EN ISO 15798:2013
(Main)Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)
ISO 15798:2013 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 15798:2013 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 15798:2013)
Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO 15798:2013)
L'ISO 15798:2013 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'?il 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 15798:2013 spécifie 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 15798:2013)
Ta mednarodni standard se uporablja za očesne kirurške pripomočke (razred neaktivnih kirurških vsadkov 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 mednarodni standard 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-november-2013
1DGRPHãþD
SIST EN ISO 15798:2010
2þHVQLYVDGNL LPSODQWDWL 2þHVQLNLUXUãNLSULSRPRþNL ,62
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)
Ophthalmische Implantate - Viskoelastische Substanzen (ISO 15798:2013)
Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO 15798:2013)
Ta slovenski standard je istoveten z: EN ISO 15798:2013
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
September 2013
ICS 11.040.70 Supersedes EN ISO 15798:2010
English Version
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO
15798:2013)
Implants ophtalmiques - Dispositifs ophtalmiques Ophthalmische Implantate - Viskoelastische Substanzen
viscoélastiques (ISO 15798:2013) (ISO 15798:2013)
This European Standard was approved by CEN on 2 April 2013.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15798:2013: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
Foreword
This document (EN ISO 15798:2013) 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 March 2014, and conflicting national standards shall be withdrawn at
the latest by March 2014.
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 15798:2010.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15798:2013 has been approved by CEN as EN ISO 15798:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European 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
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of Essential Requirements (ERs) Qualifying remarks/Notes
this EN of Directive 93/42/EEC
5, 6.1, 6.2, 7 7.2 Reference to ISO 14971 for risk assessment.
Reference to ISO 22442-1, ISO 22442-2,
ISO 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.
Reference to ISO 17665-1 for sterilization by
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.
6.2 7.3
6.1, 6.2, 7 7.5 Reference to ISO 22442-1, ISO 22442-2,
ISO 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.
Reference to ISO 17665-1 for sterilization by
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.
Clause(s)/sub-clause(s) of Essential Requirements (ERs) Qualifying remarks/Notes
this EN of Directive 93/42/EEC
7 7.6 Reference to ISO 17665-1 for sterilization by
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.
7 8.1 Reference to ISO 17665-1 for sterilization by
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.
5, 6.1, 6.2 8.2 Reference to ISO 14971 for risk assessment.
Reference to ISO 22442-1, ISO 22442-2,
ISO 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.
7, 8, 10 8.3 Reference to ISO 17665-1 for sterilization by
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.
Reference to ISO 11607-1 and ISO 14630 for
packaging requirements.
7 8.4 Reference to ISO 17665-1 for sterilization by
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.
11 8.7
9 9.1
5 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.
Clause(s)/sub-clause(s) of Essential Requirements (ERs) Qualifying remarks/Notes
this EN of Directive 93/42/EEC
11 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
Third edition
2013-09-15
Ophthalmic implants — Ophthalmic
viscosurgical devices
Implants ophtalmiques — Dispositifs ophtalmiques viscoélastiques
Reference number
ISO 15798:2013(E)
©
ISO 2013
ISO 15798:2013(E)
© ISO 2013
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ISO 15798:2013(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
6 Design evaluation . 6
6.1 General . 6
6.2 Evaluation of biological safety . 6
6.3 Clinical evaluation . 7
7 Sterilization . 9
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 .10
Annex A (normative) Intraocular implantation test .12
Annex B (informative) Patient numbers for cli
...
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