EN ISO 18369-1-2017 en Ophthalmic optics - Contact lenses - Part 1 Vocabulary classification system and recommendations for labelling specifications.pdf

1、Ophthalmic optics Contact lensesPart 1: Vocabulary, classification system and recommendations for labelling specificationsBS EN ISO 18369-1:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 1

2、8369-1:2017. It is identical to ISO 18369-1:2017. It supersedes BS EN ISO 18369-1:2006+A1:2009, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172/9, Contact lenses and contact lens care products.A list of organizations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 committe

3、e can be obtained on request to its secretary.This publication 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 87557 1ICS 01.040.11;

4、 11.040.70Compliance with a British Standard cannot confer immunity from 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

5、ISO 18369-1:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 18369-1September 2017ICS 11.040.70 Supersedes EN ISO 18369-1:2006EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 20

6、17 CEN Ref. No. EN ISO 18369-1:2017: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersOphthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2017)Optique ophtalmique L

7、entilles de contact Partie 1: Vocabulaire, systme de classification et recommandations pour ltiquetage des spcifications (ISO 18369-1:2017)Augenoptik Kontaktlinsen Teil 1: Begriffe, Einteilung von Kontaktlinsenmaterialien und Empfehlungen fr die Schreibweise von Kontaktlinsenspezifikationen (ISO 183

8、69-1:2017)This European Standard was approved by CEN on 1 July 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 bibliographica

9、l 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

10、 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 Mace

11、donia, France, Germany, Greece, Hungary, 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 18369-1:2017 (E)European forewordThis docume

12、nt (EN ISO 18369-1:2017) has been prepared 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 publ

13、ication of an identical text or by endorsement, 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 r

14、esponsible for identifying any or all such patent rights.This document supersedes EN ISO 18369-1:2006.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,

15、 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey a

16、nd the United Kingdom.2BS EN ISO 18369-1:2017ISO 18369-1:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms, definitions and symbols 13.1 Terms and definitions . 13.2 Symbols 384 Classification of contact lens materials .39Annex A (informative) Specification of rigid contact

17、lenses .42Annex B (informative) Specification of soft contact lenses 52Bibliography .54Alphabetical index of terms .55 ISO 2017 All rights reserved iiiContents PageBS EN ISO 18369-1:2017ISO 18369-1:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of n

18、ational 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. Inter

19、national 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.The procedures used to develop this document and those inte

20、nded for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, 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 ww

21、w.iso.org/directives).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. Details of any patent rights identified during the development of the document

22、will be in the Introduction and/or on the ISO list of patent declarations received (see www.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 mean

23、ing of ISO specific terms and expressions related to conformity assessment, as well as information 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 Technic

24、al Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This second edition cancels and replaces the first edition (ISO 18369-1:2006), which has been technically revised. It also incorporates the Amendment ISO 18369-1:2006/Amd 1:2009.A list of all parts in

25、 the ISO 18369 series can be found on the ISO website.iv ISO 2017 All rights reservedBS EN ISO 18369-1:2017ISO 18369-1:2017(E)IntroductionThe ISO 18369 series applies to contact lenses, which are devices worn over the front surface of the eye in contact with the preocular tear film. This document co

26、vers rigid (hard) corneal and scleral contact lenses, as well as soft contact lenses. Rigid lenses maintain their own shape. Soft contact lenses are easily deformable and require support for proper shape.Clause 3 contains the terms and definitions primarily used in the contact lens field. A list of

27、terms having special symbols is given in Table 1.The list of terms and definitions does not include all ISO terms, definitions, and symbols used in the contact lens field. It is intended to be a convenient reference source from which the contents have been compiled from the text of this and other IS

28、O standards applicable to the manufacture, evaluation, measurement, labelling and marketing of contact lenses and contact lens care products. An alphabetical index was added for rapid finding of terms.Words are grouped under several topics by reference number according to the general category into w

29、hich each word logically fits. The preferred form of each term is listed on the first line after its reference number. Other admitted forms have been placed on subsequent lines after the preferred form. All admitted terms are given in bold-faced type. A few obsolete and superseded terms are listed f

30、or historical reference and convenience and to aid comprehension but are indicated as deprecated and are no longer to be used. Obsolete and superseded terms are not in bold-faced type so that they may be clearly identified as terms used historically.Contact lenses are primarily used for the correcti

31、on of refractive errors but they can also be used for therapeutic purposes and cosmetic reasons. The materials used are divided into two main categories, rigid and soft. The former is composed mainly of corneal lenses and to a lesser extent, scleral lenses. Both types can be made from gas-permeable

32、materials or non-gas permeable materials. Soft lenses are manufactured primarily from hydrogel materials. A small number of lenses incorporate both a rigid material and a soft material.In terms of vision correction, contact lenses can be made as single vision, bifocal, multifocal or progressive lens

33、es. Surface designs can be spherical, aspheric, toric or “complex”.Wearing modality can be daily wear, flexible wear, or extended wear. Typical replacement schedules for soft lenses are daily, two weekly, or monthly. Rigid lenses and some soft lenses are replaced less often, for example, once a year

