oSIST prEN ISO 16671:2024

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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NATIONAL REGULATIONS.
ISO/DIS 16671:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 16671:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 16671:2023(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance .2
5 Design attributes .2
5.1 General . 2
5.2 Chemical description and contaminants . 2
5.3 Water used . 3
5.4 Characterization of the finished product. 3
5.4.1 General . 3
5.4.2 pH and buffering capacity . 3
5.4.3 Osmolality . 3
5.4.4 Spectral transmittance . 4
5.4.5 Particulates . 4
6 Design evaluation . 5
6.1 General . 5
6.2 Evaluation of biological safety . 5
6.2.1 General . 5
6.2.2 Bacterial endotoxins test . 5
6.2.3 Intraocular irritation and inflammation . 5
6.3 Clinical evaluation . 6
7 Sterilization . 6
8 Product stability . 6
9 Packaging. 7
9.1 Protection from damage during storage and transport. 7
9.2 Maintenance of sterility in transit . 7
10 Information supplied by the manufacturer . 7
Annex A (informative) Example of a suitable method for pH measurement and buffer
capacity determination . 9
Annex B (normative) Particulate contamination: Visible particulates .10
Annex C (informative) Light obscuration test method for particulate contamination: sub-
visible particles .11
Annex D (informative) Microscopic test method for particulate contamination: sub-visible
particles . . .13
Annex E (normative) Intraocular irrigation test .18
Annex F (normative) Clinical investigation .20
Annex G (informative) Analyses of OIS clinical data .22
Annex H (informative) Sample size calculation .24
Bibliography .26
iii
ISO/DIS 16671:2023(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
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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 rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 7, Ophthalmic optics and instruments.
This third edition cancels and replaces the second edition (ISO 16671:2015), which has been technically
revised.
The main changes are as follows:
— Inclusion of applicable sections from ISO 14630 throughout the document and removal of any
reference to that standard. It was further clarified that ophthalmic irrigation solutions (OIS) are
not implants by their intended use but are likely to share some of the risks related to non-active
implants. Therefore, the following clauses and subclauses have been revised: Clause 4 Intended
performance, Clause 5 Design attributes, Clause 7 Sterilization and Clause 9.1 Protection from
damage during storage and transport;
— Clarifications in Clause 3 Terms and definitions (3.1, 3.2, 3.3, 3.4);
— Revised Clause 5.1 General for a more accurate description of design attributes;
— Revised Clause 7 Sterilization to clarify the risks associated with components of OIS sterilized by
ethylene oxide (EO);
— Revised Clause 8 Product stability to clarify that the real time shelf-life testing shall be performed
and the accelerated shelf-life testing is optional;
— Revised Annex E Intraocular irrigation test to provide additional clarification regarding the number
of test and control eyes enrolled in the study and that use of medication during the study that could
possibly impact the study resu
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