SIST EN ISO 14534:2015

Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)

ISO 14534:2011 specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses.
ISO 14534:2011 does not specify electrical safety and electromagnetic compatibility considerations that might arise from the use of electrical equipment in conjunction with contact lenses or contact lens care products.

Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen (ISO 14534:2011)

Diese Internationale Norm legt Anforderungen an die Sicherheit und Funktion von Kontaktlinsen, Kontaktlinsenpflegemitteln
und anderem Zubehör für Kontaktlinsen fest.
Diese Internationale Norm legt keine Anforderungen zur elektrischen Sicherheit und zur elektromagnetischen
Verträglichkeit fest, die sich möglicherweise durch den Gebrauch von elektrischen Geräten in Verbindung mit
Kontaktlinsen oder Kontaktlinsenpflegemitteln ergeben können.

Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Exigences fondamentales (ISO 14534:2011)

L'ISO 14534:2011 spécifie les exigences de sécurité et de performance s'appliquant aux lentilles de contact, produits d'entretien des lentilles de contact et autres accessoires utilisés avec les lentilles de contact.
L'ISO 14534:2011 ne traite pas de sécurité électrique ni de considérations de compatibilité électromagnétique potentiellement liées à l'utilisation d'équipements électriques avec les lentilles de contact et/ou les produits d'entretien pour lentilles de contact.

Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Temeljne zahteve (ISO 14534:2011)

ISO 14534:2011 določa varnostne in zmogljivostne zahteve glede kontaktnih leč, izdelkov za vzdrževanje kontaktnih leč in drugih dodatkov za kontaktne leče.
ISO 14534:2011 ne določa vidikov električne varnosti in elektromagnetne združljivosti, ki bi lahko nastali zaradi uporabe električne opreme v povezavi s kontaktnimi lečami ali izdelki za vzdrževanje kontaktnih leč.

General Information

• Status: Published
• Publication Date: 19-Apr-2015
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 04-Feb-2015
• Due Date: 11-Apr-2015
• Completion Date: 20-Apr-2015
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 14534:2015 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)

Relations

• Replaces: SIST EN ISO 14534:2011 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
• Effective Date: 01-May-2015

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen (ISO 14534:2011)Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Exigences fondamentales (ISO 14534:2011)Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 14534:2015SIST EN ISO 14534:2015en01-maj-2015SIST EN ISO 14534:2015SLOVENSKI
STANDARDSIST EN ISO 14534:20111DGRPHãþD



SIST EN ISO 14534:2015



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 14534
January 2015 ICS 11.040.70 Supersedes EN ISO 14534:2011English Version
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Exigences fondamentales (ISO 14534:2011)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen (ISO 14534:2011) This European Standard was approved by CEN on 7 January 2015.
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 CEN-CENELEC 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 CEN-CENELEC 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14534:2015 ESIST EN ISO 14534:2015



EN ISO 14534:2015 (E) 2 Contents Page Foreword .3 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices .5 SIST EN ISO 14534:2015



EN ISO 14534:2015 (E) 3 Foreword The text of ISO 14534:2011 has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 14534:2015 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 July 2015, and conflicting national standards shall be withdrawn at the latest by July 2015. 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. This document supersedes EN ISO 14534:2011. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN ISO 14534:2015



EN ISO 14534:2015 (E) 4 Table – Correlations between undated normative references and dated EN and ISO standards Normative references
Equivalent dated standard as listed in Clause 2 EN ISO ISO 10993-1 EN ISO 10993-1:2009 + AC:2010 ISO 10993-1:2009 + Cor.1:2010 ISO 11978 EN ISO 11978:2014 ISO 11978:2014 ISO 11980 EN ISO 11980:2012 ISO 11980:2012 ISO 11986 EN ISO 11986:2010 ISO 11986:2010 ISO 11987 EN ISO 11987:2012 ISO 11987:2012 ISO 13212 EN ISO 13212:2014 ISO 13212:2014 ISO 14155 EN ISO 14155:2011 + AC:2011 ISO 14155:2011 + Cor.1:2011 ISO 14729:2001 + Amd.1:2010 EN ISO 14729:2001 + A1:2010 ISO 14729:2001 + Amd.1:2010 ISO 14730 EN ISO 14730:2014 ISO 14730:2014 ISO 14971 EN ISO 14971:2007 ISO 14971:2007 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 ISO 18369-1 EN ISO 18369-1:2006 ISO 18369-1:2006 ISO 18369-2 EN ISO 18369-2:2012 ISO 18369-2:2012 ISO 22442 (all parts) EN ISO 22442-1:2007,
EN ISO 22442-2:2007,
EN ISO 22442-3:2007, — ISO 22442-1:2007, ISO 22442-2:2007, ISO 22442-3:2007, ISO/TR 22442-4:2010, Endorsement notice The text of ISO 14534:2011 has been approved by CEN as EN ISO 14534:2015 without any modification. SIST EN ISO 14534:2015



