Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses - Amendment 1 (ISO 14729:2001/Amd 1:2010)

Amandma A1:2010 je dodatek k standardu SIST EN ISO 14729:2002
This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are part of a contact lens care regimen. This International Standard is not applicable to the hygienic management of trial lenses.

Augenoptik - Kontaktlinsenpflegemittel - Mikrobiologische Anforderungen und Prüfverfahren für Produkte und Systeme zum Hygienemanagement von Kontaktlinsen - ÄNDERUNG 1 (ISO 14729:2001/Amd.1:2010)

Optique ophtalmique - Produits d'entretien des lentilles de contact - Exigences microbiologiques et méthodes d'essai des produits et protocoles d'entretien des lentilles de contact - Amendement 1 (ISO 14729:2001/Amd 1:2010)

Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Mikrobiološke zahteve in preskusne metode za izdelke in postopki higienskega ravnanja s kontaktnimi lečami - Dopolnilo A1 (ISO 14729:2001/Amd 1:2010)

Amandma A1:2010 je dodatek k standardu SIST EN ISO 14729:2002
Ta mednarodni standard določa dve preskusni metodi za vrednotenje antimikrobne dejavnosti izdelkov, ki se tržijo za razkuževanje kontaktnih leč s kemičnimi sredstvi in izdelkov, ki so del postopkov nege kontaktnih leč. Ta mednarodni standard ne velja za higiensko ravnanje s poskusnimi lečami.

General Information

Status
Published
Publication Date
30-Sep-2010
Withdrawal Date
29-Apr-2011
Technical Committee
CEN/TC 170 - Ophthalmic optics
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
01-Oct-2010
Due Date
20-May-2011
Completion Date
01-Oct-2010

Relations

Effective Date
22-Dec-2008

Overview

EN ISO 14729:2001/A1:2010 is an important amendment to the international standard defining microbiological requirements and test methods for contact lens care products. This amendment ensures that such products meet stringent hygienic management criteria to prevent microbial contamination and infection risks associated with contact lens usage. Developed by ISO/TC 172 and endorsed by the European Committee for Standardization (CEN), it serves as the authoritative guide for manufacturers and regulators in the field of ophthalmic optics.

This standard focuses on the microbiological efficacy of care products, including disinfectant solutions and cleansing regimens, verifying their ability to reduce or control microbial contamination on contact lenses. It addresses both primary and secondary antimicrobial criteria, incorporating the presence of organic soil to simulate real-world conditions.

Key Topics

  • Microbiological Performance Criteria
    Outlines required log reductions of bacteria, moulds, and yeasts within specific soaking periods, ensuring effective microbial control. For instance, a minimum of 90% reduction (1.0 log) in moulds and yeasts is required, with no microbial growth observed beyond four times the recommended soaking period.

  • Test Methods
    Includes stand-alone and regimen tests, assessing contact lens care products individually and within full cleaning regimens. Products not using mechanical cleaning (rubbing) or rinsing steps must meet enhanced secondary criteria under simulated organic soil conditions.

  • Lens Compatibility and Testing Samples
    Specifies use of various lens types such as silicon hydrogel, low/high water content, and fluorosilicone acrylate lenses to ensure broad compatibility. Test inoculation requires multiple lenses per microbial species to guarantee comprehensive validation.

  • Organic Soil Considerations
    Requires evaluation in the presence of organic material to accurately reflect the clinical environment of lens wearers, enhancing reliability and safety of the antimicrobial claims.

  • Updated Normative References
    Replaces older ISO references with the current ISO 18369-1 vocabulary and classification, ensuring consistent terminology and harmonization with existing ophthalmic standards.

Applications

  • Manufacturers of Contact Lens Care Products
    Use this standard to design and validate disinfectant solutions, cleaning agents, and complete care regimens that meet international microbiological safety criteria.

  • Regulatory Bodies and Certification Organizations
    Utilize EN ISO 14729:2001/A1:2010 as a benchmark for evaluating product safety, efficacy, and compliance before market approval.

  • Clinical and Optical Practitioners
    Reference the standard to recommend safe lens care protocols that minimize risk of microbial keratitis and other infections.

  • Research and Development
    Provides a scientifically validated methodology for testing new antimicrobial agents and care regimen innovations under realistic use conditions.

Related Standards

  • ISO 18369-1: Ophthalmic optics - Contact lenses - Part 1
    Defines vocabulary and classification systems integral to understanding and implementing microbiological safety standards.

  • EN ISO 14729:2001 (Original Standard)
    The base document establishing microbiological criteria prior to this amendment, forming the foundation for hygienic management in contact lens care.

  • ISO/IEC Directives, Part 2
    Guides the drafting and approval process for international standards including amendments like EN ISO 14729:2001/A1:2010.


By adhering to EN ISO 14729:2001/A1:2010, manufacturers and health professionals ensure contact lens users benefit from effective disinfection and hygienic management, significantly reducing risks linked to microbial contamination. This amendment reinforces best practices in ophthalmic care product development and safety evaluation, aligning with modern clinical requirements and evolving lens technologies.

