)

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/FDIS 7197:2024)

Dieses Dokument legt Anforderungen an die Leistung steriler nicht aktiver Hydrozephalus-Shunts zum Einmalgebrauch fest. Dazu gehören nicht nur das Ventil, sondern auch zusätzliche Bestandteile, wie z. B. Schläuche und Vorratsbehälter.
Dieses Dokument gibt keine Empfehlungen darüber, welcher Ventiltyp am geeignetsten für einen bestimmten Anwendungskontext ist.
Dieses Dokument legt die mechanischen und technischen Anforderungen für die Herstellung von Shunts und die durch den Hersteller bereitzustellenden technischen Informationen zum Ventil fest.
Dieses Dokument ist nicht anwendbar für aktive Implantate zur Behandlung des Hydrozephalus.

Implants neurochirurgicaux - Systèmes de dérivation stériles, non réutilisables, pour hydrocéphalie (ISO/FDIS 7197:2024)

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 (ISO/FDIS 7197:2024)

General Information

• Status: Not Published
• Public Enquiry End Date: 10-Sep-2023
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 09-May-2024
• Due Date: 27-Jun-2024
• Completion Date: 10-May-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: FprEN ISO 7197 - Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO/FDIS 7197:2024)

Relations

• Replaces: SIST EN ISO 7197:2009 - Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)
• Effective Date: 22-Sep-2021

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 7197:2023
01-september-2023
Nadomešča:
SIST EN ISO 7197:2009
Nevrokirurški vsadki (implantati) - Sterilni hidrocefalni stiki (kretnice) za enkratno
uporabo (ISO/DIS 7197:2023)
Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO/DIS 7197:2023)
Neurochirurgische Implantate - Sterile Hydrozephalus-Shunts zum Einmalgebrauch und
deren Bestandteile (ISO/DIS 7197:2023)
Implants neurochirurgicaux - Systèmes de dérivation stériles, non réutilisables, pour
hydrocéphalie (ISO/DIS 7197:2023)
Ta slovenski standard je istoveten z: prEN ISO 7197
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 7197:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 7197:2023

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oSIST prEN ISO 7197:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7197
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-06-12 2023-09-04
Neurosurgical implants — Sterile, single-use
hydrocephalus shunts
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 7197:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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oSIST prEN ISO 7197:2023

DRAFT INTERNATIONAL STANDARD
ISO/DIS 7197
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:

Neurosurgical implants — Sterile, single-use
hydrocephalus shunts
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 7197:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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oSIST prEN ISO 7197:2023
ISO/DIS 7197:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions .
...