EN ISO 14534:2015 (E) 5 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on Medical Devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 — Correspondence between this European Standard
and Directive 93/42/EEC on Medical Devices Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4, 5, 10, 11 7.2
4, 7 7.3
4 7.5
4, 11 7.6
4, 10, 11 8.1
7 8.2
10, 11 8.3
9, 10 8.4
9, 10 8.5
11 8.6
11.4 8.7
4.2, 13.1 9.1 Sub-clause13.1 makes normative reference to EN ISO 11978. The relevant requirement for contact lenses is provided in EN ISO 11978:2014, Table 1, item 16 h). The relevant requirements for contact lens care products are provided in EN ISO 11978:2014, Table 2, items 10, 16, 19, 20, and 27. 5 9.2
4 10.1
SIST EN ISO 14534:2015



EN ISO 14534:2015 (E) 6 Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 13.1, 13.2, 13.3 13.1 Sub-clause13.1 makes normative reference to EN ISO 11978. The labelling requirements for contact lenses are provided in EN ISO 11978:2014, Table 1. The labelling requirements for contact lens care products are provided in EN ISO 11978:2014, Table 2. 13.1, 13.3.1 13.2 Sub-clause13.1 makes normative reference to EN ISO 11978. The relevant requirement is provided in EN ISO 11978:2014, sub-clause 4.1. 13.1, 13.2, 13.3 13.3 Sub-clause13.1 makes normative reference to EN ISO 11978. The labelling requirements for contact lenses are provided in EN ISO 11978:2014, Table 1. The labelling requirements for contact lens care products are provided in EN ISO 11978:2014, Table 2. 13.1, 13.2, 13.3 13.4 Sub-clause13.1 makes normative reference to EN ISO 11978. The labelling requirements on intended purpose for contact lenses are provided in EN ISO 11978:2014, Table 1. The labelling requirements on intended purpose for contact lens care products are provided in EN ISO 11978:2014, Table 2. 13.1, 13.2, 13.3 13.5 Sub-clause13.1 makes normative reference to EN ISO 11978. The relevant labelling requirements for contact lenses are provided in EN ISO 11978:2014, Table 1, items 2 and 4. The relevant labelling requirements for contact lens care products are provided in EN ISO 11978:2014, Table 2, items 2, 4 and 16. 13.1, 13.2, 13.3 13.6 Sub-clause13.1 makes normative reference to EN ISO 11978. The labelling requirements for contact lenses are provided in EN ISO 11978:2014, Table 1. The labelling requirements for contact lens care products are provided in EN ISO 11978:2014, Table 2. WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. SIST EN ISO 14534:2015



Reference numberISO 14534:2011(E)© ISO 2011
INTERNATIONAL STANDARD ISO14534Third edition2011-04-01Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements Optique ophtalmique — Lentilles de contact et produits d'entretien des lentilles de contact — Exigences fondamentales
SIST EN ISO 14534:2015



ISO 14534:2011(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.
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SIST EN ISO 14534:2015



ISO 14534:2011(E) © ISO 2011 – All rights reserved iii 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. ISO 14534 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 14534:2002), which has been technically revised. SIST EN ISO 14534:2015