Amendment

EN ISO 14729:2002/A1:2010

English language
10 pages
Preview
Preview
e-Library read for
1 day

Frequently Asked Questions

EN ISO 14729:2001/A1:2010 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses - Amendment 1 (ISO 14729:2001/Amd 1:2010)". This standard covers: Amandma A1:2010 je dodatek k standardu SIST EN ISO 14729:2002 This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are part of a contact lens care regimen. This International Standard is not applicable to the hygienic management of trial lenses.

Amandma A1:2010 je dodatek k standardu SIST EN ISO 14729:2002 This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are part of a contact lens care regimen. This International Standard is not applicable to the hygienic management of trial lenses.

EN ISO 14729:2001/A1:2010 is classified under the following ICS (International Classification for Standards) categories: 07.100.10 - Medical microbiology; 11.040.70 - Ophthalmic equipment; 11.080.20 - Disinfectants and antiseptics. The ICS classification helps identify the subject area and facilitates finding related standards.

EN ISO 14729:2001/A1:2010 has the following relationships with other standards: It is inter standard links to EN ISO 14729:2001. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN ISO 14729:2001/A1:2010 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


SLOVENSKI STANDARD
01-december-2010
2þHVQDRSWLND.RQWDNWQHOHþHLQL]GHONL]DY]GUåHYDQMHNRQWDNWQLKOHþ
0LNURELRORãNH]DKWHYHLQSUHVNXVQHPHWRGH]DL]GHONHLQSRVWRSNLKLJLHQVNHJD
UDYQDQMDVNRQWDNWQLPLOHþDPL'RSROQLOR$ ,62$PG
Ophthalmic optics - Contact lens care products - Microbiological requirements and test
methods for products and regimens for hygienic management of contact lenses -
Amendment 1 (ISO 14729:2001/Amd 1:2010)
Augenoptik - Kontaktlinsenpflegemittel - Mikrobiologische Anforderungen und
Prüfverfahren für Produkte und Systeme zum Hygienemanagement von Kontaktlinsen -
Änderung 1 (ISO 14729:2001/AM 1:2010)
Optique ophtalmique - Produits d'entretien des lentilles de contact - Exigences
microbiologiques et méthodes d'essai des produits et protocoles d'entretien des lentilles
de contact - Amendement 1 (ISO 14729:2001/Amd 1:2010)
Ta slovenski standard je istoveten z: EN ISO 14729:2001/A1:2010
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 14729:2001/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2010
ICS 11.040.70
English Version
Ophthalmic optics - Contact lens care products - Microbiological
requirements and test methods for products and regimens for
hygienic management of contact lenses - Amendment 1 (ISO
14729:2001/AM 1:2010)
Optique ophtalmique - Produits d'entretien des lentilles de Augenoptik - Kontaktlinsenpflegemittel - Mikrobiologische
contact - Exigences microbiologiques et méthodes d'essai
Anforderungen und Prüfverfahren für Produkte und
des produits et protocoles d'entretien des lentilles de Systeme zum Hygienemanagement von Kontaktlinsen -
contact - Amendement 1 (ISO 14729:2001/AM 1:2010) Änderung 1 (ISO 14729:2001/AM 1:2010)
This amendment A1 modifies the European Standard EN ISO 14729:2001; it was approved by CEN on 30 September 2010.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references concerning such
national standards may be obtained on application to the CEN Management Centre or to any CEN member.

This amendment 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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14729:2001/A1:2010: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
The text of this Amendment EN ISO 14729:2001/A1:2010 to the EN ISO 14729 from Technical Committee
ISO/TC 172 “Optics and photonics” of the International Organization for Standardization (ISO) has been taken
over as an amendment to the European Standard by Technical Committee CEN/TC 170 “Ophthalmic optics”
the secretariat of which is held by DIN.
This Amendment to the European Standard EN ISO 14729:2001 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by April 2011, and
conflicting national standards shall be withdrawn at the latest by April 2011.
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.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 14729:2001/Amd.1:2010 has been approved by CEN as a EN ISO 14729:2001/A1:2010
without any modification.
INTERNATIONAL ISO
STANDARD 14729
First edition
2001-04-15
AMENDMENT 1
2010-10-01
Ophthalmic optics — Contact lens care
products — Microbiological requirements
and test methods for products and
regimens for hygienic management of
contact lenses
AMENDMENT 1
Optique ophtalmique — Produits d'entretien des lentilles de contact —
Exigences microbiologiques et méthodes d'essai des produits et
protocoles d'entretien des lentilles de contact
AMENDEMENT 1
Reference number
ISO 14729:2001/Amd.1:2010(E)
©
ISO 2010
ISO 14729:2001/Amd.1:2010(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

©  ISO 2010
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2010 – All rights reserved

ISO 14729:2001/Amd.1:2010(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
Amendment 1 to ISO 14729:2001 was prepared by Technical Committee ISO/TC 172, Optics and photonics,
Subcommittee SC 7, Ophthalmic optics and instruments.

ISO 14729:2001/Amd.1:2010(E)
Ophthalmic optics — Contact lens care products —
Microbiological requirements and test methods for products
and regimens for hygienic management of contact lenses
AMENDMENT 1
Page 1, Normative references
Replace references to ISO 8320-1
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

Loading comments...