EN ISO 16672:2021
(Main)Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)
Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)
This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.
With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.
Ophthalmische Implantate - Okulare Endotamponaden (ISO 16672:2020)
Dieses Dokument ist anwendbar für okulare Endotamponaden (OE), eine Klasse nicht-solider chirurgisch invasiver Medizinprodukte, die in dem Glaskörperraum zur Glättung und zum Anlegen einer abgelösten Retina an das retinale Pigmentepithel (RPE) oder als Retinatamponade verwendet werden.
Mit Bezug auf die Sicherheit und Effektivität von OE legt dieses Dokument Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, präklinische und klinische Bewertung, Sterilisation, Verpackung, Kenn¬zeichnung und die Bereitstellung von Informationen durch den Hersteller fest.
Implants ophtalmiques - Produits de tamponnement endoculaires (ISO 16672:2020)
Le présent document s'applique aux produits de tamponnement endoculaires, un groupe de dispositifs médicaux invasifs non solides de type chirurgical introduits dans la cavité vitréenne de l'œil pour mettre à plat et repositionner une rétine décollée sur l'épithélium pigmentaire rétinien (EPR), ou pour tamponner la rétine.
Tout en tenant compte de la sécurité et de l'efficacité des produits de tamponnement endoculaires, le présent document définit les exigences relatives à leurs performances attendues, à leurs données de conception, à une évaluation préclinique et clinique, à la stérilisation, au conditionnement du produit, à son étiquetage et aux informations fournies par le fabricant.
Očesni vsadki (implantati) - Sredstva za notranjo očesno tamponado (ISO 16672:2020)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2021
Nadomešča:
SIST EN ISO 16672:2015
Očesni vsadki (implantati) - Sredstva za notranjo očesno tamponado (ISO
16672:2020)
Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)
Ophthalmische Implantate - Okulare Endotamponaden (ISO 16672:2020)
Implants ophtalmiques - Produits de tamponnement endoculaires (ISO 16672:2020)
Ta slovenski standard je istoveten z: EN ISO 16672:2021
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 16672
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2021
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 16672:2015
English Version
Ophthalmic implants - Ocular endotamponades (ISO
16672:2020)
Implants ophtalmiques - Produits de tamponnement Ophthalmische Implantate - Okulare Endotamponaden
endoculaires (ISO 16672:2020) (ISO 16672:2020)
This European Standard was approved by CEN on 19 November 2019.
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.
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COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16672:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 16672:2021) 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 April 2022, and conflicting national standards shall be
withdrawn at the latest by April 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 16672:2015.
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 16672:2020 has been approved by CEN as EN ISO 16672:2021 without any modification.
INTERNATIONAL ISO
STANDARD 16672
Third edition
2020-06
Ophthalmic implants — Ocular
endotamponades
Implants ophtalmiques — Produits de tamponnement endoculaires
Reference number
ISO 16672:2020(E)
©
ISO 2020
ISO 16672:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ISO 16672:2020(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Intended performance . 3
5 Design attributes . 3
5.1 General . 3
5.2 Chemical description and contaminants . 3
5.3 Density . 4
5.4 Gaseous expansion . 4
5.5 Interfacial tension . 4
5.6 Kinematic viscosity . 4
5.7 Dynamic viscosity . 4
5.8 Molecular mass distribution . 4
5.9 Particulates. 5
5.10 Refractive index . 5
5.11 Spectral transmittance . 5
5.12 Surface tension . 5
5.13 Vapour pressure . 5
6 Design evaluation . 5
6.1 General . 5
6.2 Evaluation of biological safety . 6
6.2.1 General. 6
6.2.2 Bacterial endotoxins test . 6
6.2.3 Intraocular implantation test . 6
6.2.4 Ethylene oxide . 6
6.3 Clinical investigation . 7
7 Sterilization . 7
8 Product stability . 7
9 Integrity and performance of the delivery system . 7
10 Packaging . 8
10.1 Protection from damage during storage and transport. 8
10.2 Maintenance of sterility in transit . 8
11 Information supplied by the manufacturer . 8
Annex A (normative) Intraocular implantation test .10
Annex B (informative) Clinical investigation .11
Annex C (informative) Method for quantifying incompletely fluorinated contaminants in
perfluorocarbon liquids .14
Bibliography .16
ISO 16672:2020(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
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electrotechnical standardization.
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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. Details of
any patent right
...
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