ISO 14534:2011(E) iv © ISO 2011 – All rights reserved Introduction Currently, contact lenses and contact lens care products are regulated in different ways in different countries. This International Standard was mandated by the Commission of the European Communities to CEN and was originally developed by a joint ISO/CEN working group to ensure a global input; its first edition was ISO 14534:1997. It is possible that other requirements are now needed in certain countries outside the European Union. It is hoped that the adoption of the third edition of this International Standard will be yet another step towards the harmonization of standards and mutual recognition.
SIST EN ISO 14534:2015



INTERNATIONAL STANDARD ISO 14534:2011(E) © ISO 2011 – All rights reserved 1 Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements 1 Scope This International Standard specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. This International Standard does not specify electrical safety and electromagnetic compatibility considerations that might arise from the use of electrical equipment in conjunction with contact lenses or contact lens care products. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process ISO 11978, Ophthalmic optics — Contact lenses and contact lens care products — Information supplied by the manufacturer ISO 11980, Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations ISO 11986, Ophthalmic optics — Contact lenses and contact lens care products — Determination of preservative uptake and release ISO 11987, Ophthalmic optics — Contact lenses — Determination of shelf-life ISO 13212, Ophthalmic optics — Contact lens care products — Guidelines for determination of shelf-life ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice 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 ISO 14730, Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and guidance on determining discard date ISO 14971, Medical devices — Application of risk management to medical devices ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements SIST EN ISO 14534:2015



ISO 14534:2011(E) 2 © ISO 2011 – All rights reserved ISO 18369-1, Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications ISO 18369-2, Ophthalmic optics — Contact lenses — Part 2: Tolerances ISO 22442 (all parts), Medical devices utilizing animal tissues and their derivatives 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 18369-1 apply. 4 Safety and performance 4.1 The intended purpose of a contact lens, contact lens care product, or other accessory for contact lenses shall be documented. 4.2 The performance shall be demonstrated by an evaluation of existing information and history of human use, together with, if necessary, preclinical and clinical testing. In assessing safety and performance, each of the following shall be considered and the decisions shall be documented: a) functional characteristics, intended purpose, and conditions of use; b) specific requirements for rigid contact lenses and hydrogel contact lenses as specified in ISO 18369-2; c) microbiological properties, including bioburden, sterility, contact lens disinfection, and preservation activities (see Clause 10); d) biocompatibility, including extractable substances, cytotoxicity, irritation, sensitization, sterilization residues, and degradation products — the relevant requirements of ISO 10993-1 shall apply; e) clinical evaluation (see Clause 8); f) physical and chemical compatibility (including any preservative uptake and release) between contact lenses and contact lens care products, and other accessories for contact lenses as specified in ISO 11986; g) stability, including shelf-life and discard date (see Clause 12); h) other intended purposes, e.g. cleaning efficacy or measuring function. NOTE For test methods, see the references in Clause 2 and the Bibliography. 4.3 In the absence of a relevant International Standard, the manufacturer shall demonstrate that the product is in accordance with claimed properties, by valid scientific evidence from laboratory or clinical studies. NOTE Manufacturers of contact lenses and contact lens care products are reminded of traceability requirements as mentioned in International Standards on quality management. 5 Risk assessment 5.1 A formal risk assessment shall be carried out for each design of contact lens, contact lens care product or other accessory for contact lenses. Risk assessment shall be carried out using recognized methodology. The result of the risk assessment shall be documented for all aspects of safety, performance and labelling. ISO 14971 shall apply. SIST EN ISO 14534:2015



ISO 14534:2011(E) © ISO 2011 – All rights reserved 3 5.2 Each risk assessment shall be reviewed: a) regularly; b) whenever any changes are made to the product or its method of manufacture; c) whenever any changes are made to the packaging or labelling; d) whenever relevant new information becomes known to the manufacturer. 6 Design The design shall be documented, validated and verified to demonstrate that the required performance and safety are achieved when the product is used for its intended purpose. 7 Materials 7.1 Materials used for and during the manufacture of contact lenses, contact lens care products, and other accessories for contact lenses shall be chosen with regard to the properties necessary to meet the requirements for safety, performance, manufacture, handling, and compatibility with other materials wit
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