EN ISO 15798:2010
(Main)Ophthalmic implants - Ophthalmic viscosurgical devices (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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2010
1DGRPHãþD
SIST EN ISO 15798:2002
SIST EN ISO 15798:2002/AC:2005
2þHVQLYVDGNL LPSODQWDWL 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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
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.
Annex ZA
(informative)
Relationship between this International Standard and the Essential Requirements of
EU Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European Commission
[and the European Free Trade Association] to provide a means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
International Standard given in Table ZA.1 confers, within the limits of the scope of this International Standard,
a presumption of conformity with the corresponding Essential Requirements of that Directive and associated
EFTA regulations.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of Essential Requirements Qualifying remarks/Notes
this International Standard (ERs) of Directive 93/42/EEC
4 Reference to ISO 14630 for general requirements
1, 2, 3
of non-active implants
1, 2, 3, 7.1, 7.2, 8.2, 9.2 Reference to ISO 14971 for risk assessment
Reference to ISO 22442-1, ISO 22442-2, ISO
22442-3 for material of animal origin
1, 2, 3, 7.1, 7.2, 7.5, 8.2 Reference to ISO 22442-1, ISO 22442-2, ISO
6.1, 6.2
22442-3 for material of animal origin
Reference to ISO 10993-1 for testing of biological
safety in general
Reference to ISO 10993-9, ISO 10993-16 for
toxicokinetics of degradation products
6.3 6, 6a, 7.3 Reference to ISO 14155 for clinical investigation
in general
1, 2, 7.2, 7.5, 7.6, Reference to ISO 17665-1 for sterilization by
8.1, 8.3, 8.4 moist heat
Reference to ISO 11137-1, ISO 11137-2, ISO
11137-3 for sterilization by radiation
Reference to ISO 13408-1 for aseptic processing
Reference to ISO 11135-1 for sterilization with
ethylene oxide
Table ZA.1 (continued)
Clause(s)/sub-clause(s) of Essential Requirements Qualifying remarks/Notes
this International Standard (ERs) of Directive 93/42/EEC
8 1, 3, 4, 5, 8.3
9 1, 2, 3, 4, 7.1, 9.1
1, 3, 4, 5, 8.3 Reference to ISO 11607-1 and ISO 14630 for
packaging requirements
2, 8.7, 13 Ophthalmic viscosurgical devices (OVD)
containing medicinal substances, or human blood
derivatives, have not been considered in the
standard, and at present no such products are
known Custom made OVD are not known
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 15798
Second edition
2010-02-01
Ophthalmic implants — Ophthalmic
viscosurgical devices
Implants ophtalmiques — Dispositifs ophtalmiques viscoélastiques
Reference number
ISO 15798:2010(E)
©
ISO 2010
ISO 15798:2010(E)
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ISO 15798:2010(E)
Contents Page
Foreword .iv
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Intended performance.4
5 Design attributes .4
5.1 General .4
5.2 Characterization of the components .4
5.3 Characterization of the finished product .4
6 Design evaluation.6
6.1 General .6
6.2 Evaluation of biological safety.7
6.3 Clinical evaluation .8
7 Sterilization .10
8 Product stability .10
9 Integrity and performance of the delivery system .10
10 Packaging.10
10.1 Protection from damage during storage and transport .10
10.2 Maintenance of sterility in transit .10
11 Information to be supplied by the manufacturer .11
Annex A (normative) Intraocular implantation test .12
Annex B (informative) Patient numbers for clinical investigation of intra-ocular pressure .15
Bibliography.16
ISO 15798:2010(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 15798 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 15798:2001) which has been technically
revised. It also includes the Technical Corrigendum IS
...
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