EN ISO 18369-3-2017 en Ophthalmic optics - Contact lenses - Part 3 Measurement methods.pdf

1、Ophthalmic optics - Contact lensesPart 3: Measurement methods (ISO 18369-3:2017)BS EN ISO 18369-3:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18369-3 September 2017 ICS 11.040.70 Supersedes EN ISO 18369

2、-3:2006English Version Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2017) Optique ophtalmique - Lentilles de contact - Partie 3: Mthodes de mesure (ISO 18369-3:2017) Augenoptik - Kontaktlinsen - Teil 3: Messverfahren (ISO 18369-3:2017) This European Standard was appr

3、oved 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 bibliographical references concerning such national st

4、andards 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

5、 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, Hungar

6、y, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CE

7、N-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18369-3:2017 ENational forewordThis British Standard is the UK implementation of EN ISO 18369-3:2017. It is ide

8、ntical to ISO 18369-3:2017. It supersedes BS EN ISO 18369-3:2006, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172/9, Contact lenses and contact lens care products.A list of organizations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 t

9、o 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 87559 5ICS 11.040.70Compliance with a British Stand

10、ard 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 ISO 183693:2017EUROPEAN STANDARD NORME EU

11、ROPENNE EUROPISCHE NORM EN ISO 18369-3 September 2017 ICS 11.040.70 Supersedes EN ISO 18369-3:2006English Version Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2017) Optique ophtalmique - Lentilles de contact - Partie 3: Mthodes de mesure (ISO 18369-3:2017) Augenoptik

12、 - Kontaktlinsen - Teil 3: Messverfahren (ISO 18369-3:2017) 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

13、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 lang

14、uage 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, Denmar

15、k, 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 and United Kingdom. EUROPEAN COM

16、MITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18369-3:2017 EBS EN

17、ISO 183693:2017EN ISO 18369-3:2017 (E) 3 European foreword This document (EN ISO 18369-3:2017) 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 St

18、andard shall be given the status of a national standard, either by publication 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 th

19、is document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 18369-3:2006. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound

20、 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,

21、 Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 18369-3:2017 has been approved by CEN as EN ISO 18369-3:2017 without any modification. ISO 18369-3:2017(E)Foreword iv1 Scope . 12 Normative references 13 Terms and defi

22、nitions . 14 Methods of measurement for contact lenses 14.1 General . 14.2 Radius of curvature . 24.2.1 General 24.2.2 Optical spherometry (rigid contact lenses) 34.2.3 Sagittal height method 64.3 Label back vertex power 114.3.1 General. 114.3.2 Focimeter specification . 114.3.3 Calibration 124.3.4

23、Focimeter measurement of rigid lenses .134.3.5 Focimeter measurement of hydrogel lenses .134.3.6 Measurement of hydrogel contact lenses by immersion in saline .134.3.7 Addition power measurement 144.4 Diameters and widths 144.4.1 Total diameter .144.4.2 Zone diameters and widths . 194.5 Thickness 20

24、4.5.1 General. 204.5.2 Dial gauge method .204.5.3 Low-force mechanical gauge method .214.6 Edge inspection . 224.7 Determination of inclusions and surface imperfections 224.8 Spectral transmittance 234.8.1 General. 234.8.2 Instrument specification, test conditions and procedure .234.9 Saline solutio

25、n for testing . 244.9.1 General. 244.9.2 Formulation .244.9.3 Preparation procedure 254.9.4 Packaging and labelling 255 Test report 26Annex A (informative) Measurement of rigid contact lens curvature using interferometry 27Annex B (informative) Measurement of label back vertex power of soft contact

26、lenses immersed in saline using the Moir deflectometer or Hartmann methods 29Annex C (informative) Measurement of the radius of curvature of contact lenses using the ophthalmometer .33Annex D (informative) Paddle support for focimeters used for power measurements of contact lenses .38Bibliography .4

27、0 ISO 2017 All rights reserved iiiContents PageBS EN ISO 183693:2017ISO 18369-3:2017(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Methods of measurement for contact lenses 14.1 General . 14.2 Radius of curvature . 24.2.1 General 24.2.2 Optical spherometry (rigid conta

28、ct lenses) 34.2.3 Sagittal height method 64.3 Label back vertex power 114.3.1 General. 114.3.2 Focimeter specification . 114.3.3 Calibration 124.3.4 Focimeter measurement of rigid lenses .134.3.5 Focimeter measurement of hydrogel lenses .134.3.6 Measurement of hydrogel contact lenses by immersion in

29、 saline .134.3.7 Addition power measurement 144.4 Diameters and widths 144.4.1 Total diameter .144.4.2 Zone diameters and widths . 194.5 Thickness 204.5.1 General. 204.5.2 Dial gauge method .204.5.3 Low-force mechanical gauge method .214.6 Edge inspection . 224.7 Determination of inclusions and surf

30、ace imperfections 224.8 Spectral transmittance 234.8.1 General. 234.8.2 Instrument specification, test conditions and procedure .234.9 Saline solution for testing . 244.9.1 General. 244.9.2 Formulation .244.9.3 Preparation procedure 254.9.4 Packaging and labelling 255 Test report 26Annex A (informat

31、ive) Measurement of rigid contact lens curvature using interferometry 27Annex B (informative) Measurement of label back vertex power of soft contact lenses immersed in saline using the Moir deflectometer or Hartmann methods 29Annex C (informative) Measurement of the radius of curvature of contact le

32、nses using the ophthalmometer .33Annex D (informative) Paddle support for focimeters used for power measurements of contact lenses .38Bibliography .40 ISO 2017 All rights reserved iiiContents PageBS EN ISO 183693:2017ISO 18369-3:2017(E)ForewordISO (the International Organization for Standardization)

33、 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 repre

34、sented 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.The procedures used to devel

35、op this document and those intended 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/

36、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 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during

37、 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 in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the vol

38、untary nature of standards, the meaning 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 .h

39、tml.This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This second edition cancels and replaces the first edition (ISO 18369-3:2006), which has been technically revised.A list of all parts in the ISO 18369 series c

40、an be found on the ISO website.iv ISO 2017 All rights reservedBS EN ISO 183693:2017ISO 18369-3:2017(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

41、 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 w

42、ork. 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 particular the dif

43、ferent 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 this documen

44、t 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 www .iso .org

45、/ 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 information

46、 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 instr

47、uments.This second edition cancels and replaces the first edition (ISO 18369-3:2006), which has been technically revised.A list of all parts in the ISO 18369 series can be found on the ISO website.iv ISO 2017 All rights reserved INTERNATIONAL STANDARD ISO 18369-3:2017(E)Ophthalmic optics Contact len

48、ses Part 3: Measurement methods1 ScopeThis document specifies the methods for measuring the physical and optical properties of contact lenses specified in ISO 18369-2, i.e. radius of curvature, label back vertex power, diameter, thickness, inspection of edges, inclusions and surface imperfections an

49、d determination of spectral transmittance. This document also specifies the equilibrating solution and standard saline solution for testing of contact lenses.2 Normative referencesThe following documents are referred to in the text 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 3696:1987, Water for analytical laboratory use Specification and