34、. ISO 2017 All rights reserved vBS EN ISO 18369-1:2017This page deliberately left blankOphthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications1 ScopeThis document identifies and defines the terms applicable to the physical, chemical

35、 and optical properties of contact lenses, their manufacture and uses. It provides a vocabulary of terms and, when appropriate, the international symbol and abbreviation associated with a specific term. This document also defines the terms relating to contact lens care products. It also incorporates

36、 the classifications of contact lens materials and gives recommendations for the labelling of the specifications of contact lenses.2 Normative referencesThere are no normative references in this document.3 Terms, definitions and symbolsFor the purposes of this document, the following terms and defin

37、itions 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 3.1 Terms and definitions3.1.1 Basic terms 3.1.1.1contact lens

38、ophthalmic lens designed to be worn on the front surface of the eyeNote 1 to entry: This term includes contact lenses of plano power.3.1.1.2corneal contact lensintralimbal contact lenscontact lens (3.1.1.1) having a total diameter less than the visible iris diameter and designed to be worn in its en

39、tirety on the cornea3.1.1.3scleral contact lenscontact lens (3.1.1.1) whose scleral zone (3.1.5.12) is supported on the bulbar conjunctiva and whose optic zone (3.1.2.1.17) vaults over the corneaNote 1 to entry: Note1 to entry: In some cases, the back optic zone (3.1.2.2.1) will have minimal corneal

40、 touch.Note 2 to entry: Terms such as mini-scleral, semi-scleral and corneo-scleral can be found in the contact lens literature to describe lenses of different parameters.INTERNATIONAL STANDARD ISO 18369-1:2017(E) ISO 2017 All rights reserved 1BS EN ISO 18369-1:2017ISO 18369-1:2017(E)Note 3 to entry

41、: See 3.1.5 for specific terms concerning scleral contact lenses.3.1.1.4lenticular contact lenscontact lens (3.1.1.1) having a front optic zone (3.1.2.1.17) made smaller than the total diameterNote 1 to entry: This construction is conventionally used to reduce the centre thickness (3.1.2.4.1) of a p

42、ositive power contact lens (3.1.2.1.13) or reduce the edge (3.1.2.1.34) thickness of a negative power contact lens (3.1.2.1.14).3.1.1.5contact shellcontact lens (3.1.1.1) not designed to correct vision3.1.1.6scleral shellrigid contact shell (3.1.1.5) with a scleral zone (3.1.5.12) Note 1 to entry: S

43、ee 3.1.5 for specific terms concerning scleral shells.3.1.1.7rigid contact lenscontact lens (3.1.1.1) which, in its final state and under normal conditions, retains its form without support and has a water content (3.1.6.11) less than 10 %Note 1 to entry: Rigid lenses are made of non-hydrogel rigid

44、materials which can flex slightly but do not substantially conform to the shape of the cornea when on the eye.3.1.1.8rigid gas-permeable contact lensRGP contact lensDEPRECATED: hard gas-permeable contact lenscontact lens (3.1.1.1) manufactured from a rigid material containing one or more gas-permeab

45、le polymers in sufficient concentrations to facilitate transport of oxygen through the lens and having a Dk equal to or greater than 10 Dk unitsNote 1 to entry: For an explanation of the meaning of Dk and Dk units, see 3.1.6.8.3.1.1.9soft contact lenscontact lens (3.1.1.1) made of a hydrogel materia

46、l or non-hydrogel material which, in its hydrated final state and under normal conditions, contains a known water content (3.1.6.11), is easily deformable and may not retain its form without support3.1.1.10hydrogel contact lensDEPRECATED: hydrophilic contact lenscontact lens (3.1.1.1) made of water-

47、absorbing material having equilibrium water content (3.1.6.11) greater than or equal to 10 % in standard saline solution as specified in ISO 183693 at 20 C3.1.1.11composite contact lenscontact lens (3.1.1.1) composed of two or more different materialsEXAMPLE Laminated lens, fused segment lens, lens

48、with a rigid centre and a flexible periphery.3.1.1.12surface-treated contact lenscontact lens (3.1.1.1) whose surfaces have been modified to make the surface characteristics different to those of the bulk material2 ISO 2017 All rights reservedBS EN ISO 18369-1:2017ISO 18369-1:2017(E)3.1.1.13bifocal

49、contact lensmultifocal contact lens (3.1.1.14) having two optic zones (3.1.2.1.17), usually for distance and near-vision correctionNote 1 to entry: See 3.1.4 for specific terms concerning bifocal contact lenses.3.1.1.14multifocal contact lenscontact lens (3.1.1.1) designed to provide two or more zones of different corrective powersNote 1 to entry: See 3.1.4 for specific terms concerning multifocal contact lenses.3.1.1.15progressive power contact lensvarifocal power contact lenscontact lens (3.1.1.1) designed to provide correction for mor