EN ISO 15798:2010

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)

ISO 15798:2010 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery.
ISO 15798:2010 specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.

Ophthalmische Implantate - Viskoelastische Substanzen (ISO 15798:2010)

Diese Internationale Norm ist anwendbar auf ophthalmische viskoelastische Substanzen, einer Klasse nichtaktiver
chirurgischer Implantate mit viskosen und/oder viskoelastischen Eigenschaften, die für den Einsatz bei
chirurgischen Eingriffen im Vorderabschnitt des menschlichen Auges bestimmt sind. Viskoelastische Substanzen
wurden zur Schaffung und Aufrechterhaltung von Raum, zum Schutz der Intraokulargewebe und zur
Manipulation von Gewebe während des chirurgischen Eingriffs entwickelt.
Mit Bezug auf die Sicherheit legt diese Internationale Norm Anforderungen für die beabsichtigte Funktion,
Konstruktionsmerkmale, vorklinische und klinische Auswertungen, Sterilisation, Verpackung, Kennzeichnung
und die Bereitstellung von Informationen durch den Hersteller dieser Produkte sowie für Prüfverfahren fest.

Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO 15798:2010)

L'ISO 15798:2010 s'applique aux dispositifs ophtalmiques viscoélastiques (OVD), catégorie d'implants chirurgicaux non actifs présentant des propriétés de viscosité et/ou de viscoélasticité, destinés à une utilisation en chirurgie dans le segment antérieur de l'œil humain. Les OVD sont conçus pour créer et maintenir de l'espace, pour protéger les tissus intraoculaires et manipuler les tissus au cours d'interventions chirurgicales.
L'ISO 15798:2010 définit les exigences, en matière de sécurité pour l'utilisation prévue, de conception, d'évaluation préclinique et clinique, de stérilisation, de conditionnement du produit, d'étiquetage du produit et d'informations fournies par le fabricant sur les dispositifs.

Očesni vsadki (implantati) - Očesni kirurški pripomočki (ISO 15798:2010)

Ta mednarodni standard velja za očesne kirurške pripomočke (OVD), razred neaktivnih kirurških vsadkov z viskoznimi in/ali viskoznoelastičnimi lastnostmi, ki so namenjeni uporabi med operacijo prednjega dela človeškega očesa. Očesni kirurški pripomočki so zasnovani tako, da ustvarijo in vzdržujejo prostor za zaščito znotrajočesnih tkiv in premikanje tkiv med operacijo. Ta mednarodni standard določa zahteve v zvezi z varnostjo za predvideno delovanje, lastnosti modela, predklinično in klinično ovrednotenje, sterilizacijo, pakiranje proizvodov, uporabo nalepk na proizvodih in informacije, ki jih priskrbi proizvajalec teh pripomočkov.

General Information

• Status: Withdrawn
• Publication Date: 31-Jan-2010
• Withdrawal Date: 17-Sep-2013
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 18-Sep-2013
• Completion Date: 18-Sep-2013
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 15798:2010 - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)

Relations

• Replaces: EN ISO 15798:2001/AC:2005 - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001)
• Effective Date: 04-Dec-2010
• Replaces: EN ISO 15798:2001 - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 15798:2013 - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15798:2010
01-junij-2010
1DGRPHãþD
SIST EN ISO 15798:2002
SIST EN ISO 15798:2002/AC:2005
2þHVQLYVDGNLLPSODQWDWL2þHVQLNLUXUãNLSULSRPRþNL,62
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)
Ophthalmische Implantate - Viskoelastische Substanzen (ISO 15798:2010)
Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO 15798:2010)
Ta slovenski standard je istoveten z: EN ISO 15798:2010
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 15798:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15798:2010

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SIST EN ISO 15798:2010


EUROPEAN STANDARD
EN ISO 15798

NORME EUROPÉENNE

EUROPÄISCHE NORM
February 2010
ICS 11.040.70 Supersedes EN ISO 15798:2001
English Version
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO
15798:2010)
Implants ophtalmiques - Dispositifs ophtalmiques Ophthalmische Implantate - Viskoelastische Substanzen
viscoélastiques (ISO 15798:2010) (ISO 15798:2010)
This European Standard was approved by CEN on 30 January 2010.

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, Croatia, 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
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15798:2010: E
worldwide for CEN national Members.

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SIST EN ISO 15798:2010
EN ISO 15798:2010 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

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SIST EN ISO 15798:2010
EN ISO 15798:2010 (E)
Foreword
This document (EN ISO 15798:2010) has been prepared by Technical Committee ISO/TC 172 "Optics and
photonics" in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” 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 August 2010, and conflicting national standards shall be withdrawn at
the latest by August 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 15798:2001.
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.
For relationship with EU 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, Croatia, 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 15798:2010 has been approved by CEN as a EN ISO 15798:2010 without any modification.
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SIST EN ISO 15798:2010
EN ISO 15798:2010 (E)
Annex ZA
...