prEN ISO 16671
(Main)Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671:2023)
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671:2023)
ISO 16671:2015 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 16671:2015 applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.
Ophthalmische Implantate - Spüllösungen für die ophthalmische Chirurgie (ISO/DIS 16671:2023)
Implants ophtalmiques - Solutions d'irrigation pour la chirurgie ophtalmique (ISO/DIS 16671:2023)
L'ISO 16671:2015 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 16671:2015 s'applique aux solutions d'irrigation ophtalmique utilisées en chirurgie ophtalmique. Elles n'ont pas de fonction immunologique, pharmacologique ou métabolique primaire.
Očesni vsadki (implantati) - Raztopine za izpiranje za očesno kirurgijo (ISO/DIS 16671:2023)
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 16671:2024
01-marec-2024
Očesni vsadki (implantati) - Raztopine za izpiranje za očesno kirurgijo (ISO/DIS
16671:2023)
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671:2023)
Ophthalmische Implantate - Spüllösungen für die ophthalmische Chirurgie (ISO/DIS
16671:2023)
Implants ophtalmiques - Solutions d'irrigation pour la chirurgie ophtalmique (ISO/DIS
16671:2023)
Ta slovenski standard je istoveten z: prEN ISO 16671
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 16671:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 16671:2024
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oSIST prEN ISO 16671:2024
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16671
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-12-21 2024-03-14
Ophthalmic implants — Irrigating solutions for ophthalmic
surgery
Implants ophtalmiques — Solutions d'irrigation pour la chirurgie ophtalmique
ICS: 11.040.70
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
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STANDARDS MAY ON OCCASION HAVE TO
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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 16671:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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oSIST prEN ISO 16671:2024
ISO/DIS 16671:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16671
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
Ophthalmic implants — Irrigating solutions for ophthalmic
surgery
Implants ophtalmiques — Solutions d'irrigation pour la chirurgie ophtalmique
ICS: 11.040.70
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
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NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 16671:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
© ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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oSIST prEN ISO 16671:2024
ISO/DIS 16671:2023(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance .
...
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