EN ISO 18369-1-2006 en Ophthalmic optics - Contact lenses - Part 1 Vocabulary classification system and recommendations for labelling specifications (Incorporates Amendment A1 2009.pdf

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1、BRITISH STANDARD BS EN ISO 18369-1:2006 Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications ICS 01.040.11; 11.040.70 +A1:2009BS EN ISO 18369-1:2006 This British Standard was published under the authority of the Standards Policy

2、and Strategy Committee on 31 October 2006 BSI 2009 National foreword The UK participation in its preparation was entrusted by Technical Committee CH/172, Ophthalmic optics, to Subcommittee CH/172/9, Contact lenses and contact lens care products. A list of organizations represented on this subcomitte

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. Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard is the UK

4、 implementation of EN ISO 18369-1:2006+A1:2009. It is identical with ISO 18369-1:2006, incorporating amendment 1:2009. It supersedes BS EN ISO 18369-1:2006 which is withdrawn. Date Comments Implementation of ISO amendment 1:2009 with CEN endorsement A1:2009. Insertion of row V and footnote into Tabl

5、e 2 ISBN 978 0 580 62087 4 +A1:2009 Amendments /corrigenda issued since publication 30 June 2009 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18369-1 ICS 01.040.11; 11.040.70 Supersedes EN ISO 8320-1:2003, EN ISO 8320-2:2001 and EN ISO 11539:1999,and partly supersedes EN ISO 8321-1:2002

6、and EN ISO 8321-2:2000 English Version Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2006) Optique ophtalmique - Lentilles de contact - Partie 1: Vocabulaire, systme de classification et recommandations po

7、ur ltiquetage des spcifications (ISO 18369-1:2006) Augenoptik - Kontaktlinsen - Teil 1: Begriffe, Einteilung von Kontaktlinsenmaterialien und Empfehlungen fr die Schreibweise von Kontaktlinsenspezifikationen (ISO 18369- 1:2006) This European Standard was approved by CEN on 19 May 2006. CEN members a

8、re 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

9、 the Central Secretariat 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 Central Secretariat has the same s

10、tatus as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slova

11、kia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reserved worldwid

12、e for CEN national Members. Ref. No. EN ISO 18369-1:2006: E :2006+A1 February 2009 Foreword This document (EN ISO 18369-1:2006) 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 whic

13、h 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 February 2007, and conflicting national standards shall be withdrawn at the latest by February 2007. This document supersedes EN I

14、SO 8320-1:2003, EN ISO 8320-2:2001 and EN ISO 11539:1999 and partly supersedes EN ISO 8321-1:2002 and EN ISO 8321-2:2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium

15、, 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. Endorsement notice The text of ISO

16、18369-1:2006 has been approved by CEN as EN ISO 18369-1:2006 without any modifications. NOTE: A-Deviations are given in Annex ZA (informative) Foreword to amendment A1 This Amendment (EN ISO 18369-1:2006/A1:2009) has been prepared by Technical Committee ISO/TC 172 Optics and optical instruments in c

17、ollaboration with Technical Committee This Amendment to the European Standard EN ISO 18369:2006 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2009, and conflicting national standards shall be withdrawn at the l

18、atest by August 2009. 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

19、standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Polan

20、d, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 18369-1:2006/Amd 1:2009 has been approved by CEN as a EN ISO 18369-1:2006/A1:2009 without any modification. “ “ “ “ BS EN ISO 18369-1:2006+A1:2009 CEN/TC 170 Ophthalmic opt

21、ics the secretariat of which is held by DIN. i i EN ISO 18369-1:2006+A1:2009 Contents Page Introduction v 1 Scope. 1 2 Terms, definitions and symbols 1 2.1 Terms and definitions . 1 2.1.1 Basic terms. 1 2.1.2 Contact lens parameters and design . 3 2.1.3 Aspheric contact lenses 15 2.1.4 Bifocal and m

22、ultifocal contact lenses 16 2.1.5 Scleral contact lenses and shells. 18 2.1.6 Contact lens material properties 20 2.1.7 Tinted contact lenses 23 2.1.8 Contact lens manufacture. 23 2.1.9 Packaging and labelling of contact lenses and contact lens care products . 23 2.1.10 Contact lens usage and wear m

23、odality 25 2.1.11 Contact lens hygienic management and contact lens care products 26 2.1.12 Miscellaneous. 29 2.2 Symbols 31 3 Classification of contact lens materials. 32 Annex A (informative) Specification of rigid contact lenses . 35 Annex B (informative) Specification of soft contact lenses. 43

24、Bibliography . 45 Alphabetical index . 47 Annex ZA (informative) A-deviations 46 BS EN ISO 18369-1:2006+A1:2009iii EN ISO 18369-1:2006+A1:2009blank Introduction The ISO 18369 series applies to contact lenses, which are devices worn over the front surface of the eye in contact with the preocular tear

25、 film. This part of ISO 18369 covers rigid (hard) corneal and scleral contact lenses, as well as soft contact lenses. Rigid lenses maintain their own shape unsupported and are made of transparent optical-grade plastics, such as polymethylmethacrylate (PMMA), cellulose acetate butyrate (CAB), polyacr

26、ylate/siloxane copolymers, rigid polysiloxanes (silicone resins), butylstyrenes, fluoropolymers, and fluorosiloxanes, etc. Soft contact lenses are easily deformable and require support for proper shape. A very large subset of soft contact lenses consists of transparent hydrogels containing water in

