EN ISO 16672:2003

Ophthalmic implants - Ocular endotamponades (ISO 16672:2003)

ISO 16672:2003 applies to ocular endotamponades (OEs), 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 OEs, ISO 16672:2003 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 16672:2003)

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 16672:2003)

L'ISO 16672:2002 s'applique aux produits de tamponnements 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 tamponnements endoculaires, l'ISO 16672:2002 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 16672:2003)

General Information

• Status: Withdrawn
• Publication Date: 31-Jan-2003
• Withdrawal Date: 25-Aug-2015
• 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: 26-Aug-2015
• Ref Project: SIST EN ISO 16672:2003 - Ophthalmic implants - Ocular endotamponades (ISO 16672:2003)

Relations

• Replaced By: EN ISO 16672:2015 - Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
• Effective Date: 18-Dec-2013

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16672:2003
01-september-2003
2þHVQLYVDGNLLPSODQWDWL±6UHGVWYD]DQRWUDQMRRþHVQRWDPSRQDGR,62

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

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SIST EN ISO 16672:2003

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SIST EN ISO 16672:2003
EUROPEAN STANDARD
EN ISO 16672
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2003
ICS 11.040.70
English version
Ophthalmic implants - Ocular endotamponades (ISO
16672:2003)
Implants ophtalmiques - Produits de tamponnement Ophthalmische Implantate - Okulare Endotamponaden
endoculaires (ISO 16672:2003) (ISO 16672:2003)
This European Standard was approved by CEN on 2 January 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16672:2003 E
worldwide for CEN national Members.

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SIST EN ISO 16672:2003
EN ISO 16672:2003 (E)
CORRECTED  2003-03-19
Foreword
This document (EN ISO 16672:2003) has been prepared by Technical Committee ISO/TC 172 "Optics
and optical instruments" 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 2003, and conflicting national standards shall
be withdrawn at the latest by August 2003.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg,
Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 16672:2003 has been approved by CEN as EN ISO 16672:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
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SIST EN ISO 16672:2003
EN ISO 16672:2003 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other publications.
These normative references are cited at the appropriate places in the text and the publications are listed
hereafter. For dated references, subsequent amendments to or revisions of any of these publications
apply to this European Standard only when incorporated in it by amendment or revision. For undated
references the latest edition of the publication referred to applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated by
(mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 10993-1 1997 Biological evaluation of medical devices - EN ISO 10993-1 1997
Part 1: Evaluation and testing
ISO 10993-2 1992 Biological evaluation of medical devices - EN ISO 10993-2 1998
Part 2: Animal welfare requirements
ISO 10993-6 1994 Biological evaluation of medical devices - EN 30993-6 1994
Part 6: Tests for local effects after
implantation
ISO 14630 1997 Non-active surgical implants - General EN ISO 14630 1997
requirements
ISO 14971 2000 Medical devices - Application of risk EN ISO 14971 2000
management to medical devices
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