EN ISO 16672:2015

Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)

ISO 16672:2015 applies to ocular endotamponades (OE), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.
With regard to the safety and efficacy of OE, this International Standard 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 16672:2015)

Diese Internationale Norm befasst sich mit okularen Endotamponaden (OE), einer Klasse nicht-solider Implantate, die in der Ophthalmologie zur Glättung und zum Wiederanlegen einer abgelösten Netzhaut an die Aderhaut oder als Netzhauttamponade verwendet werden.
Mit Bezug auf die Sicherheit und Effektivität von OE legt diese Internationale Norm Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, vorklinische und klinische Prüfungen, Sterilisation, Verpackung, Kennzeichnung und die Bereitstellung von Informationen durch den Hersteller fest.

Implants ophtalmiques - Produits de tamponnement endoculaires (ISO 16672:2015)

L'ISO 16672:2015 s'applique aux produits de tamponnement endoculaires, un groupe d'implants non solides utilisés en ophtalmologie pour mettre à plat et repositionner une rétine décollée sur la choroïde, ou pour tamponner la rétine.
Tout en tenant compte de la sécurité et de l'efficacité des produits de tamponnement endoculaires, l'ISO 16672:2015 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 16672:2015)

Ta mednarodni standard se uporablja za sredstva za notranjo očesno tamponado (OE), tj. skupino vsadkov, ki niso v trdnem stanju, ki se uporabljajo v oftalmologiji za izravnavo in nameščanje mrežnice na horoideo, ali za tamponado mrežnice. Ta mednarodni standard določa zahteve glede varnosti in učinkovitosti sredstva za notranjo očesno tamponado za predvidene lastnosti, atribute načrtovanja, predklinično in klinično ocenjevanje, sterilizacijo, pakiranje izdelkov, označevanje izdelkov in informacije, ki jih dobavlja proizvajalec.

General Information

• Status: Withdrawn
• Publication Date: 25-Aug-2015
• Withdrawal Date: 12-Oct-2021
• 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
• Completion Date: 13-Oct-2021
• 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 16672:2015 - Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)

Relations

• Replaces: EN ISO 16672:2003 - Ophthalmic implants - Ocular endotamponades (ISO 16672:2003)
• Effective Date: 18-Dec-2013
• Replaced By: EN ISO 16672:2021 - Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16672:2015
01-oktober-2015
1DGRPHãþD
SIST EN ISO 16672:2003
2þHVQLYVDGNLLPSODQWDWL6UHGVWYD]DQRWUDQMRRþHVQRWDPSRQDGR,62

Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
Ophthalmische Implantate - Okulare Endotamponaden (ISO 16672:2015)
Implants ophtalmiques - Produits de tamponnement endoculaires (ISO 16672:2015)
Ta slovenski standard je istoveten z: EN ISO 16672:2015
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 16672:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16672:2015

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SIST EN ISO 16672:2015

EUROPEAN STANDARD
EN ISO 16672

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2015
ICS 11.040.70 Supersedes EN ISO 16672:2003
English Version
Ophthalmic implants - Ocular endotamponades (ISO
16672:2015)
Implants ophtalmiques - Produits de tamponnement Ophthalmische Implantate - Okulare Endotamponaden (ISO
endoculaires (ISO 16672:2015) 16672:2015)
This European Standard was approved by CEN on 7 May 2015.

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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16672:2015 E
worldwide for CEN national Members.

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SIST EN ISO 16672:2015
EN ISO 16672:2015 (E)
Contents Page
European foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .5
2

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SIST EN ISO 16672:2015
EN ISO 16672:2015 (E)
European foreword
This document (EN ISO 16672:2015) 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 February 2016, and conflicting national standards shall be withdrawn
at the latest by February 2016.
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 16672:2003.
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(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
The following referenced documents are indispensable for the application of this document. For undated
references, the latest edition of the referenced document (including any amendments) applies. For dated
references, only the edition cited applies. However, for any use of this standard ‘within the meaning of Annex
ZA’, the user should always check that any referenced document has not been superseded and that its
relevant contents can still be considered the generally acknowledged state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative
reference to the corresponding EN standard, if available, and otherwise to the d
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