EN ISO 14729:2001/A1:2010
(Amendment)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)
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
- Drafting 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.
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.
You can purchase EN ISO 14729:2001/A1:2010 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2010
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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)
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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
...
Le document standard SIST EN ISO 14729:2002/A1:2010 établit des exigences microbiologiques et des méthodes de test pour les produits de soin des lentilles de contact. Son champ d'application est clairement défini, se concentrant spécifiquement sur l'évaluation de l'activité antimicrobienne des produits destinés à la désinfection des lentilles de contact par des moyens chimiques, ainsi que sur les éléments faisant partie d'un régime de soin des lentilles de contact. Parmi ses points forts, ce standard fournit des méthodes de test rigoureuses pour assurer la sécurité et l'efficacité des produits. Cette approche méthodique garantit que les solutions utilisées par les utilisateurs sont non seulement efficaces contre les agents pathogènes mais aussi conformes aux normes internationales en matière de santé publique. Cela est particulièrement crucial dans le domaine de l'optique ophtalmique, où la composition et la manipulation des produits peuvent directement influencer la santé des yeux. La pertinence de la norme EN ISO 14729:2001/A1:2010 ne saurait être sous-estimée dans le cadre de la gestion hygiénique des lentilles de contact. En fournissant une base solide pour l'évaluation de produits, elle aide à prévenir les infections et à promouvoir une utilisation sécurisée des lentilles. Bien que la norme ne soit pas applicable à la gestion hygiénique des lentilles d'essai, son application aux produits commerciaux en fait un pilier essentiel pour les fabricants et les consommateurs. En résumé, cette norme internationale joue un rôle fondamental dans l'assurance qualité des produits de soin des lentilles de contact, ce qui contribue à la santé oculaire globale des utilisateurs.
The standard EN ISO 14729:2001/A1:2010 provides essential guidelines for the microbiological requirements and testing methods necessary for contact lens care products. The scope of this standard sets a clear framework for evaluating the antimicrobial efficacy of products intended for contact lens disinfection through chemical means, as well as other products integral to a comprehensive contact lens care regimen. One of the primary strengths of this standard lies in its rigorous specification of two distinct test methods designed to assess the antimicrobial activity of these products. These methods not only ensure that the products meet the necessary hygiene requirements but also help to enhance consumer safety by effectively managing microbial growth, thereby reducing the risk of infections associated with contact lens usage. Furthermore, the relevance of EN ISO 14729:2001/A1:2010 is significant as it addresses the growing concerns surrounding eye health and hygiene in an era where contact lens wear is increasingly prevalent. With the standard's clear delineation of applicable products, stakeholders in the industry-from manufacturers to healthcare professionals-can better navigate compliance and develop products that align with international safety expectations. The amendment A1:2010 updates the original 2001 standard, reflecting ongoing advancements in research and technology in the field of ophthalmic optics. By incorporating these updates, the standard remains contemporary and pertinent to current practices in the hygienic management of contact lenses. In summary, EN ISO 14729:2001/A1:2010 is a critical standard that effectively lays out the necessary microbiological requirements and test methods for contact lens care products, reinforcing the importance of hygiene in ocular health management.
SIST EN ISO 14729:2002/A1:2010 표준은 콘택트 렌즈 관리 제품의 미생물학적 요구사항 및 시험 방법에 대한 중요한 지침을 제공합니다. 이 표준의 주요 초점은 화학적 방법으로 콘택트 렌즈를 소독하기 위한 제품의 항균 활성을 평가하는 두 가지 시험 방법을 명시하는 것입니다. 이는 콘택트 렌즈 관리 요법의 일환으로 제품이 안전하고 효과적으로 사용될 수 있도록 보장합니다. 특히, EN ISO 14729:2001/A1:2010 표준은 제품과 요법의 위생 관리를 위한 필수적인 요구 사항을 규정함으로써 사용자 안전을 최우선으로 하고 있습니다. 이 표준은 콘택트 렌즈를 사용하는 소비자들에게 미생물에 의한 감염 위험을 줄이기 위한 과학적이고 체계적인 접근 방식을 제공합니다. 추가적으로, 이 표준은 시판되는 콘택트 렌즈 소독 제품의 품질과 신뢰성을 높이는 데 기여합니다. 따라서 산업 내에서 표준화를 통해 소비자 신뢰도를 향상시키는 데 중요한 역할을 수행하고 있습니다. EN ISO 14729:2001/A1:2010의 적용 범위는 연구 렌즈의 위생 관리를 제외하며, 실제 사용 제품에 대한 엄격한 테스트 요구를 강조합니다. 이러한 점에서 이 표준은 콘택트 렌즈 관리 제품의 안전성과 효과성을 보장하는 데 필수적인 기준 중 하나로 자리 잡고 있습니다. 결론적으로, SIST EN ISO 14729:2002/A1:2010 표준은 콘택트 렌즈 관리의 위생적 관리를 위한 중요한 지침으로서, 업계의 지속 가능한 발전에 기여하고 있으며, 사용자에게 안전한 제품 사용을 보장합니다.