27、concentrations greater than 10 %. Soft contact lenses can also be made of non-hydrogel materials, e.g. flexible polysiloxanes (silicone elastomers). The ISO 18369 series is applicable to determining allowable tolerances of parameters and properties important for proper functioning of contact lenses

28、as optical devices. The ISO 18369 series includes tolerances for single vision contact lenses, bifocal lenses, lenses that alter the flux density and/or spectral composition of transmitted visible light (tinted or pigmented contact lenses, such as those with enhancing, handling, and/or opaque tints)

29、, and lenses that significantly attenuate ultraviolet radiation (UVR absorbing lenses). The ISO 18369 series covers contact lenses designed with spherical, toric, and aspheric surfaces, and recommended methods for the specification of contact lenses. The vocabulary portion (2.1) of this part of ISO

30、18369 contains the terms and definitions primarily used in the contact lens field. A list of 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

31、reference source from which the contents have been compiled from the text of this and other ISO 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. Word

32、s are grouped under several topics by reference number according to the general category into which each word logically fitted. 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.

33、All admitted terms are given in bold-faced type. A few obsolete and superseded terms are listed for historical reference and convenience and as an aid to 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

34、may be clearly identified as terms used historically. Figure 1 gives a schema of the classification and provides examples. It does not take into account all possible characteristics (hence resulting qualifiers) used in contact lens designation. Combinations of more than one qualifier are often used

35、in contact lens designation. BS EN ISO 18369-1:2006+A1:2009 v EN ISO 18369-1:2006+A1:2009 Figure 1 Classification of contact lenses according to various characteristics leads to various qualifiers used in their designation BS EN ISO 18369-1:2006+A1:2009 vi EN ISO 18369-1:2006+A1:2009 1 Ophthalmic op

36、tics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications 1 Scope This part of ISO 18369 identifies and defines the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a voca

37、bulary of terms and, when appropriate, the international symbol and abbreviation associated with a specific term. This part of ISO 18369 also defines the terms relating to contact lens care products. It also incorporates the classifications of contact lens materials and gives recommendations for the

38、 labelling of the specifications of contact lenses. 2 Terms, definitions and symbols 2.1 Terms and definitions 2.1.1 Basic terms 2.1.1.1 contact lens any ophthalmic lens designed to be worn on the front surface of the eye NOTE This term includes contact lenses of plano power. 2.1.1.2 corneal contact

39、 lens contact lens having a total diameter less than the visible iris diameter and designed to be worn in its entirety on the cornea 2.1.1.3 scleral contact lens contact lens designed to be worn in front of the cornea and on the adjacent portion of the surrounding bulbar conjunctiva NOTE See 2.1.5 f

40、or specific terms concerning scleral contact lenses. 2.1.1.4 lenticular contact lens contact lens having a front optic zone made smaller than the total diameter NOTE This construction is conventionally used to reduce the centre thickness of a positive power contact lens or reduce the edge thickness

41、of a negative power contact lens. 2.1.1.5 contact shell contact lens not designed to correct vision BS EN ISO 18369-1:2006+A1:2009 EN ISO 18369-1:2006+A1:20092 2.1.1.6 scleral shell rigid contact shell with a scleral zone NOTE See 2.1.5 for specific terms concerning scleral shells. 2.1.1.7 rigid con

42、tact lens hard contact lens contact lens which, in its final form and under normal conditions, retains its form without support 2.1.1.8 rigid gas-permeable contact lens RGP contact lens hard gas-permeable contact lens (deprecated) rigid contact lens which contains one or more components in the conta

43、ct lens polymer in sufficient concentration to permit oxygen transmission through the contact lens 2.1.1.9 soft contact lens contact lens which requires support to maintain its form 2.1.1.10 hydrogel contact lens hydrophilic contact lens (deprecated) contact lens made of water-absorbing material hav

44、ing equilibrium water content greater than or equal to 10 % in standard saline solution at 20 C NOTE Standard saline solution is prepared as specified in ISO 18369-3. 2.1.1.11 composite contact lens contact lens composed of two or more different materials EXAMPLES Laminated lens, a fused segment len

45、s, or a lens with a rigid centre and a flexible periphery. 2.1.1.12 surface treated contact lens contact lens whose surfaces have been modified to make the surface characteristics different to those of the bulk material 2.1.1.13 bifocal contact lens multifocal contact lens having two optic zones, us

46、ually for distance and near-vision correction NOTE See 2.1.4 for specific terms concerning bifocal contact lenses. 2.1.1.14 multifocal contact lens contact lens designed to provide two or more zones of different corrective powers NOTE See 2.1.4 for specific terms concerning multifocal contact lenses

47、. 2.1.1.15 progressive power contact lens varifocal power contact lens contact lens designed to provide correction for more than one viewing range in which the power changes continuously, rather than discretely, over a part or the whole of the lens NOTE See 2.1.4 for specific terms concerning progre

48、ssive power contact lenses. BS EN ISO 18369-1:2006+A1:2009 EN ISO 18369-1:2006+A1:2009 3 2.1.1.16 contact lens accessory article intended specifically by its manufacturer to be used with a contact lens to enable the lens to be used in accordance with its intended purpose NOTE This term includes all

49、devices recommended for use in the hygienic management of contact lenses, for hydrating contact lenses, or alleviating discomfort of contact lens wear by physical means. 2.1.1.17 contact lens care product contact lens accessory intended for use in maintaining the safety and performance of a contact lens after opening and removal of the lens from its primary container NOTE See 2.1.9 and 2.1.11 for specific terms concerning contact lens care products and the hygienic management of contact lenses. 2