DIN EN ISO 11979-2-2014 Ophthalmic implants - Intraocular lenses - Part 2 Optical properties and test methods (ISO 11979-2 2014) German version EN ISO 11979-2 2014《眼科植入物 眼内透镜 第2部分 .pdf

1、December 2014Translation by DIN-Sprachendienst.English price group 15No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC

2、S 11.040.70!%O0“2274413www.din.deDDIN EN ISO 11979-2Ophthalmic implants Intraocular lenses Part 2: Optical properties and test methods (ISO 11979-2:2014);English version EN ISO 11979-2:2014,English translation of DIN EN ISO 11979-2:2014-12Ophthalmische Implantate Intraokularlinsen Teil 2: Optische E

3、igenschaften und Prfverfahren (ISO 11979-2:2014);Englische Fassung EN ISO 11979-2:2014,Englische bersetzung von DIN EN ISO 11979-2:2014-12Implants ophtalmiques Lentilles intraoculaires Partie 2: Proprits optiques et mthodes dessai (ISO 11979-2:2014);Version anglaise EN ISO 11979-2:2014,Traduction an

4、glaise de DIN EN ISO 11979-2:2014-12SupersedesDIN EN ISO 11979-2:2000-07andDIN EN ISO 11979-2Corrigendum1:2005-07www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 30 pages11.14 DIN EN ISO 11979-2:2014-12 2 A comma is used as the decimal m

5、arker. National foreword This document (EN ISO 11979-2:2014) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (both secretariats are held by DIN, Germany). The responsible German body involved in its p

6、reparation was the DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-01-20 AA Intraokulare Medizinprodukte. DIN EN ISO 11979 consists of the following parts, under the general title Ophthalmic implants Intraocular lenses: Pa

7、rt 1: Vocabulary Part 2: Optical properties and test methods Part 3: Mechanical properties and test methods Part 4: Labelling and information Part 5: Biocompatibility Part 6: Shelf-life and transport stability testing Part 7: Clinical investigations Part 8: Fundamental requirements Part 9: Multifoca

8、l intraocular lenses Part 10: Phakic intraocular lenses The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 9334 DIN ISO 9334 ISO 9335 DIN ISO 9335 ISO 11979-1 DIN EN ISO 11979-1 ISO 11979-3 DIN EN ISO 11979-3 ISO 11979-4 DIN EN ISO 11979-4

9、 In Germany, use of the symbol “dpt” for dioptre (expressed in m1) is legally required and this symbol is to be used rather than the symbol D used in other countries. DIN EN ISO 11979-2:2014-12 3 Amendments This standard differs from DIN EN ISO 11979-2:2000-07 and DIN EN ISO 11979-2 Corrigendum 1:20

10、05-07 as follows: a) requirements and test methods for toric, multifocal, accommodating, and phakic intraocular lenses have been included; b) Annex A “Measurement of dioptric power” has been revised; c) Annex B “Measurement of resolution efficiency” has been revised; d) Annex C “Measurement of MTF”

11、has been revised; e) the former Annexes D, E, F and G have been deleted; f) the text of the revised version ISO 11979-2:2014 has been adopted in its entirety. Previous editions DIN EN ISO 11979-2: 2000-07 DIN EN ISO 11979-2 Corrigendum 1: 2005-07 DIN EN ISO 11979-2:2014-12 4 National Annex NA (infor

12、mative) Bibliography DIN EN ISO 11979-1, Ophthalmic implants Intraocular lenses Part 1: Vocabulary DIN EN ISO 11979-3, Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methods DIN EN ISO 11979-4, Ophthalmic implants Intraocular lenses Part 4: Labelling and information DI

13、N ISO 9334, Optics and photonics Optical transfer function Definitions and mathematical relationships DIN ISO 9335, Optics and photonics Optical transfer function Principles and procedures of measure-ment ISO 6328:2000, Photography Photographic materials Determination of ISO resolving power EN ISO 1

