EN ISO 11979-3-2012 en Ophthalmic implants - Intraocular lenses - Part 3 Mechanical properties and test methods《眼科植入物 人工晶体 第3部分 机械性能和测试方法》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11979-3:2012Ophthalmic implants Intraocular lensesPart 3: Mechanical properties and testmethods (ISO 11979-3:2012)BS EN ISO 11979-3:2012 BRITISH STANDARDNational forewo

2、rdThis British Standard is the UK implementation of EN ISO11979-3:2012. It supersedes BS EN ISO 11979-3:2006 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/172/7, Eye implants.A list of organizations represented on this committee can beobtained on re

3、quest to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 70880 0ICS 11.040.70Compliance with a British

4、Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 December 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11979-3 Decemb

5、er 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 - Lentilles intraoculaires - Partie 3: Proprits mcaniques et mthodes dessai (ISO 11979-3:2012) Ophtha

6、lmische 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 comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Euro

7、pean 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-CENELEC Management Centre or to any CEN member. This European Standard exists in three official version

8、s (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 same status as the official versions. CEN members are the national standards bodies of Austria, Be

9、lgium, 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, Swit

10、zerland, 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 rights of exploitation in any form and by any means reserved worldwide for CEN national Members.

11、Ref. No. EN ISO 11979-3:2012: EBS EN ISO 11979-3:2012EN ISO 11979-3:2012 (E) 3 Foreword 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 “Ophthalmic optics” the secretariat of which is

12、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. Attention is drawn to the possibility that

13、 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 Regulations, the national standards organisa

14、tions 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, Italy, Latvia, Lithuania, Luxembourg, Mal

15、ta, 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. BS EN ISO 11979-3:2012ISO 11979-3:2012(E) ISO

16、 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 14.1 General . 14.2 Tolerances and dimensions 24.3 Clearance analysis (anterior chamber lenses only) 24.4 Compression force . 24.5 Axial displacement in com

17、pression 24.6 Optic decentration . 34.7 Optic tilt . 34.8 Angle of contact 34.9 Compression force decay . 34.10 Dynamic fatigue durability . 34.11 Surgical manipulation . 44.12 Surface and bulk homogeneity 45 Recovery of properties following simulated surgical manipulation 46 Additions for accommoda

18、ting IOLs (AIOLs) 4Annex A (normative) Measurement of compression force 6Annex B (normative) Measurement of axial displacement in compression . 9Annex C (normative) Measurement of optic decentration .12Annex D (normative) Measurement of optic tilt15Annex E (normative) Measurement of angle of contact

19、 .19Annex F (normative) Testing of compression force decay 22Annex G (normative) Testing of dynamic fatigue durability.23Annex H (informative) Measurement of loop pull strength 25Annex I (informative) Clearance analysis .27Annex J (informative) Precision .30Bibliography .31BS EN ISO 11979-3:2012ISO

20、11979-3:2012(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 carried out through ISO technical committees. Each member body interested in a subject

21、 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 work. ISO collaborates closely with the International Electrotechnical Commission (IEC)

22、on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees a

23、re circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.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 r

24、esponsible for identifying any or all such patent rights.ISO 11979-3 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This third edition cancels and replaces the second edition (ISO 11979-3:2006), which has been technically re

25、vised in order to include relevant requirements and test methods for toric intraocular lenses and accommodating intraocular lenses.ISO 11979 consists of the following parts, under the general title Ophthalmic implants Intraocular lenses: Part 1: Vocabulary Part 2: Optical properties and test methods

26、 Part 3: Mechanical properties and test methods Part 4: Labelling and information Part 5: Biocompatibility Part 6: Shelf-life and transport stability Part 7: Clinical investigations Part 8: Fundamental requirements Part 9: Multifocal intraocular lenses Part 10: Phakic intraocular lensesiv ISO 2012 A

27、ll rights reservedBS EN ISO 11979-3:2012ISO 11979-3:2012(E)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 l

28、atter provide 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, det

29、ailed descriptions 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

30、 under development 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

31、 this part of ISO 11979.In cases where different tolerances have been given depending on material or design, they reflect an existing situation with well-established products. ISO 2012 All rights reserved vBS EN ISO 11979-3:2012BS EN ISO 11979-3:2012Ophthalmic implants Intraocular lenses Part 3: Mec

32、hanical properties and test methods1 ScopeThis part of ISO 11979 specifies requirements and test methods for certain mechanical 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

33、, provided that the test method is appropriate to the particular IOL design.2 Normative 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 referen

34、ced document (including any amendments) applies.ISO 11979-1, Ophthalmic implants Intraocular lenses Part 1: VocabularyISO 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 giv

35、en in ISO 11979-1 apply.4 Requirements4.1 GeneralFor all IOLs, the mechanical properties shall be determined at in situ conditions. 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 justificati

36、on to deviate from in situ is given. The alternative test conditions shall be specified in the test reports.For each of the 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 compris

37、e one each of low, medium and high dioptric powers. For toric intraocular lenses, half of each of these three lots shall 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 e

38、ach test shall be 10 IOLs per lot. The lots shall be representative of IOLs being marketed. In all cases, the sampling criteria 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 d

39、escribed in this part of ISO 11979 is not applicable, the IOL manufacturer can devise a corresponding test method and provide 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 curv

40、ature or the movement of lens elements under compression. The general factors determining this action shall be characterized and specified. Further mechanical testing over a range that includes the maximum and minimum limits of the theoretical mechanism of INTERNATIONAL STANDARD ISO 11979-3:2012(E)

41、ISO 2012 All rights reserved 1BS EN ISO 11979-3:2012ISO 11979-3:2012(E)action shall be performed. If the dynamic response to the mechanism of action is time dependent, this time dependency shall be characterized.4.2 Tolerances and dimensionsThe tolerances for overall diameter, vault height and sagit

42、ta 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 mmMulti 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

43、 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 IOLs, the dimensions of the body shall be reported as (short axis) (long axis).The tolerance on the diameter of the posi

44、tioning 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 dioptric power, hence different specifications may apply to individual powers of an intraocular lens design.4.3 Cleara

45、nce 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 relation to the anatomical structures of the eye. The clearance of the anterior surface of the IOL optic in relation to the

46、 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 surface of the IOL optic and the iris shall be determined. For phakic IOLs, the separation between the posterior surface of

47、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 evaluation.The manufacturer shall strive for a clearance of at least 1 mm under worst-case conditions, i.e. conditions whic

48、h 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 IOLs intended for capsular bag placement, with the haptics compressed to a diameter of 10 mm;b) for IOLs intended for s

49、ulcus 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 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