1、BSI Standards PublicationBS EN ISO 11978:2014Ophthalmic optics Contactlenses and contact lens careproducts LabellingBS EN ISO 11978:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO11978:2014. It supersedes BS EN ISO 11978:2000 which is withdrawn.The UK p
2、articipation in its preparation was entrusted to TechnicalCommittee CH/172/9, Contact lenses and contact lens care products.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a c
3、ontract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 79988 4ICS 11.040.70Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the au
4、thority of theStandards Policy and Strategy Committee on 31 October 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11978 October 2014 ICS 11.040.70 English Version Ophthalmic optics - Contact lenses and contact lens care products -
5、Labelling (ISO 11978:2014) Optique ophtalmique - Lentilles de contact et produits dentretien des lentilles de contact - tiquetage (ISO 11978:2014) Einfhrendes Element - Haupt-Element - Ergnzendes Element (ISO 11978:2014) This European Standard was approved by CEN on 21 June 2014. CEN members are bou
6、nd 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 C
7、EN-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
8、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,
9、Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 B
10、russels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11978:2014 EBS EN ISO 11978:2014EN ISO 11978:2014 (E) 3 Foreword This document (EN ISO 11978:2014) has been prepared by Technical Committee ISO/TC 172 “Optics and pho
11、tonics” in collaboration with 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 April 2015, and conflictin
12、g national standards shall be withdrawn at the latest by April 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 sup
13、ersedes EN ISO 11978:2000. 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 Republi
14、c 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. Endorsement notice The text of ISO 11978:2014 has been appro
15、ved by CEN as EN ISO 11978:2014 without any modification. BS EN ISO 11978:2014ISO 11978:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Labelling requirements . 14.1 General . 14.2 Contact lenses 14.3 Conta
16、ct lens care products . 4Bibliography 7BS EN ISO 11978:2014ISO 11978:2014(E)ForewordISO (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 t
17、echnical 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 clos
18、ely 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 n
19、eeded 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 paten
20、t 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 i
21、n this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barri
22、ers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instrumentsThis second edition cancels and replaces the first edition (ISO 11978:2000), which has b
23、een technically revised.iv ISO 2014 All rights reservedBS EN ISO 11978:2014ISO 11978:2014(E)IntroductionThis International Standard attempts to harmonize requirements, whenever possible, for labelling of contact lenses and contact lens care products with national laws, regulations, or guidelines tha
24、t might exist in countries throughout the world. Where national laws and labelling requirements exist in countries for medical devices, they are often developed by legislative bodies or regulatory authorities independently from the development process for International Standards. Therefore, labellin
25、g requirements established by an individual country cannot always be readily integrated into International Standards.The information given in this International Standard provides a suitable framework for developing labelling for contact lenses and contact lens care products. Conformance to the eleme
26、nts herein is intended to be sufficient for developing appropriate labelling for countries without existing laws or regulations for medical device labelling. However, conformance with the elements of this International Standard might not be sufficient for full compliance with additional labelling re
27、quirements mandated by an individual country. Where national laws or regulations mandate additional labelling requirements or conflict with elements of this International Standard, the national law or regulation is intended to be followed and is intended to take precedence over the elements of this
28、voluntary International Standard.The manufacturer should provide more information to the contact lens professional upon request. ISO 2014 All rights reserved vBS EN ISO 11978:2014BS EN ISO 11978:2014Ophthalmic optics Contact lenses and contact lens care products Labelling1 ScopeThis International St
29、andard specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their accessories by both types of users of contact lenses: the eye care professional and the contact lens wearer.This Internat
30、ional Standard does not specify the format in which such information shall be provided.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For
31、undated references, the latest edition of the referenced document (including any amendments) applies.ISO 15223-1:2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsISO 18369-1, Ophthalmic optics Contact lenses Par
32、t 1: Vocabulary, classification system and recommendations for labelling specifications3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 18369-1 apply.4 Labelling requirements4.1 GeneralWhere practicable and possible, the information supplied by the man
33、ufacturer shall be provided in the language of the country in which the device is distributed. Where appropriate, this information should take the form of symbols. Symbols used shall conform to ISO 15223-1. Where a symbol is not described in ISO 15223-1, it shall be described in the documentation su
34、pplied with the device.Provided the minimum essential requirements are fulfilled, the manufacturer may use his discretion as to the format in which the information is provided, e.g. product-specific information either on the packaging for each unit or on the sales packaging, or in separated leaflets
35、, brochures, booklets, or generic handling guides. These may be supplied as hard copy, electronic format, video, etc.All symbols and written information shall be legible under an illumination of 215 lx with visual acuity of 20/30 (Visus 0,67).4.2 Contact lensesThe labelling shall include at least th
36、e following (indicated in Table 1 by an “X”), exceptions as noted.INTERNATIONAL STANDARD ISO 11978:2014(E) ISO 2014 All rights reserved 1BS EN ISO 11978:2014ISO 11978:2014(E)Table 1 Labelling requirements for contact lensesNo. ContentLabelInstructions for useCommentsPrimary containerSecondary packag
37、ing1 Name or trade name and address of manufacturercXaX X2 Detailed requirements for the user to identify the device and the contents of the packaging, such as:a) product identification and/or material name;X X Xb) contact lens parameters; X Xc) number of contact lenses; XaXd) packaging solution (e.