14、1979-2 August 2014 ICS 11.040.70 Supersedes EN ISO 11979-2:1999English Version Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014) Implants ophtalmiques - Lentilles intraoculaires - Partie 2:Proprits optiques et mthodes dessai(ISO 11979-2:2014)Op

15、hthalmische Implantate - Intraokularlinsen - Teil 2:Optische Eigenschaften und Prfverfahren(ISO 11979-2:2014)This European Standard was approved by CEN on 25 July 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European S

16、tandard 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 CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (Eng

17、lish, 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 has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium,

18、 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerlan

19、d, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11979-2:2014 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISAT

20、IONEUROPISCHES KOMITEE FR NORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMContents Page Foreword 3 Introduction 4 1 Scope 5 2 Normative references . 5 3 Terms and definitions 5 4 Requirements . 5 4.1 General . 5 4.2 Dioptric power 6 4.3 Determination of imaging quality . 7 4.4 Spectral transmi

21、ttance . 9 Annex A (normative) Measurement of dioptric power . 10 Annex B (normative) Measurement of resolution efficiency 18 Annex C (normative) Measurement of MTF 21 Bibliography . 26 DIN EN ISO 11979-2:2014-12 EN ISO 11979-2:2014 (E) 2ForewordThis document (EN ISO 11979-2:2014) has been prepared

22、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 endorseme

23、nt, at the latest by February 2015, and conflicting national standards shall be withdrawn at the latest by February 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 identif

24、ying any or all such patent rights. This document supersedes EN ISO 11979-2:1999. 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 Repub

25、lic, Denmark, Estonia, Finland, Former Yugoslav Republic 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. Endor

26、sement notice The text of ISO 11979-2:2014 has been approved by CEN as EN ISO 11979-2:2014 without any modification. “”DIN EN ISO 11979-2:2014-12EN ISO 11979-2:2014 (E)3IntroductionThis part of ISO 11979 initially addressed monofocal IOLs and now has been revised to include the requirements and test

27、 methods for spherical monofocal, aspheric monofocal, toric, multifocal, and accommodative IOLs. This part of ISO 11979 contains several test methods for which associated requirements are given and one test method for which no requirement is formulated. The former are directly connected to the optic

28、al functions of intraocular lenses. The latter, the test for spectral transmittance, has been provided for information about UV transmission and in specific situations, e.g. when using laser light sources for diagnosis and treatment.For the original spherical monofocal IOLs, extensive interlaborator

29、y testing was carried out before setting the limits specified. During this testing some basic problems were encountered as described in Reference 1. The accuracy in the determination of dioptric power has an error that is not negligible in relation to the half dioptre steps in which intraocular lens

30、es are commonly labelled. The dioptric power tolerances take this fact into account. Hence the limits set may lead to some overlap into the next labelled power, especially for high dioptre lenses. Reference 1 gives further discussion on this subject.The majority of lenses hitherto implanted were qua

31、lified using the method described in Annex B or Annex C (model eye 1). The method in Annex B is limited in its applicability, however. The limits for the more general method in Annex C have been set in terms of MTF in a model eye, following two approaches. The first is by correlation to the method a

32、nd limit in Annex B. Further discussion can be found in Reference2. The second is set as a percentage of what is calculated as theoretical maximum for the design, with the rationale that a minimum level of manufacturing accuracy be guaranteed. For common PMMA lenses, these two limits correspond well

33、 with each other. For lenses made of materials with lower refractive index, or with certain shape factors, or for extreme power lenses in general, the latter limit is lower than the former. However, such lenses are already in use, indicating clinical acceptance. The question of which is the absolute

34、 lowest limit that is compatible with good vision arises. No definite answer can be found, but following clinical data presented to the working group, an absolute lower limit has been set for the calculation method.DIN EN ISO 11979-2:2014-12 EN ISO 11979-2:2014 (E) 41 ScopeThis part of ISO 11979 spe

35、cifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or accommodative optics. The generic descriptor IOL used throughout this document also includes phakic intraocular lenses (PIOL).2 Norma

