DIN EN ISO 11979-3-2013 Ophthalmic implants - Intraocular lenses - Part 3 Mechanical properties and test methods (ISO 11979-3 2012) German version EN ISO 11979-3 2012《眼科植入物 眼内透镜 第3.pdf

1、April 2013 Translation 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).ICS

2、11.040.70!$B“1999331www.din.deDDIN EN ISO 11979-3Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methods (ISO 11979-3:2012);English version EN ISO 11979-3:2012,English translation of DIN EN ISO 11979-3:2013-04Ophthalmische Implantate Intraokularlinsen Teil 3: Mechanisch

3、e Eigenschaften und Prfverfahren (ISO 11979-3:2012);Englische Fassung EN ISO 11979-3:2012,Englische bersetzung von DIN EN ISO 11979-3:2013-04Implants ophtalmiques Lentilles intraoculaires Partie 3: Proprits mcaniques et mthodes dessai (ISO 11979-3:2012);Version anglaise EN ISO 11979-3:2012,Traductio

4、n anglaise de DIN EN ISO 11979-3:2013-04SupersedesDIN EN ISO 11979-3:2006-07www.beuth.deDocument comprises 37 pagesIn case of doubt, the German-language original shall be considered authoritative.03.13DIN EN ISO 11979-3:2013-04 2 A comma is used as the decimal marker. National foreword This document

5、 (EN ISO 11979-3:2012) 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 preparation was the Normenausschuss Fei

6、nmechanik und Optik (Optics and Precision Mechanics Standards Committee), Working Committee NA 027-01-20 AA Intraokulare Medizinprodukte. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 11979-1 DIN EN ISO 11979-1 ISO 11979-2 DIN EN ISO

7、11979-2 Further standards dealing with intraocular lenses are listed in the National Annex NA. 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. Amendments This standard differs from

8、 DIN EN ISO 11979-3:2006-07 as follows: a) requirements for the mechanical properties of toric intraocular lenses and accommodating intraocular lenses have been included (see Subclause 4.1 and Clauses 5 and 6); b) the text of ISO 11979-3:2012 has been adopted in its entirety. Previous editions DIN E

9、N 13503-3: 2000-09 DIN EN ISO 11979-3: 2006-07 National Annex NA (informative) Bibliography DIN EN ISO 11979-1, Ophthalmic implants Intraocular lenses Part 1: Vocabulary DIN EN ISO 11979-2, Ophthalmic implants Intraocular lenses Part 2: Optical properties and test methods DIN EN ISO 11979-4, Ophthal

10、mic implants Intraocular lenses Part 4: Labelling and information DIN EN ISO 11979-5, Ophthalmic implants Intraocular lenses Part 5: Biocompatibility DIN EN ISO 11979-6, Ophthalmic implants Intraocular lenses Part 6: Shelf-life and transport stability DIN EN ISO 11979-7, Ophthalmic implants Intraocu

11、lar lenses Part 7: Clinical investigations DIN EN ISO 11979-8, Ophthalmic implants Intraocular lenses Part 8: Fundamental requirements DIN EN ISO 11979-9, Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses DIN EN ISO 11979-10, Ophthalmic implants Intraocular lenses Part 10:

12、 Phakic intraocular lenses EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11979-3 December 2012 ICS 11.040.70 Supersedes EN ISO 11979-3:2006English Version Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012) Implants ophtalmiques - L

13、entilles intraoculaires - Partie 3: Proprits mcaniques et mthodes dessai (ISO 11979-3:2012) Ophthalmische Implantate - Intraokularlinsen - Teil 3: Mechanische Eigenschaften und Prfverfahren (ISO 11979-3:2012) This European Standard was approved by CEN on 30 November 2012. CEN members are bound to co

14、mply 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 the CEN-CENEL

15、EC 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 notified to the CEN-CENELEC Management Centre has the

16、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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembou

17、rg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All

18、 rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11979-3:2012: EContents PageForeword Introduction 1 Scope .2 Normative references 3 Terms and definitions .4 Requirements 4.1 General .4.2 Tolerances and dimensions 4.3 Clearance analysi

19、s (anterior chamber lenses only) 4.4 Compression force .4.5 Axial displacement in compression 4.6 Optic decentration .4.7 Optic tilt .4.8 Angle of contact 4.9 Compression force decay .4.10 Dynamic fatigue durability .4.11 Surgical manipulation .4.12 Surface and bulk homogeneity 5 Recovery of propert

20、ies following simulated surgical manipulation 6 Additions for accommodating IOLs (AIOLs) Annex A (normative) Measurement of compression force .Annex B (normative) Measurement of axial displacement in compression Annex C (normative) Measurement of optic decentration .16Annex D (normative) Measurement

21、 of optic tilt19Annex E (normative) Measurement of angle of contact .Annex F (normative) Testing of compression force decay 26Annex G (normative) Testing of dynamic fatigue durability.27Annex H (informative) Measurement of loop pull strength 29Annex I (informative) Clearance analysis .Annex J (infor

22、mative) Precision .34Bibliography .353455555666677777888810132331EN ISO 11979-3:2012 (E) DIN EN ISO 11979-3:2013-04 2Foreword This document (EN ISO 11979-3:2012) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics“ in collaboration with Technical Committee CEN/TC 170 “Ophthalmi

23、c 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 endorsement, at the latest by June 2013, and conflicting national standards shall be withdrawn at the latest by June 2013. Atte

24、ntion 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. This document supersedes EN ISO 11979-3:2006. According to the CEN/CENELEC Internal Regula

25、tions, the national standards organisations of the following countries are bound 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, Ita

26、ly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11979-3:2012 has been approved by CEN as a EN ISO 11979-3:2012 without any modification. EN ISO

