EN ISO 16671:2003

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2003)

ISO 16671:2002 defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.
ISO 16671:2002 applies to ophthalmic irrigating solutions (OISs), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological or metabolic function.

Ophthalmische Implantate - Spüllösungen für die ophthalmische Chirurgie (ISO 16671:2003)

Implants ophtalmiques - Solutions d'irrigation pour la chirurgie ophtalmique (ISO 16671:2003)

L'ISO 16671:2002 définit des exigences en matière de sécurité dans les performances prévues, les attributs de conception, les évaluations précliniques et cliniques, la stérilisation, l'emballage des produits, l'étiquetage des produits et les informations données par le fournisseur.
L'ISO 16671:2002 s'applique aux solutions d'irrigation ophtalmique utilisées en chirurgie ophtalmique. Elles n'ont pas de fonction immunologique, pharmacologique ou métabolique primaire.

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2003)

General Information

• Status: Withdrawn
• Publication Date: 25-Nov-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 16671:2004 - Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2003)

Relations

• Replaced By: EN ISO 16671:2015 - Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
• Effective Date: 18-Dec-2013

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16671:2004
01-februar-2004
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2003)
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2003)
Ophthalmische Implantate - Spüllösungen für die ophthalmische Chirurgie (ISO
16671:2003)
Implants ophtalmiques - Solutions d'irrigation pour la chirurgie ophtalmique (ISO
16671:2003)
Ta slovenski standard je istoveten z: EN ISO 16671:2003
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 16671:2004 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16671:2004

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SIST EN ISO 16671:2004
EUROPEAN STANDARD
EN ISO 16671
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2003
ICS 11.040.70
English version
Ophthalmic implants - Irrigating solutions for ophthalmic surgery
(ISO 16671:2003)
Implants ophtalmiques - Solutions d'irrigation pour la Ophthalmische Implantate - Spüllösungen für die
chirurgie ophtalmique (ISO 16671:2003) ophthalmische Chirurgie (ISO 16671:2003)
This European Standard was approved by CEN on 3 November 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 16671:2003 E
worldwide for CEN national Members.

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SIST EN ISO 16671:2004
EN ISO 16671:2003 (E)
Foreword
The text of ISO 16671:2003 has been prepared by Technical Committee ISO/TC 172 "Optics
and optical instruments" of the International Organization for Standardization (ISO) and has
been taken over as EN ISO 16671:2003 by 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 May 2004, and conflicting national
standards shall be withdrawn at the latest by May 2004.
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 16671:2003 has been approved by CEN as EN ISO 16671:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
2

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SIST EN ISO 16671:2004
EN ISO 16671:2003 (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 10993-2 1992 Biological evaluation of medical EN ISO 10993-2 1998
devices - Part 2: Animal welfare
requirements
ISO 14155-1 2003 Clinical investigation of medical EN ISO 14155-1 2003
devices for human subjects - Part
1: General requirements
ISO 14155-2 2003 Clinical investigation of medical EN ISO 14155-2 2003
devices for human subjects - Part
2: Clinical investigation pla
...