36、tive referencesThe following referenced documents are indispensable for the application 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 6328:2000, Photography Photogra

37、phic materials Determination of ISO resolving powerISO 9334, Optics and photonics Optical transfer function Definitions and mathematical relationshipsISO 9335, Optics and photonics Optical transfer function Principles and procedures of measurementISO 11979-1, Ophthalmic implants Intraocular lenses P

38、art 1: VocabularyISO 11979-3, Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methodsISO 11979-4, Ophthalmic implants Intraocular lenses Part 4: Labelling and information3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 119

39、79-1 and ISO 9334 apply.4 Requirements4.1 GeneralThe manufacturer shall demonstrate that the entire range of available powers meets the specifications herein. All optical properties apply at in situ conditions, either by being measured at simulated in situ conditions, or being measured at other cond

40、itions and then corrected to in situ conditions.For IOLs where the optic is intended to be deformed during implantation, it shall be demonstrated that dioptric power and imaging quality are retained at in situ conditions or equivalent following surgical manipulation and recovery. See ISO 11979-3 for

41、 more detail.The test methods described in this standard are reference methods. Alternative methods that produce equivalent results to those obtained with the reference methods can be used if the manufacturer can demonstrate that the IOLs meet the minimum dioptric power and imaging quality requireme

42、nts.DIN EN ISO 11979-2:2014-12EN ISO 11979-2:2014 (E)54.2 Dioptric power4.2.1 GeneralThe dioptric power of spherical or aspheric lenses as stated by the manufacturer in the IOL labelling shall be within the tolerance limits specified in Table 1. For rotationally symmetric lenses, these tolerances ap

43、ply in all meridians.Table 1 Tolerance limits on spherical dioptric power, SNominal spherical dioptric power rangeaDTolerance limits on spherical dioptric powerD0 S 15 0,315 S 25 0,425 S 30 0,530 S 1,0aThe ranges apply to positive as well as negative dioptric powers.4.2.2 Dioptric power for toric IO

44、L (TIOL)When determined by any of the methods in Annex A, the dioptric power in the meridians of highest and lowest dioptric power and the spherical equivalent (SE) power shall be within the tolerance limits for dioptric power specified in Table 1. Additionally, the cylindrical power calculated as t

45、he absolute difference between the powers of the meridian of highest dioptric power and the meridian of lowest dioptric power shall be within the cylindrical power tolerance limits specified in Table 2.Table 2 Tolerance limits on cylindrical dioptric power, CNominal cylindrical dioptric power rangeD

46、Tolerance limits on cylindrical dioptric powerDSE 25 DTolerance limits on cylindrical dioptric powerDSE 25 D0 C 2,5 0,3 0,42,5 C 4,5 0,4 0,44,5 C 0,5 0,5The TIOL shall have a physical axis indicator such as a mark, engraving, or label that aligns with the meridian of lowest dioptric power, and is vi

47、sible to the surgeon during implantation. The angle difference between the physical axis indicator and the meridian with the lowest dioptric power shall be less than or equal to 5,0.4.2.3 Dioptric power for multifocal IOL (MIOL)Methods A.2 to A.4 can be applied to MIOL for determining the far power

48、and any distinct near powers. When using A.2, dioptric power must be justified as a calculation based only on spherical surfaces. The dioptric power of the far power shall be within the tolerance limits specified in Table 1 and the dioptric power of the addition power(s) shall be within the toleranc

49、es in Table 3.DIN EN ISO 11979-2:2014-12 EN ISO 11979-2:2014 (E) 6Table 3 Tolerance limits on addition dioptric power, ANominal addition dioptric power rangeDTolerance limits on addition dioptric powerDfar power 25 DTolerance limits on addition dioptric powerDfar power 25 D0 A 2,5 0,3 0,42,5 A 4,5 0,4 0,44,5 A 0,5 0,54.2.4 Dioptric power for accommodating IOL (AIOL