38、g. phosphate-buff-ered saline solution) and identification of any preservative if presentXaX XIn exceptional cases, if the size of the pri-mary container does not allow information regarding composi-tion of storage solu-tion, this information may be incorporated in the “Instructions for use”.3 The w
39、ord “Sterile” together with method of sterilizationX X XIf applicable4 Lot number prefixed by the word “LOT” or the symbol for “LOT”X X5 Expiry date X X6 The statement “For single use only”dXaX X If applicable7 The statement “Custom made device” XaX X If applicable8 Intended use or application X9 Th
40、e indication that the device is exclu-sively for use in a clinical investigation according to applicable regulationsXaX XIf applicable10 Any special storage and/or handling conditions (e.g. Do not freeze.); any spe-cial operating instructions (e.g. Do not use if tamper-evident seal is damaged.)XaX X
41、11 The statement “Attention: See instruc-tions for use.” or the recognized symbol (see ISO 15223-1:2012, 5.4.3)XaX12 Replacement frequency, e.g. daily dis-posable, weekly disposable, or monthly disposableXbXIf applicableaIf contact lenses are not supplied with a secondary packaging, the required inf
42、ormation shall be given on the primary container label.bIf the size of the secondary packaging does not allow the above information to be displayed, the relevant information shall appear on the “Instructions for use” leaflet.cIn those markets that require name and address of an authorized representa
43、tive, this information shall be included.dFor the countries of the European Union, EU Directive 93/42/EEC stipulates that “A manufacturers indication of single use must be consistent across the Community”. Note that for contact lenses, “single use” implies a single wearing period the maximum duratio
44、n of which will be specified by the manufacturer.2 ISO 2014 All rights reservedBS EN ISO 11978:2014ISO 11978:2014(E)No. ContentLabelInstructions for useCommentsPrimary containerSecondary packaging13 Schedule for wear, e.g. daily wear and/or extended wear, as applicableX14 Recommended and, if relevan
45、t, con-traindicated care regimensX15 Date of issue or the latest revision of the instruction for useX16 Contraindications, warnings, and precautions or any other information deemed necessary by the manufacturer for the safe use of his contact lensesa) Possible or known adverse reactions and side eff
46、ects, and instructions to the wearer on the action to be taken if a problem occursXb) Recommendations to follow the eye care professionals instructions for duration of use of the contact lens(es) on a daily basis, follow-up visits, and emergency proceduresXc) Any directions or information neces-sary
47、 for the safe use of contact lenses if they have not been worn for a length of timeXd) The information that contact lenses should be removed immediately after contact with noxious vapour, e.g. chemi-cal or hazardous substances, or hazard-ous environment with ocular impactXe) The information that dir
48、ect exposure of contact lenses to non-sterile water (e.g. tap water, whirlpool bath, swimming, participating in water sports) increases the risk of microbial infectionXf) The information that the use of non-sterile water (e.g. tap water) in the handling of contact lenses and contact lens cases incre
49、ases the risk of serious microbial infectionXg) Instructions on cleaning and mainte-nance of contact lenses and contact lens casesXaIf contact lenses are not supplied with a secondary packaging, the required information shall be given on the primary container label.bIf the size of the secondary packaging does not allow the above information to be displayed, the relevant information shall appear on the “Instructions for use” leaflet.cIn those markets that require name and address of an authorized representative, this information shall be incl
