1、Ophthalmic optics - Contact lenses and contact lens care products - Labelling BS EN ISO 11978:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 11978:2017. It is identical to ISO 11978:2017.
2、It supersedes BS EN ISO 11978:2014, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172/9, Contact lenses and contact lens care products.A list of organizations represented on this committee can be obtained on request to its secretary.This publicati
3、on does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 96379 7ICS 11.040.70Compliance with a British Standard cannot confer immunity fro
4、m legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 11978:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 119
5、78September 2017ICS 11.040.70 Supersedes EN ISO 11978:2014EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 11978:2017: EAll rights of exploitation in any form an
6、d by any means reserved worldwide for CEN national MembersOphthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017)Optique ophtalmique - Lentilles de contact et produits dentretien des lentilles de contact - tiquetage (ISO 11978:2017)This European Standard was ap
7、proved by CEN on 8 September 2017.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 natio
8、nal 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 languag
9、e 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, Hu
10、ngary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 11978:2017 (E)European forewordThis document (EN ISO 11978:2017) has been prep
11、ared by Technical Committee ISO/TC 172 “Optics and photonics” 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 end
12、orsement, at the latest by March 2018, and conflicting national standards shall be withdrawn at the latest by March 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all
13、such patent rights.This document supersedes EN ISO 11978:2014.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, Estoni
14、a, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement notice
15、The text of ISO 11978:2017 has been approved by CEN as EN ISO 11978:2017 without any modification.2BS EN ISO 11978:2017ISO 11978:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Labelling requirements . 14.1 General . 14.2 Contact lenses 24.3 Contact le
16、ns care products . 3Bibliography 6 ISO 2017 All rights reserved iiiContents PageBS EN ISO 11978:2017ISO 11978:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standa
17、rds 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 tak
18、e 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 par
19、ticular 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
20、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 w
21、ww.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 on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as in
22、formation about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: 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 i
23、nstruments. This third edition cancels and replaces the second edition (ISO 11978:2014), of which it constitutes a minor revision.The following change has been done:In 4.1, paragraph 3“All symbols and written information shall be legible under an illumination of 215 lx with visual acuity of 20/30 (V
24、isus 0,67).“has been replaced with“All symbols and written information shall be a minimum of 0,7 mm in height and be legible at a reading distance of 30 cm under the illumination of 215 lx, except for Trademarks and any manufacturing part numbers.“iv ISO 2017 All rights reservedBS EN ISO 11978:2017I
25、SO 11978:2017(E)IntroductionThis document attempts to harmonize requirements, whenever possible, for labelling of contact lenses and contact lens care products with national laws, regulations, or guidelines that might exist in countries throughout the world. Where national laws and labelling require
26、ments 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, labelling requirements established by an individual country cannot always be readily integrated in
27、to International Standards.The information given in this document provides a suitable framework for developing labelling for contact lenses and contact lens care products. Conformance to the elements herein is intended to be sufficient for developing appropriate labelling for countries without exist
28、ing laws or regulations for medical device labelling. However, conformance with the elements of this document might not be sufficient for full compliance with additional labelling requirements mandated by an individual country. Where national laws or regulations mandate additional labelling requirem
29、ents or conflict with elements of this document, the national law or regulation is intended to be followed and is intended to take precedence over the elements of this voluntary document.The manufacturer should provide more information to the contact lens professional upon request. ISO 2017 All righ
30、ts reserved vBS EN ISO 11978:2017This page deliberately left blankOphthalmic optics - Contact lenses and contact lens care products - Labelling 1 ScopeThis document specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and
31、 safe use of these devices and their accessories by both types of user of contact lenses: the eye care professional and the contact lens wearer.This document does not specify the format in which such information shall be provided.2 Normative referencesThe following documents are referred to in the t
32、ext in such a way that some or all of their content constitutes requirements 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 15223-1:2012, Medical devices Symbols to b
33、e used with medical device labels, labelling and information to be supplied Part 1: General requirementsISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications3 Terms and definitionsFor the purposes of this document, th
34、e terms and definitions given in ISO 183691 apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp 4 Labelling requirements4
35、.1 GeneralWhere practicable and possible, the information supplied by the manufacturer 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 152231. Where a symbol is
36、 not described in ISO 152231, it shall be described in the documentation supplied 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
37、packaging for each unit or on the sales packaging, or in separated leaflets, brochures, booklets, or generic handling guides. These may be supplied as hard copy, electronic format, video, etc.All symbols and written information shall be a minimum of 0,7 mm in height and be legible at a reading dista
38、nce of 30 cm under the illumination of 215 lx, except for Trademarks and any manufacturing part numbers.INTERNATIONAL STANDARD ISO 11978:2017(E) ISO 2017 All rights reserved 1BS EN ISO 11978:2017ISO 11978:2017(E)4.2 Contact lensesThe labelling shall include at least the following (indicated in Table
39、 1 by an “X”), exceptions as noted.Table 1 Labelling requirements for contact lensesNo. ContentLabelInstructions for useCommentsPrimary containerSecondary packaging1 Name or trade name and address of manufacturercXaX X2 Detailed requirements for the user to identify the device and the contents of th
40、e packaging, such as:a) product identification and/or material name;X X Xb) contact lens parameters; X X c) number of contact lenses; XaX d) packaging solution (e.g. phosphate- buffered saline solution) and identification of any preservative if presentXaX XIn exceptional cases, if the size of the pr
41、imary container does not allow information regarding compo-sition of storage solution, this information may be incorporated in the “Instructions for use”.3 The word “Sterile” together with method of sterilizationX X X If applicable4 Lot number prefixed by the word “LOT” or the symbol for “LOT”X X 5
42、Expiry date X X 6 The statement “For single use only”dXaX X If applicable7 The statement “Custom made device” XaX X If applicable8 Intended use or application X9 The indication that the device is exclusively for use in a clinical investigation according to applicable regulationsXaX X If applicable10
43、 Any special storage and/or handling con-ditions (e.g. Do not freeze.); any special operating instructions (e.g. Do not use if tamper-evident seal is damaged.)XaX X11 The statement “Attention: See instruc-tions for use.” or the recognized symbol (see ISO 15223-1:2012, 5.4.3)XaX 12 Replacement freque
44、ncy, e.g. daily dis-posable, weekly disposable, or monthly disposableXbX If applicable13 Schedule for wear, e.g. daily wear and/or extended wear, as applicableX2 ISO 2017 All rights reservedBS EN ISO 11978:2017ISO 11978:2017(E)No. ContentLabelInstructions for useCommentsPrimary containerSecondary pa
45、ckaging14 Recommended and, if relevant, contra-indicated care regimensX15 Date of issue or the latest revision of the instruction for useX16 Contraindications, warnings and precau-tions or any other information deemed necessary by the manufacturer for the safe use of his contact lensesa) Possible or
46、 known adverse reactions and side effects, 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
47、directions or information necessary 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. chemical or hazardous substances, or hazardous environment with ocular i
48、mpactXe) The information that direct 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-ster-ile water (e.g. tap water) in the handling of contact l
49、enses and contact lens cases increases the risk of serious microbial infectionXg) Instructions on cleaning and maintenance of contact lenses and contact lens casesXh) Instruction not to change the contact lens care system without consulting an eye care professionalXi) Instruction not to change lens type or parameters without consulting an eye care professionalXj) Instructions regarding the hygienic han-dling of contact lensesXk) Instructions for insertion and removal of contact lensesX4.3 Contact lens care productsThe labelling shall include at
