SIST EN ISO 15798:2022
(Main)Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices 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 intraocular tissues and to manipulate tissues during surgery.
This document 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 15798:2022)
Dieses Dokument ist anwendbar für ophthalmische viskoelastische Substanzen (OVD, en: ophthalmic viscosurgical devices), eine Klasse chirurgischer invasiver Medizinprodukte mit viskosen und/oder viskoelastischen Eigenschaften, die für den Einsatz bei chirurgischen Eingriffen im Vorderabschnitt des menschlichen Auges bestimmt sind. OVDs dienen dazu, Raum zu schaffen und zu erhalten, intraokulares Gewebe zu schützen und Gewebe während des chirurgischen Eingriffs zu manipulieren.
Dieses Dokument legt Anforderungen bezüglich der Sicherheit für die beabsichtigte Leistung, Konstruktionsmerkmale, an vorklinische und klinische Bewertungen, Sterilisation, Produktverpackung, Produktkennzeichnung und die Bereitstellung von Informationen durch den Hersteller dieser Produkte fest.
Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO 15798:2022)
Le présent document s'applique aux dispositifs ophtalmiques viscoélastiques (OVD), une catégorie de dispositifs médicaux invasifs de type chirurgical 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.
Le présent document spécifie les exigences en matière de sécurité pour l'utilisation prévue, les caractéristiques de conception, l'évaluation préclinique et clinique, la stérilisation, l'emballage du produit, l'étiquetage du produit et les informations fournies par le fabricant de ces dispositifs.
Očesni vsadki (implantati) - Očesni kirurški pripomočki (ISO 15798:2022)
Ta dokument se uporablja za očesne kirurške pripomočke (OVD) (razred kirurško invazivnih medicinskih pripomočkov z viskoznimi in/ali viskoznoelastičnimi lastnostmi), ki so namenjeni za uporabo med operacijo v frontalnem segmentu človeškega očesa. Očesni kirurški pripomočki so namenjeni ustvarjanju in vzdrževanju prostora, zaščiti tkiv znotraj očesa in manipulaciji tkiva med operacijo. Ta dokument določa zahteve glede varnosti za predvidene lastnosti, atribute načrtovanja, predklinično in klinično vrednotenje, sterilizacijo, pakiranje izdelkov, označevanje izdelkov in informacije, ki jih dobavlja proizvajalec teh pripomočkov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2022
Nadomešča:
SIST EN ISO 15798:2013
SIST EN ISO 15798:2013/A1:2017
Očesni vsadki (implantati) - Očesni kirurški pripomočki (ISO 15798:2022)
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
Ophthalmische Implantate - Viskoelastische Substanzen (ISO 15798:2022)
Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO 15798:2022)
Ta slovenski standard je istoveten z: EN ISO 15798:2022
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 15798
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2022
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 15798:2013, EN ISO
15798:2013/A1:2017
English Version
Ophthalmic implants - Ophthalmic viscosurgical devices
(ISO 15798:2022)
Implants ophtalmiques - Dispositifs ophtalmiques Ophthalmische Implantate - Viskoelastische
viscoélastiques (ISO 15798:2022) Substanzen (ISO 15798:2022)
This European Standard was approved by CEN on 17 January 2022.
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-CENELEC 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-CENELEC 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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15798:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 15798:2022) 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 2022, and conflicting national standards shall
be withdrawn at the latest by August 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15798:2013.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 15798:2022 has been approved by CEN as EN ISO 15798:2022 without any modification.
INTERNATIONAL ISO
STANDARD 15798
Fourth edition
2022-01
Ophthalmic implants — Ophthalmic
viscosurgical devices
Implants ophtalmiques — Dispositifs ophtalmiques viscoélastiques
Reference number
ISO 15798:2022(E)
ISO 15798:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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Published in Switzerland
ii
ISO 15798:2022(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance .3
5 Design attributes .4
5.1 General . 4
5.2 Characterization of the components . 4
5.3 Characterization of the finished product. 4
5.3.1 General . 4
5.3.2 Absolute complex viscosity . 5
5.3.3 Chemical and biological contaminants . 5
5.3.4 Concentration . 5
5.3.5 Elasticity . 5
5.3.6 Molecular mass distribution . 5
5.3.7 Osmolality . 5
5.3.8 Particulates . 6
5.3.9 pH . 6
5.3.10 Refractive index . 6
5.3.11 Shear viscosity . 6
5.3.12 Spectral transmittance . . 6
5.4 Usability . 7
6 Design evaluation . 7
6.1 General . 7
6.2 Evaluation of biological safety . 7
6.2.1 General . 7
6.2.2 Bacterial endotoxins test . 8
6.2.3 Clearance of residual OVD from the anterior chamber . 8
6.2.4 Degradation and toxicokinetics . 8
6.2.5 Evaluation of inflammation and intraocular pressure . 8
6.3 Clinical evaluation . 8
6.3.1 General . 8
6.3.2 Clinical investigation design . 9
6.3.3 Corneal endothelial cell density . 9
6.3.4 Postoperative inflammation . 9
6.3.5 Post-operative intraocular pressure change . 10
6.3.6 Adverse events . 10
7 Sterilization .10
8 Product stability .11
9 Integrity and performance of the delivery system .11
10 Packaging.11
10.1 Protection from damage during storage and transport. 11
10.2 Maintenance of sterility in transit . 11
11 Information to be supplied by the manufacturer .11
Annex A (normative) Intraocular implantation test .13
Annex B (informative) Patient numbers for clinical investigation of intraocular pressure .16
Annex C (informative) Analyses of OVD clinical data .17
Bibliography .19
iii
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