27、11979-3:2012 (E) DIN EN ISO 11979-3:2013-04 3 IntroductionThis part of ISO 11979 contains methods for which requirements are given and methods for which no requirements are formulated. The former are considered essential for the safety or performance of the intraocular lens, while the latter provide

28、 essential information to the ophthalmic surgeon or are used for other purposes.A special purpose is the use of mechanical data to assess the need for clinical investigation of modifications of existing models as described in ISO 11979-77. Because of the complexity of this analysis, detailed descrip

29、tions and examples have been given in ISO/TR 229798. Due to the wide variety of intraocular lens designs already on the market, it has not been possible to devise test methods that are applicable to every design under all circumstances. It can be anticipated that new materials currently under develo

30、pment will result in drastically new designs that will require modified or other test methods. As with all standards, it is then up to the parties using the standard to modify or develop corresponding methods and give rationale and validation for them in a spirit that is consistent with this part of

31、 ISO 11979.In cases where different tolerances have been given depending on material or design, they reflect an existing situation with well-established products.EN ISO 11979-3:2012 (E) DIN EN ISO 11979-3:2013-04 41 ScopeThis part of ISO 11979 specifies requirements and test methods for certain mech

32、anical properties of intraocular lenses (IOLs).It is applicable to all types of IOLs intended for implantation in the anterior segment of the human eye, excluding corneal implants, provided that the test method is appropriate to the particular IOL design.2 Normative referencesThe following reference

33、d 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 11979-1, Ophthalmic implants Intraocular lenses Part 1: VocabularyISO

34、 11979-2, Ophthalmic implants Intraocular lenses Part 2: Optical properties and test methods3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 11979-1 apply.4 Requirements4.1 GeneralFor all IOLs, the mechanical properties shall be determined at in situ c

35、onditions. The precise composition of the solution used shall be reported in all cases. Alternative test conditions, e.g. room temperature conditions, may be used if a justification to deviate from in situ is given. The alternative test conditions shall be specified in the test reports.For each of t

36、he methods described below, tests shall be performed on a minimum of three IOL lots of medium dioptric power. If dioptric power affects the property tested, the lots shall comprise one each of low, medium and high dioptric powers. For toric intraocular lenses, half of each of these three lots shall

37、contain intraocular lenses with the highest cylindrical power, and the other half shall contain intraocular lenses with the lowest cylindrical power. The minimum sample size for each test shall be 10 IOLs per lot. The lots shall be representative of IOLs being marketed. In all cases, the sampling cr

38、iteria applied shall be reported. Means and standard deviations shall be reported for the pooled samples.If, for certain designs and certain applications, a specific test method described in this part of ISO 11979 is not applicable, the IOL manufacturer can devise a corresponding test method and pro

39、vide a validation and rationale for it.For accommodating IOLs (AIOLs) the theoretical mechanism of action to change the power of the eye shall be described e.g. the change of curvature or the movement of lens elements under compression. The general factors determining this action shall be characteri

40、zed and specified. Further mechanical testing over a range that includes the maximum and minimum limits of the theoretical mechanism of EN ISO 11979-3:2012 (E) DIN EN ISO 11979-3:2013-04 5 action shall be performed. If the dynamic response to the mechanism of action is time dependent, this time depe

41、ndency shall be characterized.4.2 Tolerances and dimensionsThe tolerances for overall diameter, vault height and sagitta are given in Table 1.Table 1 Tolerances of overall diameter, vault height and sagittaTest method Overall diameter Vault height SagittaAnterior chamber IOLs 0,20 mm 0,15 mm 0,25 mm

42、Multi piece posterior chamber IOLs 0,30 mm 0,35 mm 0,45 mmOther IOLs 0,20 mm 0,25 mm 0,35 mmThe tolerance on the clear optic shall be 0,15 mm. The diameter of the clear optic shall be greater than 4,25 mm in any meridian. The tolerance on the dimensions of the body shall be 0,10 mm. For ellipsoid IO

43、Ls, the dimensions of the body shall be reported as (short axis) (long axis).The tolerance on the diameter of the positioning hole shall be nominal 0005+( ),mm.Dimensions for which tolerances are given above shall be specified in the manufacturers design documentation. Some dimensions may vary with

44、dioptric power, hence different specifications may apply to individual powers of an intraocular lens design.4.3 Clearance analysis (anterior chamber lenses only)An empirical analysis of anatomic placement shall be performed for anterior chamber lenses to evaluate the most proximate points with relat

45、ion to the anatomical structures of the eye. The clearance of the anterior surface of the IOL optic in relation to the endothelial layer of the cornea shall be determined for the lens at its minimum recommended diameter in its compressed state. In addition the separation between the posterior surfac

46、e of the IOL optic and the iris shall be determined. For phakic IOLs, the separation between the posterior surface of the IOL optic and the crystalline lens shall also be determined. These results shall be considered in the risk analysis. The theoretical eye model in Annex I can be used in the evalu

47、ation.The manufacturer shall strive for a clearance of at least 1 mm under worst-case conditions, i.e. conditions which would result in the minimum amount of clearance.4.4 Compression forceUsing the method described in Annex A, the compression force shall be measured and reported as follows:a) for I

48、OLs intended for capsular bag placement, with the haptics compressed to a diameter of 10 mm;b) for IOLs intended for sulcus placement, with the haptics compressed to a diameter of 11 mm;c) for IOLs intended for both capsular bag and sulcus placement, with the haptics compressed to both a diameter of

49、 10 mm and a diameter of 11 mm;d) for anterior chamber IOLs, with the haptics compressed to the minimum and maximum intended compressed diameters recommended by the manufacturer in the product literature.4.5 Axial displacement in compressionUsing the method described in Annex B, the axial displacement in compression shall be measured and r