EN ISO 14729:2001/A1:2010は、眼科光学におけるコンタクトレンズケア製品の微生物学的な要件と試験方法に関する国際標準として高く評価されています。この標準は、コンタクトレンズの化学的消毒を目的とした製品や、コンタクトレンズケアのための製品に対する抗菌活性を評価するための二つの試験方法を明確に定めています。 この規格の強みは、その科学的根拠に基づいた厳密な手法にあります。試験方法は、製品の効果を確実に評価できるように設計されており、消費者に安全で効果的なコンタクトレンズケア製品を提供するための基準を確立しています。また、この標準は、試験を行う際の一貫性と再現性を保証し、業界全体での製品の信頼性を向上させます。 EN ISO 14729:2001/A1:2010は、コンタクトレンズ関連の製品が市場で求められる衛生管理に関して、非常に重要な役割を果たしています。化学的手段による消毒が求められる今、消費者に安心して使用できる製品を提供するためには、この標準に基づく評価方法が不可欠です。 さらに、この標準は、トライアルレンズの衛生管理には適用されない旨を明記しており、明確な適用範囲を示しています。このことは、特定の市場ニーズや使用条件に対する誤解を減少させ、より適切な製品管理を促進します。 全体として、EN ISO 14729:2001/A1:2010は、コンタクトレンズケア製品の安全性と効率を確保するための信頼できる基準として、業界内での位置づけを強化しています。その包括的な内容と明確なガイドラインは、製品の品質向上に寄与し、消費者の信頼を築くための重要なツールと言えるでしょう。
Die Norm EN ISO 14729:2001/A1:2010 stellt einen wesentlichen Fortschritt im Bereich der ophthalmischen Optik dar, insbesondere in Bezug auf die Produkte zur Pflege von Kontaktlinsen. Als Ergänzung zum ursprünglichen Standard SIST EN ISO 14729:2002 legt die Norm spezifische mikrobiologische Anforderungen und Prüfmethoden fest, die für die hygienische Verwaltung von Kontaktlinsen von Bedeutung sind. Ein zentraler Aspekt der Norm ist die Definition von zwei Testmethoden zur Bewertung der antimikrobiellen Aktivität von Produkten, die zur Desinfektion von Kontaktlinsen vermarktet werden. Dies ist besonders relevant, da die Sicherheit und Hygiene von Kontaktlinsen eine grundlegende Voraussetzung für die Gesundheit der Benutzer darstellt. Die Norm stellt sicher, dass nur Produkte, die strengen mikrobiologischen Tests standhalten, auf dem Markt zugelassen werden, was das Risiko für Infektionen und andere gesundheitliche Probleme erheblich verringert. Ein weiterer Vorteil der EN ISO 14729:2001/A1:2010 ist die klare Abgrenzung der Anwendbarkeit. Die Norm ist speziell auf Produkte ausgerichtet, die Teil eines Pflegeriegimes für Kontaktlinsen sind, wodurch sichergestellt wird, dass die in die Norm aufgenommenen Prüfverfahren und Anforderungen direkt auf die tatsächliche Verwendung dieser Produkte abgestimmt sind. Es wird jedoch darauf hingewiesen, dass diese Norm nicht für die hygienische Verwaltung von Versuchslinsen gilt, was eine präzise Fokussierung auf den Endverbrauchermarkt ermöglicht. Die Relevanz dieser Norm kann nicht unterschätzt werden, insbesondere in Zeiten zunehmender Fälle von bakterienbedingten Komplikationen im Zusammenhang mit Kontaktlinsen. Durch die Implementierung dieser Standards können Hersteller und Händler ein höheres Maß an Verantwortung und Qualitätssicherung übernehmen, was letztlich den Verbraucherschutz stärkt. Insgesamt zeigt die EN ISO 14729:2001/A1:2010 durch ihre umfangreichen Anforderungen und Testmethoden und die klare Fokussierung auf Hygienemanagement eine bedeutende Stärkung der Qualitätsstandards im Bereich der Kontaktlinsenpflege und stellt somit einen wichtigen Beitrag zur Sicherheit der Benutzer dar.
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